Ovarian, Peritoneal, Fallopian Tube Cancer, BRCAm+ in Russia Clinical Trial
Official title:
OVArian Cancer Non-Interventional Study. Treatment hAbits and Epidemiology of BRCA in Russian Federation - OVATAR
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.
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.
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