The All Adenomas study
| ISRCTN | ISRCTN15213649 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15213649 |
| Secondary identifying numbers | IA study: HTA 04/33/01; AA study: HTA 15/80/13 |
- Submission date
- 21/02/2017
- Registration date
- 15/03/2017
- Last edited
- 04/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
Bowel polyps are small, benign (harmless) growths found on the inner lining of the colon (end part of the large intestine) or rectum. They are not usually cancerous, however if they are found they should be removed as some will eventually turn into cancer if left untreated. People who have been found to have bowel polyps need to undergo surveillance to monitor their growth. Current UK guidelines for the surveillance of people found to have bowel polyps classify people into those who are at low, intermediate or high risk of developing bowel cancer in the future. This guideline was developed in 2002 and now needs to be re-examined. People with intermediate risk bowel polyps are currently recommended to have 3-yearly surveillance colonoscopy (test to look inside the intestine with a camera on a flexible tube). This is likely a good option for some people in the intermediate risk group, but it may not be the best option for others. The aim of this study is to evaluate the effectiveness of the current surveillance guidelines.
This study is being extended to assess surveillance in low-risk and high-risk bowel polyp groups. Under the current guidelines, people with low-risk bowel polyps are recommended either no surveillance or colonoscopy at 5 years. In contrast, people with high-risk polyps are recommended to have a colonoscopy at least every three years and maybe more frequently to begin with. The aim of this study is to assess the effectiveness of these guidelines; to understand whether it is safe for people within the low-risk group not to have a colonoscopy, and whether there are people within the high-risk group who do not require such intensive surveillance. The study also re-examines surveillance in the intermediate-risk group with longer follow-up.
Who can participate?
Men and women of any age who have bowel polyps who have had a colonoscopy
What does the study involve?
The study uses material from several high-quality databases in hospitals or from bowel cancer screening initiatives to identify groups of patients with bowel polyps. Information from routine colonoscopies conducted to the current surveillance programme is collected and used to see if patient’s polyps worsen or turn into cancer at later visits.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved for those participating.
Where is the study run from?
Cancer Screening and Prevention Research Group (UK)
When is the study starting and how long is it expected to run for?
September 2006 to July 2028
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Prof. Amanda Cross, amanda.cross@imperial.ac.uk
Contact information
Public
Room 1089
Department of Surgery and Cancer
Imperial College London
Queen Elizabeth The Queen Mother (QEQM) Building
St Mary’s Hospital
London
W2 1NY
United Kingdom
 ORCID ID |
0000-0002-0893-2377 |
|---|
Study information
| Study design | Retrospective observational multi-centre cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | No participant information sheet available |
| Scientific title | The clinical effectiveness of different surveillance strategies to prevent colorectal cancer in people with low-, intermediate-, or high-risk colorectal adenomas: a retrospective cohort analysis |
| Study hypothesis | Current hypothesis: The aim of this study is to review the long-term risk of CRC and surveillance requirements in all adenoma risk groups; assess heterogeneity in risk; identify appropriate surveillance intervals within defined risk groups; evaluate the psychological impact of surveillance, and the cost-effectiveness of alternative follow-up strategies. Previous hypothesis: The aim of this study is to examine the effect of surveillance on colorectal cancer (CRC) incidence; assess heterogeneity in risk; and identify the optimum frequency of surveillance, the psychological impact of surveillance, and the cost-effectiveness of alternative follow-up strategies. |
| Ethics approval(s) | NRES Committee London - Hampstead, 15/03/2006, ref: 06/Q0501/45 Amendment to include All Adenomas objectives, London - Hampstead Research Ethics Committee, 10/04/2017 |
| Condition | 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) |
| Intervention | Routinely reported UK hospital data on gastrointestinal endoscopy and pathology data are collected for consecutive patients having diagnostic and surveillance procedures to identify the study cohort (people with intermediate adenomas at a baseline visit). The same hospital dataset is used to determine the incidence of advanced adenomas or colorectal cancers at subsequent follow-up visits. The cohort is flagged to receive long-term follow-up data on bowel cancers and deaths from ONS and HSCIC. A second dataset is created from three independent screening studies (UKFSST, English Bowel Cancer Screening Pilot and Kaiser Permanente Colon Cancer Prevention Program). The same data coding rules used in the hospital data set are used in the screening data set to determine baseline and follow-up visits, and polyp and procedural characteristics. The incidence of advanced adenomas or colorectal cancers at subsequent follow-up visits is reported. Added 22/06/2017: For the All Adenomas study, routinely reported UK hospital data on gastrointestinal endoscopy and pathology data are collected for consecutive patients having diagnostic and surveillance procedures to identify the study cohort (people with adenomas at a baseline visit). Data on long-term CRC incidence and mortality, as well as CRC staging and pathology, are determined from NHS Digital, Office for National Statistics (ONS), NHS National Services Scotland (NHS NSS) and the Public Health England Office for Data Release (PHE-ODR). |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measures as of 22/06/2017: 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. Previous primary outcome measures: 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 | 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 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. |
