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CHARacterizing the cross-sectionaL approach to Ovarian cancer: geneTic TEsting of BRCA

CHARacterizing the cross-sectionaL approach to Ovarian cancer: geneTic TEsting of BRCA - Japan CHARLOTTE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000025597
Enrollment
600
Registered
2017-01-10
Start date
2016-12-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

Interventions

None listed

Sponsors

AstraZeneca K.K.
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.The subject can attach the signature to the Informed Consent Form (ICF), besides having 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 FIGOs Stage I to Stage IV. However, diagnosis should be based on the histopathological diagnosis on the surgically 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 patients written consent has been obtained.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
The primary objectives of this study are to investigate the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, which has been inadequately clarified in Japan so far.

Secondary

MeasureTime frame
1.Ownership ratio of gBRCAm when stratified according to the patients demographics 2.Evaluation of the satisfaction levels of the patients toward explanation about the BRCA genetic testing

Countries

Japan

Contacts

Public ContactMitsuru Shimomura

CMIC HOLDINGS Co., Ltd. BIU

charlotte@cmic.co.jp03-6779-8013

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026