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

NCT03229122 | Completed

• 1 other identifier: D0816R00013
• Study Type: observational
• Target: 446
• Locations: 1 country
• Sites: 35

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.

Conditions

Ovarian Cancer

Keywords

ovarian cancer, gBRCAm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Ownership ratio of gBRCAm when stratified according to the patients' demographics

  Baseline

• Evaluation of the satisfaction levels of the patients toward explanation about the BRCA genetic testing

  Baseline

Eligibility Criteria

• Age: 20 Years - 130 Years
• Gender Eligibility Details: Female Japanese at more than 20 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• For registration to this study, all of the following criteria should be satisfied:
• The subject can attach the signature to the Informed Consent Form (ICF), besides having his/her intention to put the signature.
• Female Japanese at more than 20 years of age
• 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).
• The histopathological specimens can be submitted to the central pathological judgment.
• Within 60 days after diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, the patient's written consent has been obtained.

You may not qualify if:

• 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.
• In case of the subjects whose registration for the study is judged by the attending responsible physician as inappropriate.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (35)

Research Site

Aichi, Japan

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Akita, Japan

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Aomori, Japan

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Chiba, Japan

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Fukuoka, Japan

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Fukushima, Japan

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Gifu, Japan

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Hyōgo, Japan

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Ibaraki, Japan

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Izumo, Japan

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Kanagawa, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Maebashi, Japan

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Matsuyama, Japan

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Mie, Japan

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Miyagi, Japan

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Morioka, Japan

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Nagano, Japan

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Nagasaki, Japan

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Nara, Japan

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Niigata, Japan

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Okayama, Japan

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Okinawa, Japan

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Osaka, Japan

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Saga, Japan

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Saitama, Japan

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Sapporo, Japan

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Sendai, Japan

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Tochigi, Japan

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Tokushima, Japan

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Tokyo, Japan

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Tottori, Japan

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Tōon, Japan

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Yamagata, Japan

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Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

From all the eligible subjects who have already attached the signature to the written informed consent, blood samples shall be collected. By using an assigned 10-mL EDTA-added blood collecting glass tube, 7 mL of the blood is sampled. The blood samples are to be recovered together with the specified test request form by Myriad and presence or absence of gBRCAm shall be centrally determined by US Myriad Genetics. Treatments of the samples, handling procedures and recovery methods are precisely described on the testing manual. The physician responsible for institutional study has the responsibility to notify the gBRCAm results to all the patients who underwent the tests. However, this responsibility needs not to be observed if the patients themselves refuse such a notification about gBRCAm test results. This responsibility shall be assumed by the physician responsible for institutional study in each participating institute. Incidentally, the genetic test results of the patients should

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Toru Sugiyama, MD

  Iwate Medical University

  PRINCIPAL INVESTIGATOR

• 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.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: July 25, 2017
• Study Start: December 26, 2016
• Primary Completion: July 6, 2018
• Study Completion: July 6, 2018
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (35)