Condition category
Cancer
Date applied
21/02/2017
Date assigned
15/03/2017
Last edited
22/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 August 2018

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
1. Ms Paula Kirby (public)
p.kirby@imperial.ac.uk
2. Prof. Wendy Atkin
w.atkin@imperial.ac.uk

Trial website

http://www.csprg.org.uk/ia/

Contact information

Type

Public

Primary contact

Ms Paula Kirby

ORCID ID

Contact details

Cancer Screening and Prevention Research Group
Department of Surgery and Cancer
Imperial College London
St Mary’s Campus
Medical School Building
Norfolk Place
London
W2 1PG
United Kingdom

Type

Scientific

Additional contact

Prof Wendy Atkin

ORCID ID

http://orcid.org/0000-0001-9073-9658

Contact details

Cancer Screening and Prevention Research Group
Department of Surgery and Cancer
Imperial College London
St Mary’s Campus
Medical School Building
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)20 7594 3369 ext. 3350
w.atkin@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IA study: HTA 04/33/01; AA study: HTA 15/80/13

Study information

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

Acronym

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

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

Study design

Retrospective observational multi-centre cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

No participant information sheet available

Condition

Patients diagnosed with adenomas at colonoscopy, including those with:
1. Low-risk adenoma(s) (one or two small adenomas)
2. Intermediate-risk adenoma(s) (three or four small adenomas, or one or two large adenomas)
3. 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/09/2006

Overall trial end date

31/08/2018

Reason abandoned

Eligibility

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 type

Patient

Age group

All

Gender

Both

Target number of participants

65,000 people with low-, intermediate or high-risk adenomas

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

United Kingdom

Trial participating centre

Cancer Screening and Prevention Research Group
Rm 505 Wright Fleming Building Department of Surgery and Cancer Imperial College Norfolk Place
London
W2 1PG
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Research Governance Manager
Level 2
Medical School Building
Norfolk Place
London
W2 1PG
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

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.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28457708
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28621643

Publication citations

Additional files

Editorial Notes

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.