Comparison of Expression of Carcinogenesis-related Molecular Markers in the Patients With Colon Cancer and Polyp
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|ClinicalTrials.gov Identifier: NCT05638542|
Recruitment Status : Active, not recruiting
First Posted : December 6, 2022
Last Update Posted : December 6, 2022
|Condition or disease|
|Colorectal Cancer Colorectal Adenoma|
|Study Type :||Observational|
|Actual Enrollment :||582 participants|
|Official Title:||Comparison of Expression of Carcinogenesis-related Molecular Markers in the Patients With Colon Cancer and Polyp|
|Actual Study Start Date :||March 1, 2015|
|Actual Primary Completion Date :||January 30, 2021|
|Estimated Study Completion Date :||December 2023|
Patients who are not diagnosed with colorectal adenoma or colorectal cancer
Colorectal adenoma group
Patients who are diagnosed with colorectal adenoma
Colorectal cancer group
Patients who are diagnosed with colorectal cancer
- The characteristics of carcinogenesis-related molecular markers in colorectal adenoma and CRC [ Time Frame: through study completion, an average of 1 year ]
Using endoscopically biopsied specimens, multiple carcinogenic markers were investigated including KRAS and BRAF mutation, PD-L1, EGFR, IL-1b, NLRP3, Caspase-1, p53 expression, Microinstability (MSS, MSI-L, MSI-H), PD-L1, DNA mismatch repair proteins (MLH1, MSH2, MSH6, PMS2), CIMP markers (p16, MINT1, MINT2, MINT31, hMLH1), promoter methylation of p16, RUNX3, NEUROG1.
CIMP was assessed by methylation-specific PCR for five methylation panel markers (p16, MINT1, MINT2, MINT31, hMLH1), and MSI status was validated by PCR using five NCI markers (BAT-26, BAT-25, D5S346, D17S250, and S2S123). KRAS and BRAF mutation was analyzed by direct sequencing using sequence-specific primers from the acquired biopsy specimens. PD-L1, EGFR, MMR expression was examined using immunohistochemistry.
- Fecal microbiota analysis in patients with colorectal adenoma and CRC [ Time Frame: through study completion, an average of 1 year ]Using next-generation sequencing technique, fecal microbiota of patients with colorectal adenoma and CRC as well as healthy control was evaluated to verify carcinogenesis-related microbiota.
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05638542
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707|
|Study Chair:||Nayoung Kim, M.D., Ph.D||Seoul National University Bundang Hospital|