OVArian Cancer Non-Interventional Study - OVATAR
Conditions
1st Line Treatment and Diagnostic Serous or Endometrioid Ovarian, Peritoneal, Fallopian Tube Cancer, BRCAm+Occurence in Russia
Conditions: official terms
Fallopian Tube Neoplasms - Ovarian Neoplasms
Conditions: Keywords
serous and endometrioid ovarian, peritoneal, fallopian tube cancer, hereditary ovarian cancer, BRCA (breast cancer gene) mutation, genetic testing
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
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.
Detailed Description
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 2 additional once a year visits besides screening/baseline visit are 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Female
Criteria: 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.
Locations
Research Site
Archangelsk, Russian Federation
Status: Recruiting
Research Site
Chelyabinsk, Russian Federation
Status: Not yet recruiting
Research Site
Irkutsk, Russian Federation
Status: Recruiting
Research Site
Izhevsk, Russian Federation
Status: Recruiting
Research Site
Kaluga, Russian Federation
Status: Recruiting
Research Site
Khabarovsk, Russian Federation
Status: Recruiting
Research Site
Moscow, Russian Federation
Status: Recruiting
Research Site
Moscow, Russian Federation
Status: Not yet recruiting
Research Site
Novorossiysk, Russian Federation
Status: Not yet recruiting
Research Site
Novosibirsk, Russian Federation
Status: Recruiting
Research Site
Obninsk, Russian Federation
Status: Not yet recruiting
Research Site
Omsk, Russian Federation
Status: Recruiting
Research Site
Orenburg, Russian Federation
Status: Not yet recruiting
Research Site
Pyatigorsk, Russian Federation
Status: Not yet recruiting
Research Site
Samara, Russian Federation
Status: Recruiting
Research Site
Sochi, Russian Federation
Status: Not yet recruiting
Research Site
St.Petersburg, Russian Federation
Status: Recruiting
Research Site
Tomsk, Russian Federation
Status: Recruiting
Research Site
Tula, Russian Federation
Status: Not yet recruiting
Research Site
Tver, Russian Federation
Status: Recruiting
Research Site
Ufa, Russian Federation
Status: Recruiting
Research Site
Vladimir, Russian Federation
Status: Not yet recruiting
Start Date
June 2014
Completion Date
March 2018
Sponsors
AstraZeneca
Source
AstraZeneca
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page