Clinical trial NCT04578132: Description of the Population With Genitourinary Tumors and COVID-19
Official title: Observational Retrospective-prospective Study in Patients With Genitourinary Tumors Presenting COVID-19 Infection (SOGUG-COVID-19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Genito Urinary Cancer
Keywords: Urothelial cancer
prostate cancer
Germ line cancer
Kidney cancer
COVID-19
Lead sponsor: Spanish Oncology Genito-Urinary Group
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered COVID-19 infection prior to cancer treatment, during treatment, or after treatment.

Brief summary: The identification of patients with genitourinary tumors who suffer from the infection by the Serious Acute Respiratory Syndrome Corona-Virus 2 (SARS-CoV-2) virus can represent multiple benefits both for themselves and for health professionals and the health system itself. We would be able to know more precisely the clinical evolution of these type of patient, to know their prognosis and being capable to select the most appropriate treatment modality for future pandemics.

SOGUG-COVID is an observational prospective-retrospective trial purely epidemiological, that aims to describe the population with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) infected by COrona VIrus Disease 19 (COVID-19) treated in Spanish hospitals, learn about the clinical presentation, therapeutic evolution and prognosis of said intercurrent infectious process, as well as its possible relationship with different clinical and therapeutic factors.

Detailed description: The study will be carried out in Spanish hospitals, with principal investigators belonging to the medical oncology services of the SOGUG group (Spanish Group of Genitourinary Oncology), who will act as promoter. Once the patients have been selected, the variables of interest will be collected and studied. The main variables to record will be:

1. Patient characteristics
2. Hospital center where the patient is recruited
3. Pathological history:

   Concomitant pathology Usual drug treatment
4. Tumor pathology:

   Tumor type, histology, and stage (initial and at diagnosis of infection) Cancer diagnosis date Active cancer treatment or follow-up Participation in clinical trial Type of treatment most recently received for the infection (Surgery; Radiotherapy; Chemotherapy, Immunotherapy ...) Treatment lines, initiation and last dose received of the most recent most recent cancer treatment
5. COVID-19 infection:

   Confirmation date of COVID-19 infection PCR (Polymerase Chain Reaction) diagnostic test Immunoglobulin G (IgG) or Immunoglobulin M (IgM) serological diagnostic test Present symptoms, analytical alterations, thrombosis associated with COVID-19 infection, complications of infection Date of onset and disappearance of symptoms Days of fever and cough Radiological examination at the time of greatest severity Treatments received for COVID-19 Status upon discharge Date of discharge / exitus Negative presence of virus by PCR and PCR date
6. For patients who are receiving or have received immunotherapy treatments, additional information will be collected:

   Immunotherapy treatment line and type Start / end date and last dose previous infection of the treatment with immunotherapy Adverse effects
7. Prospective follow-up data (6 months from patient inclusion):

Date of start or restart of cancer treatment after infection Change / suspension of cancer treatment after COVID-19 Date of surgery in neoadjuvant patients Recurrence of COVID-19 Best response obtained Date of progression to cancer treatment Current status and date of last contact The study will use the data obtained from the patient's medical history, with no plans to use other sources.

The assignment of a patient to a specific therapeutic strategy has already been decided in advance by the usual clinical practice of medicine; The decision to prescribe a specific treatment is clearly dissociated from the decision to include a patient in the study. No intervention will be applied to patients, whether diagnostic or follow-up, that is not the usual clinical practice. Epidemiological methods will be used to analyze the collected data.

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years old.
* Diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ).
* COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
* The COVID-19 infection must be confirmed by PCR or serology, regardless of whether or not the patient requires hospitalization for the infection, additionally, a clinical and / or radiological determination must be available in those patients who present symptoms.

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Age at Baseline
timeFrame: Baseline, at the time of inclusion
measure: Frequency of Complications of COVID-19 Intercurrent Infection
timeFrame: Through study completion, average 1 year
measure: Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment
timeFrame: Through study completion, average 1 year
measure: Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment
timeFrame: Through study completion, average 1 year
measure: Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy)
timeFrame: Through study completion, average 1 year
measure: Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
timeFrame: Through study completion, average 1 year. Measured at 3 scenarios (during treatment, after treatment and therapies indicated after infection has passed)
Secondary outcomes:
measure: COVID-19 Mortality Rate in Patients With Genitourinary Cancer
timeFrame: Through study completion, average 1 year
measure: COVID-19 Complication Rate in Patients With Genitourinary Cancer
timeFrame: Through study completion, average 1 year
measure: Asymptomatic Rate
timeFrame: Through study completion, average 1 year
measure: Asymptomatic Rate in Renal Cancer
timeFrame: Through study completion, average 1 year
measure: Asymptomatic Rate in Urothelial Cancer
timeFrame: Through study completion, average 1 year
measure: Asymptomatic Rate in Prostate Cancer
timeFrame: Through study completion, average 1 year
measure: Asymptomatic Rate in Testicular Cancer
timeFrame: Through study completion, average 1 year
measure: Frequency of Delays/Modifications on Cancer Treatment Schedule
timeFrame: Through study completion, average 1 year
measure: Progression Free Survival in Patients With Genitourinary Tumors That Suffered COVID-19, Patients With a First Line Treatment Ongoing at the Moment of COVID Infection
timeFrame: From start of treatment until progression or death, up to 130 months
measure: Overall Survival in Patients With Genitourinary Tumors That Suffered COVID-19
timeFrame: From start of treatment until progression or death, up to 130 months
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Institut Català d'Oncologia L'Hospitalet
state: Barcelona
city: Manresa
country: Spain
facility: Althaia
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Taulí
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro-Majadahonda
state: Madrid
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d Hebron
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Ciudad Real
country: Spain
facility: Hospital de Ciudad Real
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Girona
country: Spain
facility: Instituto Catalán de Oncología- Girona
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos de Madrid
city: Madrid
country: Spain
facility: Hospital Infanta Leonor,
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Quironsalud
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Orense
country: Spain
facility: Complejo Hospitalario Universitario Ourense
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Talavera De La Reina
country: Spain
facility: Hospital Nuestra Señora del Prado
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Vitoria
country: Spain
facility: Hospital Txagorritxu
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Instituto Valenciano de Oncología
name: Miguel Ángel Climent, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Hospital Clínico San Carlos de Madrid
name: Javier Puente, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Hospital Universitario Puerta de Hierro-Majadahonda
name: Aránzazu González del Alba, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Hospital Universitario Lucus Augusti
name: Sergio Vázquez Estevez, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Hospital Clínico San Carlos de Madrid
name: Natalia Vidal, M.D., Ph.D.
role: STUDY_CHAIR
References: