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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025597
Receipt No. R000029460
Scientific Title CHARacterizing the cross-sectionaL approach to Ovarian cancer: geneTic TEsting of BRCA
Date of disclosure of the study information 2017/01/10
Last modified on 2019/01/09

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Basic information
Public title CHARacterizing the cross-sectionaL approach to Ovarian cancer: geneTic TEsting of BRCA
Acronym Japan CHARLOTTE
Scientific Title CHARacterizing the cross-sectionaL approach to Ovarian cancer: geneTic TEsting of BRCA
Scientific Title:Acronym Japan CHARLOTTE
Region
Japan

Condition
Condition The newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 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.
Basic objectives2 Others
Basic objectives -Others 1.Ownership ratio of gBRCAm when stratified according to the patients demographics
2.Evaluation of the satisfaction levels of the patients toward explanation about the BRCA genetic testing
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary objectives of this study are to investigate the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, which has been inadequately clarified in Japan so far.
Key secondary outcomes 1.Ownership ratio of gBRCAm when stratified according to the patients demographics
2.Evaluation of the satisfaction levels of the patients toward explanation about the BRCA genetic testing


Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1.The subject can attach the signature to the Informed Consent Form (ICF), besides having 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 FIGOs Stage I to Stage IV. However, diagnosis should be based on the histopathological diagnosis on the surgically 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 patients written consent has been obtained.
Key exclusion criteria 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.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigetaka Kouda
Organization AstraZeneca K.K.
Division name Medical Evidence & Observational Research
Zip code
Address Grand Front Osaka Tower B3-1, Ofuka-cho, Kita-ku, Osaka
TEL 06-7711-3714
Email Shigetaka.Kouda@astrazeneca.com

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuru Shimomura
Organization CMIC HOLDINGS Co., Ltd.
Division name BIU
Zip code
Address Hamamatsucho Bldg., 1-1-1 Shibaura, Minato-ku, Tokyo
TEL 03-6779-8013
Homepage URL
Email charlotte@cmic.co.jp

Sponsor
Institute AstraZeneca K.K.
Institute
Department

Funding Source
Organization AstraZeneca K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study have been prepared a plan to conduct the multi-centered, cooperative and large scale cross-sectional investigations 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. As the secondary evaluation, the ownership ratio of gBRCAm according to patients demographics shall be investigated in this study. It can be expected that these data shall contribute to diagnosis and therapy selection for the benefit of the gBRCAm carrier patients in future.

Management information
Registered date
2017 Year 01 Month 10 Day
Last modified on
2019 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029460

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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