Ovarian, Peritoneal, Fallopian Tube Cancer, BRCAm+ in Russia Clinical Trial
— OVATAROfficial title:
OVArian Cancer Non-Interventional Study. Treatment hAbits and Epidemiology of BRCA in Russian Federation - OVATAR
| Verified date | May 2019 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 503 |
| Est. completion date | May 31, 2018 |
| Est. primary completion date | May 31, 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Research Site | Archangelsk | |
| Russian Federation | Research Site | Chelyabinsk | |
| Russian Federation | Research Site | Irkutsk | |
| Russian Federation | Research Site | Izhevsk | |
| Russian Federation | Research Site | Kaluga | |
| Russian Federation | Research Site | Khabarovsk | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Novorossiysk | |
| Russian Federation | Research Site | Novosibirsk | |
| Russian Federation | Research Site | Obninsk | |
| Russian Federation | Research Site | Omsk | |
| Russian Federation | Research Site | Orenburg | |
| Russian Federation | Research Site | Pyatigorsk | |
| Russian Federation | Research Site | Rostov-on-Don | |
| Russian Federation | Research Site | Samara | |
| Russian Federation | Research Site | Sochi | |
| Russian Federation | Research Site | St.Petersburg | |
| Russian Federation | Research Site | Tomsk | |
| Russian Federation | Research Site | Tula | |
| Russian Federation | Research Site | Tver | |
| Russian Federation | Research Site | Ufa | |
| Russian Federation | Research Site | Vladimir |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | RUSSCO (Russian Society of Clinical Oncology) |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of 1st line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN (International Nonproprietary Name), doses, regimen) | Evaluation of 1st line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN, doses, regimen) | up to 14 months | |
| Secondary | Data collection of patients characteristics (gender, age, race, co-morbidities, family history of ovarian and breast cancer) | Data collection of patients characteristics (gender, age, race, co-morbidities, family history of ovarian and breast cancer) | up to 14 months | |
| Secondary | Data collection of disease information (including genetic testing results) | Data collection of disease information (including genetic testing results) | up to 14 months | |
| Secondary | Proportion of BRCAm+ among serous and endometrioid ovarian, peritoneal and fallopian tube cancer in Russia. | Proportion of BRCAm+ among serous and endometrioid ovarian, peritoneal and fallopian tube cancer in Russia. | up to 14 months | |
| Secondary | Evaluation of response to 1st line chemotherapy treatment of serous and endometrioid BRCAm+ ovarian, peritoneal and fallopian tube cancer | Evaluation of response to 1st line chemotherapy treatment of serous and endometrioid BRCAm+ ovarian, peritoneal and fallopian tube cancer | up to 3 months | |
| Secondary | Assessment of relapses after 1st line of Pt (Platinum)-containing regimen for BRCAm+ patients | Assessment of relapses after 1st line of Pt-containing regimen for BRCAm+ patients | up to 3 months | |
| Secondary | 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 | 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 | up to 3 months |