Colon PolypNCT05568810
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 of Colon Polyp, run by National Cheng-Kung University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colon Polyp
- How many people
- 831 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2014to 31 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Colon Polyp
- Keywords
- DNA methyltransferases (DNMT), cyclooxygenase-2 (COX-2)
- Medical subject headings
- Colonic Polyps
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: usual the exam of colonoscopy: 10 min to 60 min
Factors that affect the detection of polyps in the surveillance
To explore factors that affect the detection of polyps in the surveillance
Measured: usual the exam of colonoscopy: 10 min to 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Aug 2014
- Primary completion31 Jul 2016
- Study completion31 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PolypStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 831 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Ying Chen, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568810
- Sponsor's protocol ID
- A-ER-102-436
- Status last verified
- Sep 2022
- First submitted
- 3 Oct 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05568810
- Acronym / sponsor ID
- A-ER-102-436
- Conditions
- Colon Polyp
- Keywords
- DNA methyltransferases (DNMT), cyclooxygenase-2 (COX-2)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 831 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the compatibility of surveillance colonoscopy with the USMTF guideline in Taiwan
Time frame: 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
Factors that affect the detection of polyps in the surveillance
Time frame: usual the exam of colonoscopy: 10 min to 60 min
To explore factors that affect the detection of polyps in the surveillance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Ying Chen, MD principal investigator
National Cheng-Kung University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Polyp, run by National Cheng-Kung University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the compatibility of surveillance colonoscopy with the USMTF guideline in Taiwan (time frame: usual the exam of colonoscopy: 10 min to 60 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.