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CompletedNCT05568810Updated Oct 6, 2022

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

An observational study in Colon Polyp, sponsored by National Cheng-Kung University Hospital. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-10-06.

Sponsored by National Cheng-Kung University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
831
Ages
18 Years to 99 Years
Sex
All
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Study 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.

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Conditions studied

  • Colon Polyp

Keywords

  • DNA methyltransferases (DNMT)
  • cyclooxygenase-2 (COX-2)
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In context

Adenoma

657 studies on the registry are indexed under Adenoma; 98 are open to participants now.

This study's enrollment of 831 is above the median of 300 across 226 observational studies indexed under Adenoma.

Browse Adenoma studies →

Lead sponsor

National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
831 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. the compatibility of surveillance colonoscopy with the USMTF guideline in Taiwan

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

    Time frame: usual the exam of colonoscopy: 10 min to 60 min

  2. Factors that affect the detection of polyps in the surveillance

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

    Time frame: usual the exam of colonoscopy: 10 min to 60 min

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05568810
Lead sponsor
National Cheng-Kung University Hospital
Responsible party
Sponsor
First posted
Oct 6, 2022
Start date
Aug 1, 2014
Primary completion
Jul 31, 2016
Completion
Jul 31, 2016
Last update
Oct 6, 2022

Study contacts

Wei-Ying Chen, MD
principal investigator · National Cheng-Kung University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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