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

June 6, 2019 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

446

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • 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, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline
To be evaluated based on laboratory test.
Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Toru Sugiyama, MD, Iwate Medical University
  • Study Director: Daisuke Aoki, MD, Keio University
  • Study Director: Takayuki Enomoto, MD. PhD., School of Medicine, Niigata University
  • Study Director: Nobuhiro Takeshima, MD., The Cancer Institute Hospital Of JFCR.
  • Study Director: Junzo Kigawa, MD, PhD, The Matsue City Hospital
  • Study Director: Yo Watanabe, The Tohoku Medical and Pharmaceutical University
  • Study Director: Masami Arai, MD. PhD., The Cancer Institute Hospital Of JFCR.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2016

Primary Completion (Actual)

July 6, 2018

Study Completion (Actual)

July 6, 2018

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

July 24, 2017

First Posted (Actual)

July 25, 2017

Study Record Updates

Last Update Posted (Actual)

June 10, 2019

Last Update Submitted That Met QC Criteria

June 6, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0816R00013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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