UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044600 |
|---|---|
| Receipt number | R000050943 |
| Scientific Title | Cancer survival of male BRCA mutation carriers: systematic review and meta-analysis |
| Date of disclosure of the study information | 2021/06/21 |
| Last modified on | 2021/09/09 13:25:16 |
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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
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
yoshimuranoriko32@gmail.com
Sponsor or person
Institute
Hiroshima Asa city Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050943
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
