Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT03229122
• Lead Sponsor: AstraZeneca

Brief Summary

The multi-centered, cross-sectional investigations shall be conducted in this study with the objective of identifying the ownership ratio of gBRCAm on the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.

Detailed Description

This multi-centered, cooperative and epidemiological observation study is so designed to investigate the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer because such a ratio has not yet been adequately clarified in Japan.

The newly diagnosed eligible patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer shall be asked to participate in this study in order of diagnosis. After obtaining their consents by the written informed consent following appropriate explanation, investigations about the demographic information including the cancer family history shall be performed. Subsequently, blood is collected for investigation about gBRCAm. In addition, histological classification shall be conducted based on the resected tumor tissues.

Study Timeline

• Study Start: 2016-12-26
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-07-24
• Study First Posted: 2017-07-25
• Primary Completion: 2018-07-06
• Study Completion: 2018-07-06
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 446

Inclusion Criteria

For registration to this study, all of the following criteria should be satisfied:

1. The subject can attach the signature to the Informed Consent Form (ICF), besides having his/her intention to put the signature.
2. Female Japanese at more than 20 years of age
3. The newly diagnosed patients whose epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer is histologically confirmed as FIGO from the subject to obtain their utmost understandings. Limited to histopathological diagnosis based on resected tumor specimens (except the cytodiagnosis by ascites paracentesis).
4. The histopathological specimens can be submitted to the central pathological judgment.
5. Within 60 days after diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, the patient's written consent has been obtained.

Exclusion Criteria

• The subjects who coincide any of the following exclusion criteria are designated to be ineligible:

  1. In case of the subjects who are diagnosed to have acute or chronic physical or severe mental diseases except cancer, and about whom the attending responsible physician makes judgement to say that participation of these subjects would possibly increase the risks or would probably disturb the interpretation of the study results.
  2. In case of the subjects whose registration for the study is judged by the attending responsible physician as inappropriate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.	Baseline	To be evaluated based on laboratory test.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the satisfaction levels of the patients toward explanation about the BRCA genetic testing	Baseline	To be evaluated by questionnaire
Ownership ratio of gBRCAm when stratified according to the patients' demographics	Baseline	To be evaluated by laboratory test

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamagata, Japan