There is one clinical trial.
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.
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. --- C61G ---
Description: Evaluation of 1st line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN, doses, regimen)
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) Time: up to 14 monthsDescription: Data collection of patients characteristics (gender, age, race, co-morbidities, family history of ovarian and breast cancer)
Measure: Data collection of patients characteristics (gender, age, race, co-morbidities, family history of ovarian and breast cancer) Time: up to 14 monthsDescription: Data collection of disease information (including genetic testing results)
Measure: Data collection of disease information (including genetic testing results) Time: up to 14 monthsDescription: Proportion of BRCAm+ among serous and endometrioid ovarian, peritoneal and fallopian tube cancer in Russia.
Measure: Proportion of BRCAm+ among serous and endometrioid ovarian, peritoneal and fallopian tube cancer in Russia. Time: up to 14 monthsDescription: Evaluation of response to 1st line chemotherapy treatment of serous and endometrioid BRCAm+ ovarian, peritoneal and fallopian tube cancer
Measure: Evaluation of response to 1st line chemotherapy treatment of serous and endometrioid BRCAm+ ovarian, peritoneal and fallopian tube cancer Time: up to 3 monthsDescription: Assessment of relapses after 1st line of Pt-containing regimen for BRCAm+ patients
Measure: Assessment of relapses after 1st line of Pt (Platinum)-containing regimen for BRCAm+ patients Time: up to 3 monthsDescription: 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
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 Time: up to 3 months