Colorectal Cancer Clinical Trial
Official title:
Comparison of Expression of Carcinogenesis-related Molecular Markers in the Patients With Colon Cancer and Polyp
Verified date | April 2023 |
Source | Seoul National University Bundang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A study of carcinogenesis-related molecular markers in the patients with colorectal cancer and colorectal adenoma.
Status | Active, not recruiting |
Enrollment | 582 |
Est. completion date | December 2023 |
Est. primary completion date | January 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Control group: subjects with no evidence of colorectal adenoma or colorectal cancer - Colorectal adenoma group: Patients with colorectal adenomas greater than or equal to 10 mm in diameter according to the endoscopic presentation as well as histological validation of colorectal adenoma. - Colorectal cancer group: Patients whose biopsy specimen is histologically confirmed as colorectal adenocarcinoma Exclusion Criteria: - Subjects age under 18 years - Previous history of colorectal neoplasms - Patients with high bleeding risk or patients who must maintain anti-coagulant or anti-platelet agents - Denial to participate in this study |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Bundang Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The characteristics of carcinogenesis-related molecular markers in colorectal adenoma and CRC | 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. |
through study completion, an average of 1 year | |
Primary | Fecal microbiota analysis in patients with colorectal adenoma and CRC | 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. | through study completion, an average of 1 year |
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