Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059530) titled 'An investigation into the diagnostic value of screening all older colorectal cancer patients for defects in cancer's DNA repair function (MMR/MSI testing)' on Nov. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Asahikawa Medical University
Condition:
Condition - Colorectal Cancer
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
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
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Withdrawal of Consent: Cases where the patient or their proxy has formally withdrawn consent (opt-out) for the secondary use of their clinical data.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 Size - 750
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068090
Disclaimer: Curated by HT Syndication.