Clinical trial NCT03942263: A Study to Describe Treatment Patterns and Disease Control in Participants With cHL and sALCL in Routine Clinical Practice in the Russian Federation
Official title: KLIO - Non-interventional Multicenter Prospective and Retrospective Study to Describe Treatment Patterns and Disease Control in Patients With Classical Hodgkin's Lymphoma (cHL) and Systemic Anaplastic Large Cell Lymphoma (sALCL) in Routine Clinical Practice in the Russian Federation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin Disease
Lymphoma, Large-cell, Anaplastic
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2019-05-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with newly diagnosed cHL or sALCL, or with RR cHL or RR sALCL at the time of enrollment, or with RR cHL or RR sALCL within 3 years prior to inclusion in the study will be observed both retrospectively and prospectively.

Brief summary: The purpose of this study is to describe patterns of treatment used for cHL and sALCL in real world setting.

Detailed description: This is a non-interventional, prospective and retrospective study of participants with cHL and sALCL. The study will collect information on therapy and outcome of cHL and sALCL in real-life clinical practice.

The study will enroll approximately 2000 participants. Based on the diagnosis of the disease, participants will be assigned to one of the following groups:

* Newly Diagnosed and RR cHL Participants
* Newly Diagnosed and RR sALCL Participants

This multi-center trial will be conducted in Russia. The retrospective data will be collected for the participants with RR cHL or RR sALCL at the time of enrollment and for participants with RR cHL or RR sALCL within 3 years prior to inclusion in the study at Visit 1 (Baseline). The prospective data will be collected for a period of 2 years from Visit 1 (Baseline) to Visit 5 (Month 24, Final Visit), both for newly diagnosed participants with cHL or sALCL and participants with RR cHL or RR sALCL at the time of enrolment, and participants with RR cHL or RR sALCL within 3 years prior to inclusion in the study.

Eligibility criteria: Inclusion Criteria:

1. Male and female participants 18 years or older by the time of enrollment.
2. Histologically confirmed diagnosis of cHL or sALCL.
3. Newly diagnosed participants, or participants with RR cHL or RR sALCL at the time of enrollment, or participants with RR cHL or RR sALCL within 3 years prior to inclusion in the Study.

Exclusion Criteria:

1. Unconfirmed diagnosis of cHL or sALCL.
2. Current, previous (within the last 3 years) or planned (for the next 2 years) participation in interventional clinical trials.
3. Participation in the non-interventional study CHL-5001 "An international, multi-centre, non-interventional retrospective study to describe treatment pathways, outcomes, and resource use in participants with classical Hodgkin lymphoma (B-HOLISTIC)" (Sponsor is Takeda Pharmaceuticals International AG).
4. Participants for whom the minimum study dataset was not available from their hospital medical records.