| Overall study start date | 01/09/2006 |
| Overall study end date | 01/07/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 65,000 people with low-, intermediate or high-risk adenomas |
| Total final enrolment | 33011 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/08/2007 |
| Recruitment end date | 31/07/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Surgery and Cancer
Imperial College London
Queen Elizabeth The Queen Mother (QEQM) Building
St Mary’s Hospital
London
W2 1NY
United Kingdom
Sponsor information
University/education
Research Governance Manager
5th Floor, Sherfield Building
Imperial College London
Prince Consort Road
South Kensington
London
SW7 2BB
England
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The Intermediate Adenoma study results were published in Lancet Oncology in April 2017 (e-Pub). The corresponding NIHR Final Report was published in the Health Technology Assessment journal in June 2017. The NIHR Final Report of the All Adenomas Study will also be published by the NIHR Journals Library and the plan is to publish the study results in a high-impact journal in 2018. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2017 | Yes | No | |
| Results article | results | 01/06/2017 | Yes | No | |
| Abstract results | Abstracts of the BSG Campus 2021 | 21/01/2021 | 05/05/2022 | No | No |
| Other publications | colorectal cancer incidence in 3-yearly surveillance post-polypectomy | 19/08/2020 | 05/05/2022 | Yes | No |
| Results article | Long-term colorectal cancer incidence results | 17/01/2020 | 05/05/2022 | Yes | No |
| Results article | Principles for Evaluation of Surveillance After Removal of Colorectal Polyps | 30/03/2020 | 05/05/2022 | Yes | No |
| Results article | adenoma characteristics associated with proximal colon cancer | 11/02/2022 | 05/05/2022 | Yes | No |
| Results article | evaluation of the 2020 UK post-polypectomy surveillance guidelines | 05/03/2021 | 05/05/2022 | Yes | No |
| Results article | optimal surveillance intervals for advanced neoplasia detection rates | 11/04/2022 | 05/05/2022 | Yes | No |
| Results article | post-polypectomy and post-colorectal cancer resection surveillance guidelines | 27/11/2019 | 05/05/2022 | Yes | No |
| Results article | publication on the necessity of surveillance colonoscopy for patients with bowel polyps | 15/05/2020 | 05/05/2022 | Yes | No |
| Funder report results | results and plain language summary in Health Technology Assessment | 01/05/2022 | 08/06/2022 | Yes | No |
Editorial Notes
04/07/2024: The contact and sponsor address details were updated.
16/06/2023: The following changes have been made:
1. The overall trial end date has been changed from 30/06/2023 to 01/07/2028 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 30/06/2024 to 01/07/2029.
05/12/2022: The following changes have been made:
1. The IPD sharing summary has been changed from "Data sharing statement to be made available at a later date" to "Not expected to be made available".
2. The overall trial end date has been changed from 31/12/2022 to 30/06/2023 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 31/12/2019 to 30/06/2024.
08/06/2022: Publication reference added.
05/05/2022: The following changes have been made:
1. Publication references added.
2. The total final enrolment number has been added.
13/03/2020: Internal review.
13/02/2019: The following changes were made to the trial record:
1. The public title was changed from 'Frequency of follow-up for patients with low-, intermediate- and high-risk colorectal adenomas' to 'The All Adenomas study'
2. The plain English summary was updated.
3. The overall end date was changed from 31/08/2018 to 31/12/2022.
4. The study contact was changed.
5. The intention to publish date was changed from 31/12/2018 to 31/12/2019.
22/06/2017: The following changes were made to the trial record:
1. The public title was changed from 'Frequency of follow-up for patients with intermediate-grade colorectal adenomas' to 'Frequency of follow-up for patients with low-, intermediate- and high-risk colorectal adenomas'.
2. The scientific title was changed from 'The clinical effectiveness of different surveillance strategies to prevent colorectal cancer in people with intermediate-grade colorectal adenomas: a retrospective cohort analysis' to 'The clinical effectiveness of different surveillance strategies to prevent colorectal cancer in people with low-, intermediate-, or high- risk colorectal adenomas: a retrospective cohort analysis'.
3. The condition was changed from 'Patients with intermediate-risk adenoma(s) (three or four small adenomas or one or two large adenomas)' to '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), high-risk adenoma(s) (five or more small adenomas, or three or more large adenomas)'
4. The overall trial end date was changed from 31/12/2017 to 31/08/2018.
5. The target number of participants was changed from '10,000 people with intermediate risk adenomas' to '65,000 people with low-, intermediate or high-risk adenomas'.
6. Publication references added.
