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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03229122

Acronym

CHARLOTTE

Enrollment

446

Registered

2017-07-25

Start date

2016-12-26

Completion date

2018-07-06

Last updated

2019-06-10

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

Conditions

Ovarian Cancer

Keywords

ovarian cancer, gBRCAm

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 130 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Japan

Outcome results