OVArian Cancer Non-Interventional Study - OVATAR

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by AstraZeneca
Sponsor:
Collaborator:
RUSSCO (Russian Society of Clinical Oncology)
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02122588
First received: April 23, 2014
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition
1st Line Treatment and Diagnostic Serous or Endometrioid Ovarian, Peritoneal, Fallopian Tube Cancer, BRCAm+Occurence in Russia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: OVArian Cancer Non-Interventional Study. Treatment hAbits and Epidemiology of BRCA in Russian Federation - OVATAR

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Evaluation of 1st line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN, doses, regimen)


Secondary Outcome Measures:
  • Data collection of patients characteristics (gender, age, race, co-morbidities, family history of ovarian and breast cancer) [ Time Frame: up to 14 months ] [ Designated as safety issue: No ]
    Data collection of patients characteristics (gender, age, race, co-morbidities, family history of ovarian and breast cancer)

  • Data collection of disease information (including genetic testing results) [ Time Frame: up to 14 months ] [ Designated as safety issue: No ]
    Data collection of disease information (including genetic testing results)

  • Proportion of BRCAm+ among serous and endometrioid ovarian, peritoneal and fallopian tube cancer in Russia. [ Time Frame: up to 14 months ] [ Designated as safety issue: No ]
    Proportion of BRCAm+ among serous and endometrioid ovarian, peritoneal and fallopian tube cancer in Russia.

  • 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 ] [ Designated as safety issue: No ]
    Evaluation of response to 1st line chemotherapy treatment of serous and endometrioid BRCAm+ ovarian, peritoneal and fallopian tube cancer

  • Assessment of relapses after 1st line of Pt (Platinum)-containing regimen for BRCAm+ patients [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    Assessment of relapses after 1st line of Pt-containing regimen for BRCAm+ patients

  • 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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 300
Study Start Date: June 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02122588

Contacts
Contact: Vera Karaseva +7 495 799 56 99 ClinicalTrialTransparency@astrazeneca.com
Contact: Olga Vedrova +7 495 799 56 99 Olga.Vedrova@astrazeneca.com

Locations
Russian Federation
Research Site Not yet recruiting
Arkhangelsk, Russian Federation
Research Site Not yet recruiting
Barnaul, Russian Federation
Research Site Not yet recruiting
Chelyabinsk, Russian Federation
Research Site Not yet recruiting
Irkutsk, Russian Federation
Research Site Not yet recruiting
Izhevsk, Russian Federation
Research Site Not yet recruiting
Kaluga, Russian Federation
Research Site Not yet recruiting
Kazan, Russian Federation
Research Site Not yet recruiting
Khabarovsk, Russian Federation
Research Site Not yet recruiting
Krasnodar, Russian Federation
Research Site Not yet recruiting
Moscow, Russian Federation
Research Site Recruiting
Moscow, Russian Federation
Research Site Not yet recruiting
Murmansk, Russian Federation
Research Site Not yet recruiting
Novosibirsk, Russian Federation
Research Site Not yet recruiting
Obninsk, Russian Federation
Research Site Not yet recruiting
Omsk, Russian Federation
Research Site Not yet recruiting
Orenburg, Russian Federation
Research Site Not yet recruiting
Pyatigorsk, Russian Federation
Research Site Not yet recruiting
Rostov-on-Don, Russian Federation
Research Site Not yet recruiting
Saint-Petersburg, Russian Federation
Research Site Recruiting
Tomsk, Russian Federation
Research Site Not yet recruiting
Tula, Russian Federation
Research Site Not yet recruiting
Tver, Russian Federation
Research Site Not yet recruiting
Ufa, Russian Federation
Sponsors and Collaborators
AstraZeneca
RUSSCO (Russian Society of Clinical Oncology)
Investigators
Study Director: Karin Otter AstraZeneca
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02122588     History of Changes
Other Study ID Numbers: NIS-ORU-XXX-2014/1
Study First Received: April 23, 2014
Last Updated: August 8, 2014
Health Authority: Russia: Independent Interdisciplinary Committee of ethical review of clinical trials

Keywords provided by AstraZeneca:
serous and endometrioid ovarian, peritoneal, fallopian tube cancer, hereditary ovarian cancer, BRCA (breast cancer gene) mutation, genetic testing

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on August 21, 2014