UMIN-CTR Clinical Trial

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

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

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

AstraZeneca K.K.

Institute

Department

Personal name

Organization

AstraZeneca K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

01

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2017

Year

01

Month

10

Day

Last modified on

2019

Year

01

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029460