Colon CancerNCT05018325
Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy
A study testing Colonoscopy with 6 minute withdrawal, Colonoscopy 9 minute withdrawal and Colonoscopy 12 minute withdrawal in people with Colon Cancer and Rectal Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators' null hypothesis is that a withdrawal time of 9 to 10 minutes is non-inferior to a withdrawal time of 12 minutes or greater. Thus, the goal of this tandem design trial is to compare the additional diagnostic yield (# of missed lesions) for withdrawal times exceeding 10 minutes for… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Rectal Cancer, Colorectal Cancer
- What is being tested?
- Colonoscopy with 6 minute withdrawal, Colonoscopy 9 minute withdrawal and Colonoscopy 12 minute withdrawal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 19 Aug 2022
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be between the ages of 18 and 75 years
- Must be a patient undergoing screening or surveillance colonoscopy
- Must be able to understand and willing to sign an IRB-approved written informed consent document.
Who cannot join
- Inability to provide informed consent.
- Personal history of colorectal cancer (CRC)
- Personal history of colon surgery or colon resection
- Personal history of Inflammatory bowel disease
- Personal history of familial polyposis
- Current pregnancy
- Active GI bleeding
- Colonoscopy exams where the cecum cannot be reached (randomization will occur after cecum is reached).
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy: A Randomized Tandem Study
The investigators' null hypothesis is that a withdrawal time of 9 to 10 minutes is non-inferior to a withdrawal time of 12 minutes or greater. Thus, the goal of this tandem design trial is to compare the additional diagnostic yield (# of missed lesions) for withdrawal times exceeding 10 minutes for screening/surveillance colonoscopies. Although withdrawal times longer than the standard 6-minute recommendation have been shown to be beneficial, there is limited prospective evidence investigating the benefit or lack thereof for withdrawal times greater than 9-10 minutes.
- Conditions
- Colon Cancer, Rectal Cancer, Colorectal Cancer
- Being tested
- Colonoscopy with 6 minute withdrawal, Colonoscopy 9 minute withdrawal, Colonoscopy 12 minute withdrawal
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy with 6 minute withdrawalProcedure or surgery
Withdrawal time will be determined using a digital stopwatch by the nursing staff.
Colonoscopy 9 minute withdrawalProcedure or surgery
Withdrawal time will be determined using a digital stopwatch by the nursing staff.
Colonoscopy 12 minute withdrawalProcedure or surgery
Withdrawal time will be determined using a digital stopwatch by the nursing staff.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Colonoscopy 6 minute withdrawal time | Active comparator | -Undergo colonoscopy with the standard 6-minute withdrawal time followed by a tandem colonoscopy of at least another 6-minute withdrawal time. Receives: Procedure: Colonoscopy with 6 minute withdrawal |
| Arm 2: Colonoscopy 9 minute withdrawal time | Experimental | -Undergo a 9-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time. Receives: Procedure: Colonoscopy 9 minute withdrawal |
| Arm 3: Colonoscopy 12 minute withdrawal time | Experimental | -Undergo colonoscopy with a 12-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time Receives: Procedure: Colonoscopy 12 minute withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Miss rate of polyps
- Miss rate = missed polyps/missed polyps + polyps found during 1st exam
- Polyps is defined as adenomas and sessile serrated adenomas (SSA)
Measured: Time of colonoscopy (day 1)
Secondary outcomes (1)
Miss rate of advanced adenomas
- Miss rate = missed advanced adenomas/missed advanced adenomas + advanced adenomas found during 1st exam
- Advanced adenoma defined as a polyp ≥ 10mm, adenomas with high-grade dysplasia or villous architecture, serrated lesions with dysplasia, or traditional serrated adenomas
Measured: Time of colonoscopy (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start30 Aug 2021
- Primary completion19 Aug 2022
- Study completion19 Aug 2022
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vladimir Kushnir, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018325
- Sponsor's protocol ID
- 202103025
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2021
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underline the results reported, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy: A Randomized Tandem Study
- ClinicalTrials.gov ID
- NCT05018325
- Acronym / sponsor ID
- 202103025
- Conditions
- Colon Cancer, Rectal Cancer, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 24 Aug 2021 (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 investigators' null hypothesis is that a withdrawal time of 9 to 10 minutes is non-inferior to a withdrawal time of 12 minutes or greater. Thus, the goal of this tandem design trial is to compare the additional diagnostic yield (# of missed lesions) for withdrawal times exceeding 10 minutes for screening/surveillance colonoscopies. Although withdrawal times longer than the standard 6-minute recommendation have been shown to be beneficial, there is limited prospective evidence investigating the benefit or lack thereof for withdrawal times greater than 9-10 minutes.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Colonoscopy 6 minute withdrawal time | Active comparator | Procedure: Colonoscopy with 6 minute withdrawal-Undergo colonoscopy with the standard 6-minute withdrawal time followed by a tandem colonoscopy of at least another 6-minute withdrawal time. |
| Arm 2: Colonoscopy 9 minute withdrawal time | Experimental | Procedure: Colonoscopy 9 minute withdrawal-Undergo a 9-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time. |
| Arm 3: Colonoscopy 12 minute withdrawal time | Experimental | Procedure: Colonoscopy 12 minute withdrawal-Undergo colonoscopy with a 12-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be between the ages of 18 and 75 years
- Must be a patient undergoing screening or surveillance colonoscopy
- Must be able to understand and willing to sign an IRB-approved written informed consent document.
Key exclusion criteria (8 listed)
- Inability to provide informed consent.
- Personal history of colorectal cancer (CRC)
- Personal history of colon surgery or colon resection
- Personal history of Inflammatory bowel disease
- Personal history of familial polyposis
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 |
|---|---|---|
| Colonoscopy with 6 minute withdrawalWithdrawal time will be determined using a digital stopwatch by the nursing staff. | Procedure or surgery | Arm 1: Colonoscopy 6 minute withdrawal time |
| Colonoscopy 9 minute withdrawalWithdrawal time will be determined using a digital stopwatch by the nursing staff. | Procedure or surgery | Arm 2: Colonoscopy 9 minute withdrawal time |
| Colonoscopy 12 minute withdrawalWithdrawal time will be determined using a digital stopwatch by the nursing staff. | Procedure or surgery | Arm 3: Colonoscopy 12 minute withdrawal time |
Primary outcome
Miss rate of polyps
Time frame: Time of colonoscopy (day 1)
* Miss rate = missed polyps/missed polyps + polyps found during 1st exam * Polyps is defined as adenomas and sessile serrated adenomas (SSA)
1 secondary outcome
Miss rate of advanced adenomas
Time frame: Time of colonoscopy (day 1)
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underline the results reported, after deidentification.
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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.
Vladimir Kushnir, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy with 6 minute withdrawal, Colonoscopy 9 minute withdrawal and Colonoscopy 12 minute withdrawal in people with Colon Cancer and Rectal Cancer, run by Washington University School of Medicine at 1 site in United States.
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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 31 Aug 2022. 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 United States. 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 was stopped early (reason given: Futility). Results are not available in the source record.
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?
Miss rate of polyps (time frame: Time of colonoscopy (day 1)). 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 31 Aug 2022.