The All Adenomas study

Not Applicable

• Conditions: Patients diagnosed with adenomas at colonoscopy, including those with low-risk adenoma(s) (one or two small adenomas), intermediate-risk adenoma(s) (three or four small adenomas, or one or two large adenomas) or high-risk adenoma(s) (five or more small adenomas, or three or more large adenomas); Cancer; Adenoma

• Registration Number: ISRCTN15213649
• Lead Sponsor: Imperial College London

Brief Summary

2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28621643 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28457708 results 2021 Abstract results in http://dx.doi.org/10.1136/gutjnl-2020-bsgcampus.56 Abstracts of the BSG Campus 2021 (added 05/05/2022) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32814350/ colorectal cancer incidence in 3-yearly surveillance post-polypectomy (added 05/05/2022) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/31953252/ Long-term colorectal cancer incidence results (added 05/05/2022) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32240700/ Principles for Evaluation of Surveillance After Removal of Colorectal Polyps (added 05/05/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35149853/ adenoma characteristics associated with proximal colon cancer (added 05/05/2022) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33674342/ evaluation of the 2020 UK post-polypectomy surveillance guidelines (added 05/05/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35405762/ optimal surveillance intervals for advanced neoplasia detection rates (added 05/05/2022) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31776230/ post-polypectomy and post-colorectal cancer resection surveillance guidelines (added 05/05/2022) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32414779/ publication on the necessity of surveillance colonoscopy for patients with bowel polyps (added 05/05/2022) 2022 Funder report results in https://pubmed.ncbi.nlm.nih.gov/35635015/ results and plain language summary in Health Technology Assessment (added 08/06/2022)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-15
• Last Update Posted: 15 July 2024
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 33011

Inclusion Criteria

Current inclusion criteria as of 22/06/2017:
1. Men and women
2. Any age
3. With low-, intermediate- or high-risk adenomas who have undergone a baseline colonoscopy

Previous inclusion criteria:
1. Men and women
2. Any age
3. With intermediate adenomas who have undergone a baseline colonoscopy

Exclusion Criteria

1. Any of the following diagnoses at, or prior to, baseline:
1.1. CRC or inflammatory bowel disease (IBD)
1.2. Resection/anastomosis
1.3. Volvulus
2. Any of the following diagnoses at any time:
2.1. Family history of familial adenomatous polyposis (FAP)
2.2. HNPCC
2.3. Cowden syndrome
2.4. Juvenile or hamartomatous polyps
3. Patients with polyposis could be excluded depending on polyposis type and time of diagnosis
4. No baseline colonoscopy
5. One or more procedures without a date
6. More than 40 endoscopic procedures recorded

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 22/06/2017:<br>Incidence of adenomas, advanced adenomas and colorectal cancer (CRC) at follow-up visits will be measured through medical record review. Long-term CRC incidence will be determined from ONS / NHS Digital / NHS NSS and PHE-ODR data.<br><br>Previous primary outcome measures:<br>Incidence of adenomas, advanced adenomas and colorectal cancer (CRC) at follow-up visits will be measured through medical record review and long-term CRC incidence will be determined from ONS/HSCIC data.

Secondary Outcome Measures

Name	Time	Method
1. Psychological impact (anxiety, bowel cancer worry, number of GP visits and bowel symptoms) was measured using a questionnaire sent to participants who took part in the UKFSST screening study 6-months before screening and 3-6 months after screening<br>2. The health-economic analysis will take the form of an incremental cost-effective analysis of intermediate risk patients in the hospital data set, using a state-transition model. Two key health economic outcomes will be reported – cost per cancer avoided and cost per life year saved.