Implementation of Optical Diagnosis of Diminutive Colorectal Polyps: DISCARD3 Study (Incorporating AI-DETECT)

• Sponsor: London North West Healthcare NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT04710693
• Collaborator: (none)
• Enrollment: 614
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.6
• Patients Per Site Per Month: 28.4

Study Details

Study Description

Brief Summary

This is a prospective feasibility study. The aim of this work is to assess the acceptability and feasibility of optical diagnosis-led care in bowel cancer screening patients undergoing colonoscopy. This study will determine whether bowel cancer screening colonoscopists are able to consistently record and diagnose diminutive adenomas suitable for a resect and discard strategy allowing assignment of surveillance intervals according to Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) criteria. A practical quality assurance program around optical diagnosis will be introduced. The use of a CAD polyp-detection system will also be evaluated (AI-DETECT).

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyp	Diagnostic Test: CAD polyp-detection system	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 614 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Colonoscopy lists will be randomised for the use of a CAD polyp-detection system to be used as an adjunct to optical diagnosis. 50% of colonoscopy lists will be randomly assigned to use the CAD system and 50% of colonoscopy lists will not use the CAD system.Colonoscopy lists will be randomised for the use of a CAD polyp-detection system to be used as an adjunct to optical diagnosis. 50% of colonoscopy lists will be randomly assigned to use the CAD system and 50% of colonoscopy lists will not use the CAD system.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Implementation of Optical Diagnosis of Diminutive Colorectal Polyps in Real Life Clinical Practice: DISCARD3 Study (Incorporating AI-DETECT)
• Actual Study Start Date: Feb 14, 2020
• Actual Primary Completion Date: Dec 3, 2021
• Actual Study Completion Date: Dec 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: CAD polyp-detection system In this arm, a CAD polyp detection system will be used during the colonoscopy.	Diagnostic Test: CAD polyp-detection system; Software will be used during the procedure to aid the detection of polyps during the procedure.
No Intervention: Standard (no CAD polyp-detection system) In this arm, a CAD polyp detection system will not be used during the colonoscopy.

Outcome Measures

Primary Outcome Measures

1. Learning curve to achieve accurate optical diagnosis [Through study completion, approximately 18-24 months]

   The investigators will assess endoscopist learning curve by calculating percentage of accurate optical diagnoses of diminutive polyps (when compared with histopathology) for all endoscopists over the course of the study.

2. Proportion of cases where optical diagnosis derived surveillance intervals concur with histopathology derived surveillance intervals [2 weeks for each participant]

   For each participant, the surveillance interval according to international guidelines (UK, US, European) will be determined based on optical diagnoses alone and then separately based on histopathology results alone. The proportion of cases where both optical diagnosis derived and histopathology derived surveillance intervals agree will be calculated.

3. Polyp detection rate (AI-DETECT) [2 weeks for each participant]

   The investigators will assess the impact on polyp detection rate when using a CAD polyp-detection system.

Secondary Outcome Measures

1. Sensitivity of optical diagnosis [2 weeks for each participant]

   The sensitivity of optical diagnosis will be assessed for polyps identified during the course of the study.

2. Specificity of optical diagnosis [2 weeks for each participant]

   The specificity of optical diagnosis will be assessed for polyps identified during the course of the study.

3. Adenoma detection rate (AI-DETECT) [2 weeks for each participant]

   The investigators will assess the impact on adenoma detection rate when using a CAD polyp-detection system.

4. Serrated polyp detection rate (AI-DETECT) [2 weeks for each participant]

   The investigators will assess the impact on serrated polyp detection rate when using a CAD polyp-detection system.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients aged 60-74

• with +ve Faecal Occult Blood/Faecal Immunochemical test attending for screening colonoscopy within BCSP (Bowel Cancer Screening Programme)

• with an established history of adenomas attending for surveillance colonoscopy within BCSP

• Patients aged 55 - referred for screening colonoscopy following positive Bowel Scope Screening flexible sigmoidoscopy

Exclusion Criteria:

• Patients with a risk profile (due to family history or other) whose follow-up will be outside standard BCSP

• Patients with inflammatory bowel disease

• Unable to consent

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Mark's Hospital	Harrow		United Kingdom

Sponsors and Collaborators

• London North West Healthcare NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: London North West Healthcare NHS Trust
• ClinicalTrials.gov Identifier: NCT04710693
• Other Study ID Numbers: 245862
• First Posted: Jan 15, 2021
• Last Update Posted: Dec 22, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polyps; Colonic Polyps

Study Results

No Results Posted as of Dec 22, 2021