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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:
Fallopian tube carcinoma
Ovarian neoplasm
Genes 86
VAMP7 ZFPM2 CTNNB1 PTEN AKT1 WT1 FGFR2 AKT1 OPCML SOX9 BRCA2 BRCA1 PTEN MLH1 SUFU EWSR1 PMS2 IDH1 LMNA RAD51C RAD51C STAG3 GATA4 PALLD PIK3CA CHEK2 BRIP1 MRE11 FGFR2 TP53 RAD51D PRKN MSH6 EPCAM WT1 NR0B1 WT1 KRAS DICER1 TGFBR2 IDH2 SRY BRCA1 FAN1 DMRT3 MSH3 TP53 KRAS NR5A1 INHBA RNF43 KEAP1 DICER1 BARD1 SMAD4 RAD50 MSH2 NBN WNT10A C11ORF95 MLH3 PTCH2 CDH1 WRN PTEN PALB2 MAP3K1 PIK3CA RELA MAP3K1 PALB2 WT1 PMS2 BRCA2 PTEN BRCA1 RAD51 BRCA1 BRCA2 PTCH1 FLI1 PTEN PMS1 PTCH1 CDKN2A WWOX