Primary outcomes:
measure: Description of Treatment Patterns Used for cHL or sALCL
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants Receiving Various Chemotherapy Regimens
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants who Received Chemotherapy Regimens as per National Guidelines
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants who Received Radiotherapy Including Site (Extended/Involved) and Total Dosing
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants who Received Autologous Stem Cell Transplantation (AutoSCT)
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants who Were Eligible for AutoSCT did not Receive it (Including Reasons)
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants who Received Allogeneic Stem Cell Transplantation (AlloSCT)
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Distribution of Pre-SCT Therapy Regimens
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Distribution of First Line Treatment Patterns According to Prognostic Group
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Distribution of Relapse/Refractory (RR) Treatment Patterns
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From the date of cHL or sALCL diagnosis confirmation until the date of death from any cause or till the latest date of participant observed (up to Month 24)
measure: Disease Free Survival-1 (DSF1)
timeFrame: From date of complete remission after first line of therapy up to relapse or till the latest date of participant observed (up to Month 24)
measure: Freedom From Treatment Failure-1 (FFTF1)
timeFrame: From date of initiation first therapy until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till observed (up to Month 24)
measure: Event Free Survival-1 (EFS1)
timeFrame: From date of initiation first therapy until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24)
measure: Percentage of Participants with Complete Remission (CR) Achieved by the end of Treatment Regimen
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants With Partial Remission (PR) Achieved by the end of Treatment Regimen
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants With Overall Response Achieved by the end of Treatment Regimen
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants With Stable Disease (SD) Achieved by the end of Treatment Regimen
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants With Progression Disease (PD) While on the Treatment
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants With Relapse (Both Early [<12 Months After the end of First Line Treatment] and Late Relapses)
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants With Primary Resistance
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Resistant Participants to the Second and Later Treatment Lines
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants in Whom Brentuximab Vedotin was Used
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Distribution of Treatment Patterns Containing Brentuximab Vedotin in Clinical Practice
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Disease Free Survival (DFS) After the Treatment Line Including Brentuximab Vedotin Based on the Number of Cycles of Brentuximab Vedotin Performed Within this Treatment Line
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: FFTF Based on the Number of Cycles of Brentuximab Vedotin Performed Within the Treatment Line
timeFrame: From initiation therapy date until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complication, death from any cause, or till observed (up to Month 24)
measure: EFS Based on the Number of Cycles of Brentuximab Vedotin Performed Within this Treatment Line
timeFrame: From initiation therapy date until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24)
measure: Percentage of Participants With CR Achieved to the end of the Given Treatment Regimen Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants With Overall Response Achieved to the end of the Given Treatment Regimen Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants With Progressive Disease Developed While on the Treatment Regimen Including Brentuximab Vedotin Achieved Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Number of Cycles of Brentuximab Vedotin Before and After Stem Cell Transplantation (SCT)
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Distribution of Clinical Variables for cHL and sALCL at the Time of Primary Diagnosis
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Distribution of Clinical Variables for cHL and sALCL at the Time of Resistance/Relapses
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants for Whom PET and PET/Computed Tomography (CT) was Used for Primary Disease Diagnostic and Staging
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants for Whom PET and PET/CT Scan was Used for Interim Treatment Response Evaluation
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: OS Based on use of PET/CT Scan for Initial Disease Staging, Interim and Final Response Assessment During Frontline and Second Line Treatment
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Timepoint of Performing Interim Response Evaluation With PET/CT Scan (Number of Cycle After Which the Evaluation is Performed, Time From the Start of Last Cycle of Therapy)
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of Participants for Whom PET and PET/CT Scan Were Used to Evaluate Final Treatment Response
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Timepoint of Performing Final Response Evaluation With PET/CT scan (Number of Cycle After Which the Evaluation is Performed, Time From the Start of Last Cycle of Therapy)
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Time of Performing PET and PET/CT Scan After SCT
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Distribution of Imaging Patterns Used for Primary Disease Diagnostic and Staging in Different Regions of Russia
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Distribution of Imaging Patterns Used for Treatment Response Evaluation
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Distribution of Imaging Patterns Used for Disease Control of the Participants Being in Remission
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Percentage of cHL or sALCL Participants who Used Healthcare Resources: Hospitalizations, Sick Leave Sheet
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Number of Hospitalizations
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Number of Days Spent on Hospital Beds
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Number of Sick Leaves
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Number of Days Spent on Sick Leaves
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
measure: Disease Free Survival-2 (DSF2)
timeFrame: From date of complete remission after second line of therapy up to relapse or till the latest date of participant observed (up to Month 24)
measure: Freedom From Treatment Failure-2 (FFTF2)
timeFrame: From date of initiation second therapy until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till observed (up to Month 24)
measure: Event Free Survival-2 (EFS2)
timeFrame: From date of initiation second therapy until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24)
measure: Number of Cycles of Brentuximub Vedotin Administered in Routine Clinical Practice
timeFrame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Other outcomes:
Locations:
city: Astrakhan
country: Russian Federation
facility: State budgetary healthcare institution of the Astrakhan region Alexander-Mariinsky regional clinical hospital
city: Cheboksary
country: Russian Federation
