UMIN-CTR Clinical Trial

Basic information
Public title	Genomic examination and analysis for hereditary malignant tumors
Acronym	Genomic examination and analysis for hereditary malignant tumors
Scientific Title	Genomic examination and analysis for hereditary malignant tumors
Scientific Title:Acronym	Genomic examination and analysis for hereditary malignant tumors
Region	Japan

Condition
Condition	herediraty breast and ovarian cancer, Cowden disease, Li-fraumeni syndrome, familial adenomatous polyposis, hereditary non-poliposis colon cancer
Classification by specialty	Gastrointestinal surgery Breast surgery Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To establish programs of treatment and postoperative follow-up for hereditary cancer patients by accumulating the data of genomic mutations.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy of early detection program of hereditary cancers based on the results of genomic test
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Gene
Interventions/Control_1	Genetic test for BRCA1 and BRCA2 mutations
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	Male and Female
Key inclusion criteria	1. Patients with suspected herediary malignand disease. 2. Relatives of patients with comfirmed hereditary malignant disease. 3. Healthy members of a pedigree of suspected hereditary malignant disease.
Key exclusion criteria	1. Not enough for the criteria of the disease. 2. Client who doesn't receive pre-counseling. 3. Client younger than 20 y.o. 4. Client without a consent. 5. Client who cannot pay for the genetic test. 6. Client unsuitable for genetic test based on the ethical issue.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuhiro Tamaki
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Breast and Endocrine Surgery
Zip code
Address	1-3-3, Nakamichi, Higashinari-ku, Osaka, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Yasuhiro Tamaki
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Breast and Endocrine Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute	Familial Cancer Study Group
Institute
Department

Funding Source
Organization	Osaka Fundation for the prevention of cancer and cardiovascular diseases
Organization
Division
Category of Funding Organization	Non profit foundation
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	2013 Year 07 Month 12 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	Open public recruiting
Date of protocol fixation	2012 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date	2013 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 07 Month 12 Day
Last modified on	2021 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013073