Colonic CancerNCT00280332
A Follow-up Colonoscopy Examination in Patients Who Had Previously Undergone Screening Colonoscopy
An observational study of Colonic Cancer, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
To determine the prevalence of colonic neoplasm in patients who had previously undergone screening colonoscopy To determine the optimal time interval for re-screening in average risk individuals To determine potential baseline characteristics that predicts adenoma recurrence Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Cancer
- What is being tested?
- colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 560 participants
- Where
- 1 siteChina
- Study dates
- Mar 2006to Nov 2007
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who are previously participated in one of our two screening colonoscopy studies [Sung, Gastroenterol 2003; Leung, AJG 2004]
Who may be able to join
- Subjects who are previously participated in one of our two screening colonoscopy studies [Sung, Gastroenterol 2003; Leung, AJG 2004]
- Asymptomatic on first screening colonoscopy
- Age>50and <75
- No family history of CRC
- No other colonoscopy except the baseline screening colonoscopy
Who cannot join
- Subjects who refused consent
- Subjects who are not warrant follow up colonoscopy
Trial locations and contacts
1 site in 1 country.
About this study
- To determine the prevalence of colonic neoplasm in patients who had previously undergone screening colonoscopy
- To determine the optimal time interval for re-screening in average risk individuals
- To determine potential baseline characteristics that predicts adenoma recurrence
Read the detailed description
Colorectal cancer (CRC) is the second commonest cancer in Hong Kong, and tends to be increasing. Screening for colorectal cancer can reduce the cancer incidence and mortality by detecting early lesions. However, the best interval for a follow up colonoscopy, particularly for those with normal baseline colonoscopy, remains largely unknown.
This study aim to determine the prevalence of colonic neoplasm in average-risk patients who had previously undergone screening colonoscopy and the optimal time interval for re-screening.
- Conditions
- Colonic Cancer
- Being tested
- colonoscopy
- Keywords
- colonic adenoma, colonic advanced neoplasm
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyProcedure or surgery
Also called follow up colonoscopy
proform a follow up colonoscopy in the 5 year period from index colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| A | colonic adenoma Receives: Procedure: colonoscopy | |
| B | colonic without adenoma Receives: Procedure: colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of advanced colonic adenoma in the re-screening population
Measured: 5 year from index colonoscopy
Secondary outcomes (1)
The time to adenoma adenoma development according to different baseline characteristics of patients and colonoscopy findings
Measured: 5 years from index colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2006 (estimated)
- Study startMar 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Wai K Leung, MD, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280332
- Sponsor's protocol ID
- FUC
- Status last verified
- May 2008
- First submitted
- 20 Jan 2006
- Last updated
- 12 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up Colonoscopy Examination in Patients Who Had Previously Undergone Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT00280332
- Acronym / sponsor ID
- FUC
- Conditions
- Colonic Cancer
- Keywords
- colonic adenoma, colonic advanced neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 23 Jan 2006 (estimated)
- 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.
- To determine the prevalence of colonic neoplasm in patients who had previously undergone screening colonoscopy
- To determine the optimal time interval for re-screening in average risk individuals
- To determine potential baseline characteristics that predicts adenoma recurrence
Detailed description
Colorectal cancer (CRC) is the second commonest cancer in Hong Kong, and tends to be increasing. Screening for colorectal cancer can reduce the cancer incidence and mortality by detecting early lesions. However, the best interval for a follow up colonoscopy, particularly for those with normal baseline colonoscopy, remains largely unknown.
This study aim to determine the prevalence of colonic neoplasm in average-risk patients who had previously undergone screening colonoscopy and the optimal time interval for re-screening.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Procedure: colonoscopycolonic adenoma |
| B | – | Procedure: colonoscopycolonic without adenoma |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are previously participated in one of our two screening colonoscopy studies [Sung, Gastroenterol 2003; Leung, AJG 2004]
Key inclusion criteria (5 listed)
- Subjects who are previously participated in one of our two screening colonoscopy studies [Sung, Gastroenterol 2003; Leung, AJG 2004]
- Asymptomatic on first screening colonoscopy
- Age>50and <75
- No family history of CRC
- No other colonoscopy except the baseline screening colonoscopy
Key exclusion criteria (2 listed)
- Subjects who refused consent
- Subjects who are not warrant follow up colonoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopyAlso: follow up colonoscopyproform a follow up colonoscopy in the 5 year period from index colonoscopy | Procedure or surgery | A, B |
Primary outcome
The prevalence of advanced colonic adenoma in the re-screening population
Time frame: 5 year from index colonoscopy
1 secondary outcome
The time to adenoma adenoma development according to different baseline characteristics of patients and colonoscopy findings
Time frame: 5 years from index colonoscopy
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 12 May 2008.
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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.
Wai K Leung, MD principal investigator
CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Cancer, run by Chinese University of Hong Kong at 1 site in China.
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 5 inclusion and 2 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 12 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 prevalence of advanced colonic adenoma in the re-screening population (time frame: 5 year from index colonoscopy). 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 12 May 2008.