UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059530 |
|---|---|
| Receipt number | R000068090 |
| Scientific Title | The Clinical Impact of Universal Mismatch Repair Deficiency Screening in Elderly Patients with Resected Colorectal Cancer: A Single-Center, Retrospective Cohort Study |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/24 13:24:25 |
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Basic information
Public title
An investigation into the diagnostic value of screening all older colorectal cancer patients for defects in cancer's DNA repair function (MMR/MSI testing).
Acronym
DNA Repair Test for Older Colorectal Cancer
Scientific Title
The Clinical Impact of Universal Mismatch Repair Deficiency Screening in Elderly Patients with Resected Colorectal Cancer: A Single-Center, Retrospective Cohort Study
Scientific Title:Acronym
MSI Screening Impact in Elderly CRC
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the prevalence and clinicopathological characteristics of Mismatch Repair Deficiency (MMRd) in elderly patients who have undergone resection for colorectal cancer.
Basic objectives2
Others
Basic objectives -Others
1. To evaluate the implementation status and systematic challenges of universal MMRd screening in the elderly population.
2. To examine the impact of MLH1 deficiency status within the MMRd group on patient prognosis and the tumor immune microenvironment.
3. To assess the significance of MMRd status in guiding prognosis and therapeutic stratification for elderly colorectal cancer patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of Mismatch Repair Deficiency (MMRd) detection in elderly patients with resected colorectal cancer.
Key secondary outcomes
Implementation rate of universal MMRd screening and associated clinical/systematic factors.
Disease-Free Survival (DFS) and Overall Survival (OS) stratified by MMRd status and MLH1 deficiency status.
Immune cell infiltration within the Tumor Microenvironment (TME) in MLH1-deficient MMRd tumors.
Post-operative treatment strategies considered for elderly colorectal cancer patients, stratified by MMRd status.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosis and Treatment: Patients diagnosed with Colorectal Cancer (CRC) who underwent surgical or endoscopic resection at Asahikawa Medical University Hospital.
Required Test: Patients who have been assessed for high-frequency microsatellite instability (MSI-H) via either MSI testing or Mismatch Repair (MMR) protein Immunohistochemistry (IHC).
Age: Patients must have been 20 years of age or older at the time of diagnosis.
Observation Period: Patients who underwent surgery on or after January 1, 2013.
Exclusions: All stages, disease sites, and genders are included. (i.e., No restrictions on stage, site, or gender.)
Key exclusion criteria
Lack of Diagnostic Data: Cases where pathological tissue samples necessary for MMR/MSI status evaluation are unavailable or technically inadequate for testing.
Loss to Follow-up: Cases where prognosis data (DFS/OS) cannot be reliably traced, making primary outcome evaluation impossible.
Non-Adenocarcinoma: Cases with a pathological diagnosis other than adenocarcinoma (e.g., adenoma, carcinoid, GIST, lymphoma).
Non-Colorectal Origin: Cases where the primary tumor site is not colorectal (e.g., metastatic tumor from another organ).
Withdrawal of Consent: Cases where the patient or their proxy has formally withdrawn consent (opt-out) for the secondary use of their clinical data.
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Shonaka |
Organization
Asahikawa Medical University
Division name
Division of Gastrointestinal Surgery, Department of Surgery
Zip code
078-8510
Address
1-1, Midorigaokahigashi 2-jo, Asahikawa-shi, Hokkaido, Japan
TEL
0166-68-2503
shonaka@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Shonaka |
Organization
Asahikawa Medical University
Division name
Division of Gastrointestinal Surgery, Department of Surgery
Zip code
078-8510
Address
1-1, Midorigaokahigashi 2-jo, Asahikawa-shi, Hokkaido, Japan
TEL
0166-68-2503
Homepage URL
shonaka@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Akiyama Life Science Foundation.
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
Asahikawa Medical University Research Ethics Committee
Address
Asahikawa Medical University
Tel
0166-68-2187
rs-kk.g@asahikawa-med.ac.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
| 2025 | Year | 11 | 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
| 2024 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study aimed at elucidating the clinicopathological features of high microsatellite instability (MSI-H) colorectal cancer.
Subject Details: Colorectal cancer patients aged 20 years or older who underwent resection at Asahikawa Medical University between January 1, 2013, and March 31, 2026, and who received MSI or MMR protein testing (Target N=750).
Details of Observation:
Clinical data, including age, sex, TNM classification, pathological factors, driver gene mutations, surgical outcomes, adjuvant chemotherapy, recurrence, and prognosis, will be collected from medical records .
Pathological evaluation will be performed on surgical specimens and residual pathological samples. This includes special staining for tumor-local inflammatory cell infiltration and factors like TP53.
Following the estimation of the association with local inflammatory cells, mass spectrometry will be considered.
Recruitment: Recruitment of participants will not be conducted, as this is a retrospective study utilizing information from medical records
Management information
Registered date
| 2025 | Year | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068090
