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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05638542
Other study ID # B-1305-203-009
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2015
Est. completion date December 2023

Study information

Verified date April 2023
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A study of carcinogenesis-related molecular markers in the patients with colorectal cancer and colorectal adenoma.


Description:

The chromosomal instability (CIN) pathway, the CpG island methylator phenotype (CIMP) pathway and the microsatellite instability (MSI) pathway are three major carcinogenesis pathways to colorectal cancer (CRC). In this study, the investigators aimed to investigate distinctive molecular features of carcinogenesis pathways among healthy control, colorectal adenoma, and CRC and compare their molecular progression according to patients' sex and tumor location as well as disease stage.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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