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Report for Clinical Trial NCT02122588

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT02122588 Ovarian, Peritoneal, Fallopian Tube Cancer, BRCAm+ in Russia
MeSH:Ovarian Neoplasms Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms
HPO:Fallopian tube carcinoma Ovarian neoplasm


Primary Outcomes

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 months

Secondary Outcomes

Description: 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 months

Description: Data collection of disease information (including genetic testing results)

Measure: Data collection of disease information (including genetic testing results)

Time: up to 14 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 C61G

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 ---



HPO Nodes


HPO: