UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050759 |
|---|---|
| Receipt number | R000057791 |
| Scientific Title | Screening study of mismatch repair (MMR) protein and BRAF mutant protein for rectal cancer |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2024/11/15 18:08:41 |
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Basic information
Public title
Screening study of mismatch repair (MMR) protein and BRAF mutant protein for rectal cancer
Acronym
R-MMR research
Scientific Title
Screening study of mismatch repair (MMR) protein and BRAF mutant protein for rectal cancer
Scientific Title:Acronym
R-MMR research
Region
| Japan |
Condition
Condition
Rectal cancer confirmed by histopathological diagnosis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We will acquire real-world data on the prevalence of mismatch repair (MMR) deficiency and BRAF V600E mutation in rectal cancer in Japan and clarify its frequency.
Basic objectives2
Others
Basic objectives -Others
When the dMMR detection kit (MLH1, PMS2, MSH2, MSH6), which is an IHC test, and the BRAF V600E mutation test, were tested for rectal cancer cases, (1) the frequency of dMMR, (2) each MMR protein (MLH1, PMS2 , MSH2, MSH6), and (3) the frequency of BRAF V600E mutation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of dMMR in rectal cancer specimens, loss of expression frequency of each MMR protein (MLH1, PMS2, MSH2, MSH6), frequency of BRAF V600E mutation
Key secondary outcomes
Associations between MMR, BRAF V600E mutation status and patient background factors
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Rectal cancer confirmed by histopathological diagnosis.
2) Age is 18 years or older.
3) IHC tests to detect MMR protein and tests to detect BRAF mutations (PCR test or IHC test) were performed in the clinical practice.
Key exclusion criteria
1)Cases judged to be unsuitable for enrollment in this study.
2)Patients who have requested that they do not wish to participate in the study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Gastrointestinal internal medicine
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Miyashita |
Organization
National Cancer Center Hospital East
Division name
Gastrointestinal internal medicine
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
yumiyash@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Roche Diagnostics K.K.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1,tsukiji,chuo-ku,Tokyo
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
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
| 2023 | Year | 05 | Month | 01 | 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
| 2022 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NONE
Management information
Registered date
| 2023 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057791
