Colorectal CancerCADNCT05963724
Real-Time CAD for Colonic Neoplasia: A RCT
A study testing Real-Time Computer Aided Detection and Stanford Colonoscopy in people with Colorectal Cancer and Colorectal Neoplasms, run by Riverside University Health System Medical Center at 1 site in United States.
Trial summary
This study assesses the sensitivity and added benefits of computer-aided detection compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy. Read more about this study
- Who is it for?
- Ages 30 to 100 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms
- What is being tested?
- Real-Time Computer Aided Detection and Stanford Colonoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 27 May 2023
- 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 30 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing colonoscopy at RUHS
- Age > 45 years
- No contraindications to colonoscopy
Who cannot join
- Prior history of subtotal colectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Riverside University Health System
Moreno Valley, California, 92555
About this study
Official title: Efficacy of Real-Time Computer Aided-Detected of Colonic Neoplasia in an Underserved Population, A Randomized Controlled Trial
This study assesses the sensitivity and added benefits of computer-aided detection compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.
Read the detailed description
Failure in polyp detection leads to colon cancer after colonoscopy. Artificial intelligence systems allow real-time computer-aided detection of polyps with high-accuracy. This study will compare GI-Genius, a real-time CAD system to standard colonoscopy in terms of how many colonoscopies detect an adenoma.
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- Being tested
- Real-Time Computer Aided Detection, Stanford Colonoscopy
- Keywords
- artificial intelligence
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time Computer Aided DetectionDevice
This intervention involves using computer-aided detection using a real-time system (GI-Genius, Medtronic)
Stanford ColonoscopyProcedure or surgery
This involves white-light colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Real-Time Computer Aided Detection | Experimental | Not described Receives: Device: Real-Time Computer Aided Detection |
| Standard Colonoscopy | Active comparator | Not described Receives: Procedure: Stanford Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate
Measured: 1 year
Secondary outcomes (5)
Adenomas Per Colon
Measured: 1 year
Sessile Serrated Lesion Detection Rate
Measured: 1 year
Sessile Serrated Lesions Per Colon
Measured: 1 year
False Neoplasia Rate
Measured: 1 year
Withdrawal Time
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Sep 2022
- Primary completion31 Mar 2023
- Study completion27 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riverside University Health System Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963724
- Sponsor's protocol ID
- 1922564-2
- Acronym
- CAD
- Status last verified
- Jul 2023
- First submitted
- 19 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Thiruvengadam NR, Cote GA, Gupta S, Rodrigues M, Schneider Y, Arain MA, Solaimani P, Serrao S, Kochman ML, Saumoy M. An Evaluation of Critical Factors for the Cost-Effectiveness of Real-Time Computer-Aided Detection: Sensitivity and Threshold Analyses Using a Microsimulation Model. Gastroenterology. 2023 May;164(6):906-920. doi: 10.1053/j.gastro.2023.01.027. Epub 2023 Feb 2.
PubMed 36736437Thiruvengadam NR, Solaimani P, Shrestha M, Buller S, Carson R, Reyes-Garcia B, Gnass RD, Wang B, Albasha N, Leonor P, Saumoy M, Coimbra R, Tabuenca A, Srikureja W, Serrao S. The Efficacy of Real-time Computer-aided Detection of Colonic Neoplasia in Community Practice: A Pragmatic Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2024 Nov;22(11):2221-2230.e15. doi: 10.1016/j.cgh.2024.02.021. Epub 2024 Mar 2.
PubMed 38437999
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Real-Time Computer Aided-Detected of Colonic Neoplasia in an Underserved Population, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05963724
- Acronym / sponsor ID
- CAD / 1922564-2
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- Keywords
- artificial intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Riverside University Health System Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 27 May 2023 (actual)
- First posted
- 27 Jul 2023 (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.
This study assesses the sensitivity and added benefits of computer-aided detection compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.
Detailed description
Failure in polyp detection leads to colon cancer after colonoscopy. Artificial intelligence systems allow real-time computer-aided detection of polyps with high-accuracy. This study will compare GI-Genius, a real-time CAD system to standard colonoscopy in terms of how many colonoscopies detect an adenoma.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-Time Computer Aided Detection | Experimental | Device: Real-Time Computer Aided Detection |
| Standard Colonoscopy | Active comparator | Procedure: Stanford Colonoscopy |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing colonoscopy at RUHS
- Age > 45 years
- No contraindications to colonoscopy
Key exclusion criteria (1 listed)
- Prior history of subtotal colectomy
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 |
|---|---|---|
| Real-Time Computer Aided DetectionThis intervention involves using computer-aided detection using a real-time system (GI-Genius, Medtronic) | Device | Real-Time Computer Aided Detection |
| Stanford ColonoscopyThis involves white-light colonoscopy | Procedure or surgery | Standard Colonoscopy |
Primary outcome
Adenoma Detection Rate
Time frame: 1 year
5 secondary outcomes
Adenomas Per Colon
Time frame: 1 year
Sessile Serrated Lesion Detection Rate
Time frame: 1 year
Sessile Serrated Lesions Per Colon
Time frame: 1 year
False Neoplasia Rate
Time frame: 1 year
Withdrawal Time
Time frame: 1 year
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 27 Jul 2023.
- Background: PubMed 36736437Thiruvengadam NR, Cote GA, Gupta S, Rodrigues M, Schneider Y, Arain MA, Solaimani P, Serrao S, Kochman ML, Saumoy M. An Evaluation of Critical Factors for the Cost-Effectiveness of Real-Time Computer-Aided Detection: Sensitivity and Threshold Analyses Using a Microsimulation Model. Gastroenterology. 2023 May;164(6):906-920. doi: 10.1053/j.gastro.2023.01.027. Epub 2023 Feb 2.
- Derived from this study: PubMed 38437999Thiruvengadam NR, Solaimani P, Shrestha M, Buller S, Carson R, Reyes-Garcia B, Gnass RD, Wang B, Albasha N, Leonor P, Saumoy M, Coimbra R, Tabuenca A, Srikureja W, Serrao S. The Efficacy of Real-time Computer-aided Detection of Colonic Neoplasia in Community Practice: A Pragmatic Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2024 Nov;22(11):2221-2230.e15. doi: 10.1016/j.cgh.2024.02.021. Epub 2024 Mar 2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-Time Computer Aided Detection and Stanford Colonoscopy in people with Colorectal Cancer and Colorectal Neoplasms, run by Riverside University Health System Medical Center 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 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 27 Jul 2023. 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 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?
Adenoma Detection Rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05963724, which also lists 2 linked publications.
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 27 Jul 2023.