UMIN-CTR Clinical Trial

Basic information
Public title	Cancer survival of male BRCA mutation carriers: systematic review and meta-analysis
Acronym	Cancer survival of male BRCA mutation carriers: systematic review and meta-analysis
Scientific Title	Cancer survival of male BRCA mutation carriers: systematic review and meta-analysis
Scientific Title:Acronym	Cancer survival of male BRCA mutation carriers: systematic review and meta-analysis
Region	Japan

Condition
Condition	male breast cancer, prostate cancer, pancreatic cancer, colon cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Breast surgery Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	BRCA1 and BRCA2 are large tumor suppressor genes located on chromosomes 17 and 13, respectively. These genes encode for proteins that maintain genomic stability through DNA repair and transcriptional regulation. BRCA mutation carriers have a greater lifetime risk of developing cancer-breast and ovarian carcinomas in particular, so Hereditary Breast and Ovarian Cancer (HBOC) are must be most reminded for all female BRCA mutation carriers. The protocol of breast cancer screening for female BRCA mutation carriers has been widely establishing. The National Comprehensive Cancer Network (NCCN) recommends that breast cancer surveillance starting at age 25 years by breast MR imaging and mammography. And the NCCN guidelines also recommend prophylactic mastectomy, chemoprevention for breast cancer and, risk-reducing salpingo-oophorectomy for ovarian cancer prevention. Furthermore, significant risk for male breast cancer, pancreatic cancer, prostate cancer, and colon cancers are serious problem for male BRCA mutation carriers. Along with the updated knowledge progressing in female BRCA mutation carriers, the evidence for adequate support for male BRCA mutation carriers must be keep discussed. male BRCA mutation carriers have a greater lifetime risk of developing male breast, prostate, pancreatic, and colon cancer . Poor discussion about cancer survival for Male BRCA carrier. Therefore, we designed this study to focus on males and evaluate findings for providing information on updated various cancer survivals for male BRCA mutation carriers.
Basic objectives2	Others
Basic objectives -Others	Systematic review and meta-analysis to compare the prognosis of male breast cancer, prostate cancer, pancreatic cancer, and colorectal cancer in male BRCA1 / 2 mutant carriers with non-mutant individuals
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparing the prognosis of male breast cancer, prostate cancer, pancreatic cancer, and colorectal cancer in male BRCA1 / 2 mutant carriers with non-mutant individuals
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	90 years-old >=
Gender	Male
Key inclusion criteria	The studies written in English literature searched with the keywords ,"cancer", "breast cancer", "prostate cancer", "pancreatic cancer", "male", "BRCA1", "BRCA2", "BRCA", "colon cancer", "prognosis", "survival" in PubMed, OVID MEDLINE, and Scopus database.
Key exclusion criteria	Review articles, case reports, commentaries, published conference abstracts, and letters were excluded.
Target sample size

Research contact person
Name of lead principal investigator	1st name Noriko Middle name Last name Goda
Organization	Hiroshima Asa city Hospital
Division name	Department of breast surgery
Zip code	731-0293
Address	2-1-1, Kabe minami, Asa kita Ku, hiroshima city, Hiroshima
TEL	082-815-5211
Email	yoshimuranoriko32@gmail.com

Public contact
Name of contact person	1st name Noriko Middle name Last name Goda
Organization	Hiroshima Asa city Hospital
Division name	Department of breast surgery
Zip code	731-0293
Address	hiroshima
TEL	082-815-5211
Homepage URL
Email	yoshimuranoriko32@gmail.com

Sponsor
Institute	Hiroshima Asa city Hospital
Institute
Department

Funding Source
Organization	Hiroshima Asa city Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Hiroshima Asa city Hospital
Address	2-1-1, Kabe minami, Asa kita Ku, hiroshima city, Hiroshima
Tel	0828155211
Email	yoshimuranoriko32@gmail.com

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	2021 Year 06 Month 21 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	Terminated
Date of protocol fixation	2020 Year 02 Month 20 Day
Date of IRB	2020 Year 03 Month 01 Day
Anticipated trial start date	2020 Year 03 Month 01 Day
Last follow-up date	2021 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	under review and analysis

Management information
Registered date	2021 Year 06 Month 20 Day
Last modified on	2021 Year 09 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050943