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

Ovarian Cancer Clinical Trial

— CHARLOTTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03229122
• Other study ID #: D0816R00013
• Status: Completed
• Start date: December 26, 2016
• Est. completion date: July 6, 2018

Study information

• Verified date: June 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: July 6, 2018
• Est. primary completion date: July 6, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
Japan	Research Site	Aichi
Japan	Research Site	Akita
Japan	Research Site	Aomori
Japan	Research Site	Chiba
Japan	Research Site	Fukuoka
Japan	Research Site	Fukushima
Japan	Research Site	Gifu
Japan	Research Site	Hyogo
Japan	Research Site	Ibaraki
Japan	Research Site	Izumo
Japan	Research Site	Kanagawa
Japan	Research Site	Kumamoto
Japan	Research Site	Kyoto
Japan	Research Site	Maebashi
Japan	Research Site	Matsuyama
Japan	Research Site	Mie
Japan	Research Site	Miyagi
Japan	Research Site	Morioka
Japan	Research Site	Nagano
Japan	Research Site	Nagasaki
Japan	Research Site	Nara
Japan	Research Site	Niigata
Japan	Research Site	Okayama
Japan	Research Site	Okinawa
Japan	Research Site	Osaka
Japan	Research Site	Saga
Japan	Research Site	Saitama
Japan	Research Site	Sapporo
Japan	Research Site	Sendai
Japan	Research Site	Tochigi
Japan	Research Site	Tokushima
Japan	Research Site	Tokyo
Japan	Research Site	Toon
Japan	Research Site	Tottori
Japan	Research Site	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

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

External Links

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