OVArian Cancer Non-Interventional Study - OVATAR (OVATAR)

May 17, 2019 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

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 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.

Study Type

Observational

Enrollment (Actual)

503

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • 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, Russian Federation
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
Time Frame: up to 14 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data collection of patients characteristics (gender, age, race, co-morbidities, family history of ovarian and breast cancer)
Time Frame: up to 14 months
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)
Time Frame: up to 14 months
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.
Time Frame: up to 14 months
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
Time Frame: up to 3 months
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
Time Frame: up to 3 months
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
Time Frame: 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
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

RUSSCO (Russian Society of Clinical Oncology)

Investigators

  • Principal Investigator: Vera Gorbunova, Russian Cancer Research Center named after NN Blokhin
  • Principal Investigator: Alexandra Tyulandina, Russian Cancer Research Center named after NN Blokhin
  • Study Chair: Larisa Kolomietz, Research Oncology Center, Tomsk
  • Study Chair: Tatiana Kekeeva, Research Centre for Medical Genetics, Moscow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2014

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

April 23, 2014

First Submitted That Met QC Criteria

April 23, 2014

First Posted (Estimate)

April 24, 2014

Study Record Updates

Last Update Posted (Actual)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-ORU-XXX-2014/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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