The Study of Adenoma Characteristics of the COX-2 and DNMT Expressions in the Index Colonoscopy to Predict the Polyp Recurrence During Surveillance

Sponsor
National Cheng-Kung University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05568810
Collaborator
(none)
831
24

Study Details

Study Description

Brief Summary

The colorectal cancer is the first incidence and ranks the third cancer-death cause in Taiwan. Based on the Taiwan-national colon cancer screening program, early colorectal cancer detection rate and the survival are markedly improved. Besides to disclose the early cancer, there are vast populations to be disclosed with colon adenoma. Some of colon adenoma really presents as advanced colon adenoma (ACA) to carry higher risk of recurrence and even cancer progression. The current clinical guidelines raise strategy for colonoscopy surveillance based on the results of the index colonoscopy to categorize the patients into different risks of colon polyp recurrence and early detection of colorectal cancer. It is worthy to validate whether the real scenario of Taiwan colonoscopy surveillance can fulfill the guidelines worldwide. Furthermore, it shall be of clinical importance to elucidate out the high risky group who may be commonly disclosed during intense colonoscopy surveillance and to disclose with advanced adenoma. Accordingly, the domestic amending to the worldwide guideline shall be in need and need a more reliable biomarker to predict the recurrence of colon adenoma during surveillance colonoscopy. Concerning, cyclooxygenase-2 (COX-2) and DNA methyltransferases (DNMT) are involved during colorectal carcinogenesis via chronic inflammatory process and early tumorigenesis. This study proposes COX-2 and DNMT shall be potential biomarkers correlating to the recurrence of colon adenoma disclosed during surveillance colonoscopy in Taiwan. We thus conduct a prospective study, containing at least 1,400 cases, who will undergo surveillance colonoscopy in National Cheng Kung University Hospital in the next year. The study shall be a large-case study to answer whether the surveillance interval of the surveillance colonoscopy can be fulfilled to the suggestion of the 2012 United States Multi-society Task Force (USMTF) on colorectal cancer guideline. Factors that affect the detection of polyps in the surveillance will be explored. Based on the invitation of the patients to receive surveillance colonoscopy, the study also test whether COX-2 or DNMT over-expression are markers to predict polyps recurrence and to identify the risky patient deserve for earlier colonoscopy.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    831 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Study of Adenoma Characteristics of the COX-2 and DNMT Expressions in the Index Colonoscopy to Predict the Polyp Recurrence During Surveillance
    Actual Study Start Date :
    Aug 1, 2014
    Actual Primary Completion Date :
    Jul 31, 2016
    Actual Study Completion Date :
    Jul 31, 2016

    Outcome Measures

    Primary Outcome Measures

    1. the compatibility of surveillance colonoscopy with the USMTF guideline in Taiwan [usual the exam of colonoscopy: 10 min to 60 min]

      To determine the compatibility of surveillance colonoscopy with the USMTF guideline for different histological features of colon adenoma at index colonoscopy in Taiwan

    2. Factors that affect the detection of polyps in the surveillance [usual the exam of colonoscopy: 10 min to 60 min]

      To explore factors that affect the detection of polyps in the surveillance

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Patients who receive surveillance colonoscopy during the study period at National Cheng Kung University Hospital, a tertiary referral medical center in Taiwan, are enrolled in the study
    Exclusion Criteria:
    • poor bowel preparation, failed cecal intubation, contraindication for biopsy or polypectomy, patients with a history of inflammatory bowel disease, and those who are under 18 years old, decline to join the study, or do not have previous colonoscopy conducted in our institute

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Cheng-Kung University Hospital

    Investigators

    • Principal Investigator: Wei-Ying Chen, MD, National Cheng-Kung University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cheng-Kung University Hospital
    ClinicalTrials.gov Identifier:
    NCT05568810
    Other Study ID Numbers:
    • A-ER-102-436
    First Posted:
    Oct 6, 2022
    Last Update Posted:
    Oct 6, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Cheng-Kung University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2022