facility: Autonomous Institution "Republican Clinical Oncology Dispensary" of the Ministry of Health of Chuvashia
city: Chelyabinsk
country: Russian Federation
facility: State budgetary health care institution "Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine"
city: Irkutsk
country: Russian Federation
facility: State Budget Public Health Institution "Regional Oncological Dispensary"
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Clinical Oncologic Dispensary
city: Kazan
country: Russian Federation
facility: Tatarstan Regional Clinical Cancer Center
city: Kemerovo
country: Russian Federation
facility: State budgetary institution of health care of the Kemerovo region "Regional Clinical Oncology Center"
city: Khabarovsk
country: Russian Federation
facility: Regional State Budgetary Institution of Health "Regional Clinical Hospital 1" named after Professor S.I. Sergeeva, Ministry of Health of the Khabarovsk Territory
city: Kirov
country: Russian Federation
facility: Federal State Budgetary Institution of Science "Kirov Research Institute of Hematology and Blood Transfusion of the Federal Medical and Biological Agency"
city: Kostroma
country: Russian Federation
facility: Regional State Budgetary Institution of Health "Kostroma Oncological Dispensary"
city: Krasnoyarsk
country: Russian Federation
facility: Regional State Budgetary Institution of Health "Regional Clinical Hospital"
city: Krasnoyarsk
country: Russian Federation
facility: Regional State Budgetary Institution of Healthcare Krasnoyarsk Regional Clinical Oncologic Dispensary named after A.I. Kryzhanovsky"
city: Lipetsk
country: Russian Federation
facility: Public health institution Lipetsk Regional Oncology Center
city: Magnitogorsk
country: Russian Federation
facility: State budgetary health care institution "Regional Oncology Center 2"
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "Main Military Clinical Hospital named after Academician N.N.Burdenko" of the Ministry of Defense of the Russian Federation
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "National Medical-Surgical Center named after N.I. Pirogov" Ministry of Health of the Russian Federation
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "National Medical Research Center of Oncology named after N.N. Blokhina "of the Ministry of Health of the Russian Federation
city: Moscow
country: Russian Federation
facility: The Moscow State Clinical Hospital No. 52 of the Moscow City Department of Healthcare, State Budgetary Institution of Health Care
city: Moscow
country: Russian Federation
facility: Federal State Institution National Medical Research Center of Hematology of the Ministry of Health of the Russian Federation
city: Moscow
country: Russian Federation
facility: Moscow City Hematology Center on the basis of the State Budgetary Institution of Healthcare of the City of Moscow City Clinical Hospital named after S.P. Botkin Moscow Department of Health
city: Moscow
country: Russian Federation
facility: State Budgetary Institution of Healthcare of the Moscow Region Moscow Regional Research Clinical Institute named after M.F. Vladimirskoye
city: Nizhny Novgorod
country: Russian Federation
facility: State Budgetary Healthcare Facility of Nizhny Novgorod Region "City Clinical Hospital 12"
city: Nizhny Novgorod
country: Russian Federation
facility: State budgetary institution of health care of the Nizhny Novgorod region "Regional Clinical Hospital named after NA Semashko"
city: Novosibirsk
country: Russian Federation
facility: State Budgetary Institution of Healthcare of the Novosibirsk Region "City Clinical Hospital No. 2"
city: Novosibirsk
country: Russian Federation
facility: Federal State Budgetary Institution of Public Health of the Novosibirsk Region "Research Institute of Fundamental and Clinical Immunology"
city: Novosibirsk
country: Russian Federation
facility: State Budgetary Institution of Healthcare of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
city: Obninsk
country: Russian Federation
facility: Medical Radiological Research Center. A.F. Tsyba - a branch of the Federal State Budgetary Institution "Scientific Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation
city: Omsk
country: Russian Federation
facility: Budget institution of healthcare of Omsk region "Clinical Oncologic dispensary"
city: Orenburg
country: Russian Federation
facility: State budgetary institution of public health "Orenburg regional clinical hospital 1"
city: Penza
country: Russian Federation
facility: The State Budgetary Institution of Healthcare "Regional Oncologic Dispensary"
city: Petrozavodsk
country: Russian Federation
facility: State Budgetary Institution of Healthcare of the Republic of Karelia Republican Hospital named after V. A. Baranova "
city: Pskov
country: Russian Federation
facility: State Budgetary Institution of Healthcare "Pskov Regional Clinical Oncologic Dispensary"
city: Rostov-on-Don
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education Rostov State Medical University of the Ministry of Health of the Russian Federation
city: Ryazan
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education Ryazan State Medical University named after Academician I.P. Pavlova" of the Ministry of Health of the Russian Federation
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "North-Western State Medical University named after II Mechnikov" of the Ministry of Health of the Russian Federation
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution "Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency"
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution "N. N. Petrov National Medical Research Center of Oncology" of the Ministry of Health of Russia
city: Saint-Petersburg
country: Russian Federation
facility: State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital
city: Saratov
country: Russian Federation
facility: Saratov State Medical University named after V.I.Razumovsky of the Ministry of Health of Russia "Clinic of Physiopathology and Hematology named after Professor V.Ya. Shustov"
city: Sochi
country: Russian Federation
facility: Study State Budgetary Institution of Health "Oncology Dispensary No. 2" of the Ministry of Health of the Krasnodar Territory
city: Stavropol
country: Russian Federation
facility: State Budgetary Institution of Healthcare of the Stavropol Territory "Stavropol Regional Clinical Oncology Dispensary"
city: Surgut
country: Russian Federation
facility: Budgetary institution of the Khanty-Mansiysk Autonomous Okrug Ugra
city: Syktyvkar
country: Russian Federation
facility: State institution of the Komi Republic "Komi Republican Oncological Dispensary"
city: Tula
country: Russian Federation
facility: State Healthcare Institution of Tula Region "Tula Regional Clinical Hospital"
city: Tyumen
country: Russian Federation
facility: State autonomous health care institution of the Tyumen region "Multidisciplinary clinical medical center "Medical City"
city: Ufa
country: Russian Federation
facility: Ministry of Health of the Republic of Bashkortostan State Autonomous Healthcare Institution Republican Clinical Oncologic Dispensary
city: Ulyanovsk
country: Russian Federation
facility: State Healthcare Institution "Regional Clinical Oncologic Dispensary"
city: Volgograd
country: Russian Federation
facility: State budgetary health care institution "Volgograd Regional Clinical Oncology Center"
city: Vologda
country: Russian Federation
facility: Budget institution of health care of the Vologda region "Vologda regional clinical hospital"
city: Yaroslavl
country: Russian Federation
facility: State budgetary institution of health care of the Yaroslavl region "Regional Clinical Hospital"
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: