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| Name | Class |
|---|---|
| RUSSCO (Russian Society of Clinical Oncology) | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OVATAR study patients | Females with serous and endometrioid ovarian, peritoneal and fallopian tube cancer 18 years and older, diagnosed 3 months before enrolment into the study or later, consented to participate in this non-interventional study, who are being treated for OC, FTC (Fallopian Tube Cancer) and PC (Peritoneal Cancer) in the oncology hospitals/departments in the Russian Federation. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Data collection of disease information (including genetic testing results) |
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Inclusion Criteria:
Exclusion Criteria:
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Females with serous and endometrioid ovarian, peritoneal and fallopian tube cancer 18 years and older, diagnosed 3 months before enrolment into the study or later, consented to participate in this non-interventional study, who are being treated for OC, FTC and PC in the oncology hospitals/departments in the Russian Federation.
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| Name | Affiliation | Role |
|---|---|---|
| Karin Otter | AstraZeneca | Study Director |
| Vera Gorbunova | Russian Cancer Research Center named after NN Blokhin | Principal Investigator |
| Alexandra Tyulandina | Russian Cancer Research Center named after NN Blokhin | Principal Investigator |
| Larisa Kolomietz | Research Oncology Center, Tomsk | Study Chair |
| Tatiana Kekeeva | Research Centre for Medical Genetics, Moscow | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Arkhangelsk | Russia | ||||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Data collection of disease information (including genetic testing results) |
| up to 14 months |
| 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 |
| 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 |
| 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 |
| 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 |
| Chelyabinsk |
| Russia |
| Research Site | Irkutsk | Russia |
| Research Site | Izhevsk | Russia |
| Research Site | Kaluga | Russia |
| Research Site | Khabarovsk | Russia |
| Research Site | Moscow | Russia |
| Research Site | Novorossiysk | Russia |
| Research Site | Novosibirsk | Russia |
| Research Site | Obninsk | Russia |
| Research Site | Omsk | Russia |
| Research Site | Orenburg | Russia |
| Research Site | Pyatigorsk | Russia |
| Research Site | Rostov-on-Don | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Samara | Russia |
| Research Site | Sochi | Russia |
| Research Site | Tomsk | Russia |
| Research Site | Tula | Russia |
| Research Site | Tver' | Russia |
| Research Site | Ufa | Russia |
| Research Site | Vladimir | Russia |
| D005184 |
| Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |