Clinical trial NCT03229122: Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA
Official title: Japan CHARLOTTE: Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: ovarian cancer, gBRCAm
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-07-25
Enrollment: 446
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Baseline
Secondary outcomes:
measure: Ownership ratio of gBRCAm when stratified according to the patients' demographics
timeFrame: Baseline
measure: Evaluation of the satisfaction levels of the patients toward explanation about the BRCA genetic testing
timeFrame: Baseline
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
city: Akita
country: Japan
facility: Research Site
city: Aomori
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Izumo
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Maebashi
country: Japan
facility: Research Site
city: Matsuyama
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Miyagi
country: Japan
facility: Research Site
city: Morioka
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Nara
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Okinawa
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saga
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Sapporo
country: Japan
facility: Research Site
city: Sendai
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Tokushima
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Toon
country: Japan
facility: Research Site
city: Tottori
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
Study officials:
affiliation: Iwate Medical University
name: Toru Sugiyama, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Keio University
name: Daisuke Aoki, MD
role: STUDY_DIRECTOR
affiliation: School of Medicine, Niigata University
name: Takayuki Enomoto, MD. PhD.
role: STUDY_DIRECTOR
affiliation: The Cancer Institute Hospital Of JFCR.
name: Nobuhiro Takeshima, MD.
role: STUDY_DIRECTOR
affiliation: The Matsue City Hospital
name: Junzo Kigawa, MD, PhD
role: STUDY_DIRECTOR
affiliation: The Tohoku Medical and Pharmaceutical University
name: Yo Watanabe
role: STUDY_DIRECTOR
affiliation: The Cancer Institute Hospital Of JFCR.
name: Masami Arai, MD. PhD.
role: STUDY_DIRECTOR
References: