Clinical trial NCT02122588: OVArian Cancer Non-Interventional Study - OVATAR
Official title: OVArian Cancer Non-Interventional Study. Treatment hAbits and Epidemiology of BRCA in Russian Federation - OVATAR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian, Peritoneal, Fallopian Tube Cancer, BRCAm+ in Russia
Keywords: serous and endometrioid ovarian, peritoneal, fallopian tube cancer, hereditary ovarian cancer, BRCA (breast cancer gene) mutation, genetic testing
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: RUSSCO (Russian Society of Clinical Oncology)
First posted: 2014-04-24
Enrollment: 503
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females with serous and endometrioid ovarian, peritoneal and fallopian tube cancer 18 years and older, diagnosed 3 months before enrolment into the study or later, consented to participate in this non-interventional study, who are being treated for OC, FTC and PC in the oncology hospitals/departments in the Russian Federation.

Brief summary: This is a multicentre, non-interventional, prospective study to be carried out in representative hospitals in order to assess 1st line treatment management and diagnostic approaches applied to ovarian, peritoneal and fallopian tube cancer management in Russia and assess patients' characteristics and the occurrence of BRCA (Breast Cancer gene) mutations among Russian women with serous and endometrioid ovarian, peritoneal and fallopian tube cancer. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.

Detailed description: This is a multicentre, non-interventional, prospective study to be carried out in representative hospitals in order to assess ovarian, fallopian tube and peritoneal cancer management in Russia. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.

It is planned to enrol 300 subjects in up to 30 sites in Russian Federation. The average number of patients per site is planned as 10-15; there are no restrictions on minimum and maximum number of subjects per site in this study.

The disease treatments approaches in 1st line treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (both chemotherapy and surgery) is considered as the primary outcome variable in this study.

Along with other diagnosis examinations the analysis of frequent mutations in the gen BRCA1 (5382insC, 4154delA, 185delAG and C61G (c.300T\>G)) will be performed by local or regional laboratories.

Those patients with BRCAm+ OC (Ovarian Cancer) will be observed prospectively during 2 years after the baseline visit or till progression at the 1st line treatment with regards to OC treatment details and outcomes. The patients for whom BRCA mutations not found will participate in the baseline assessments only and will not be followed up. Accordingly, 1 study visit (screening/baseline) is planned for all patients and 1 FU visit (Year 2) is planned for BRCAm+ patients.

The subpopulation of the patients with the congenital serous and endometrioid ovarian, peritoneal and fallopian tube cancer with the corresponding family history will undergo the broadened genetic testing panel (sequencing of all coding areas of genes BRCA1 and BRCA2).

Information regarding patient demographics, the disease characteristics, management approaches, diagnostic tests performed and medication received by the patient will be taken from the medical records.

Eligibility criteria: Inclusion Criteria:

1. The voluntary obtained informed consent signed by both the subject and the investigator.
2. Confirmed serous and endometrioid ovarian cancer or fallopian tube cancer or peritoneal cancer diagnosed 3 months before enrolment into the study or later
3. Patients on treatment for OC (Ovarian Cancer) or FTC (Fallopian Tube Cancer) or PC (Peritoneal Cancer)

Exclusion Criteria:

1. The ovarian cancer histology other than serous and endometrioid.
2. Patients participating in clinical studies.
3. Any medical condition which on the opinion of the investigator may interfere the patient's participation in the trial.

Primary outcomes:
measure: Evaluation of 1st line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN (International Nonproprietary Name), doses, regimen)
timeFrame: up to 14 months
Secondary outcomes:
measure: Data collection of patients characteristics (gender, age, race, co-morbidities, family history of ovarian and breast cancer)
timeFrame: up to 14 months
measure: Data collection of disease information (including genetic testing results)
timeFrame: up to 14 months
measure: Proportion of BRCAm+ among serous and endometrioid ovarian, peritoneal and fallopian tube cancer in Russia.
timeFrame: up to 14 months
measure: Evaluation of response to 1st line chemotherapy treatment of serous and endometrioid BRCAm+ ovarian, peritoneal and fallopian tube cancer
timeFrame: up to 3 months
measure: Assessment of relapses after 1st line of Pt (Platinum)-containing regimen for BRCAm+ patients
timeFrame: up to 3 months
measure: Evaluation of 2nd line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN, doses, regimen) for BRCAm+ patients who have progressed after 1st line chemotherapy
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Archangelsk
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Kaluga
country: Russian Federation
facility: Research Site
city: Khabarovsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novorossiysk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Orenburg
country: Russian Federation
facility: Research Site
city: Pyatigorsk
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Sochi
country: Russian Federation
facility: Research Site
city: St.Petersburg
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Tula
country: Russian Federation
facility: Research Site
city: Tver
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Vladimir
country: Russian Federation
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Karin Otter
role: STUDY_DIRECTOR
affiliation: Russian Cancer Research Center named after NN Blokhin
name: Vera Gorbunova
role: PRINCIPAL_INVESTIGATOR
affiliation: Russian Cancer Research Center named after NN Blokhin
name: Alexandra Tyulandina
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Oncology Center, Tomsk
name: Larisa Kolomietz
role: STUDY_CHAIR
affiliation: Research Centre for Medical Genetics, Moscow
name: Tatiana Kekeeva
role: STUDY_CHAIR
References: