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NCT06126120 Clinical Trial

Colonoscopy Check-up in People With Lynch Syndrome

Lynch Syndrome Clinical Trial

Official title:
Prevalence, Determinants, and Challenges of Adherence With Colonoscopy Check-up in People With Lynch Syndrome: a Questionnaire-based Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06126120
Other study ID # IRAS 329468
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 17, 2024
Est. completion date December 2024

Study information
Verified date March 2024
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Lynch Syndrome, an inherited condition, increases bowel cancer risk. People with Lynch Syndrome are recommended to have regular colonoscopies where a camera in a tube is used to look inside the bowel for cancer and for polyps (growths that sometimes can become cancerous). UK guidelines recommend that people with Lynch Syndrome have colonoscopy check-up every 2 years after reaching a certain age; however, they face many challenges which make it difficult to have the recommended check-up. Among a subset of people with Lynch Syndrome in England, this study will investigate the: - percentage who are having colonoscopy check-up as recommended by UK guidelines - factors influencing whether a person is more/less likely to have the recommended colonoscopy check-up - views, experiences, and challenges of living with Lynch Syndrome and colonoscopy check-up This study will collect information from people in the 'Lynch Syndrome registry pilot' using a questionnaire. The Cancer Screening and Prevention Research Group (CSPRG) at Imperial College London are conducting the Lynch Syndrome registry pilot, which is recruiting people with Lynch Syndrome who are aged >18 years and in the Cancer Prevention Programme 3 (CaPP3) trial, from Nov 2022-Nov 2023. This study will include people in the Lynch Syndrome registry pilot who provided consent on the registry pilot consent form to be contacted about future research and are aged ≥25 years. People who have had previous surgery to remove their rectum will be excluded. The investigators will use the 'Views, experiences, and challenges of colonoscopy check-up' questionnaire, together with a few pieces of additional information previously collected as part of the Lynch Syndrome registry pilot. Participation involves completing the questionnaire only. The study will take approximately one year from administering the questionnaire to sharing results with participants.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 170
Est. completion date December 2024
Est. primary completion date April 3, 2024
Accepts healthy volunteers No
Gender All
Age group 25 Years and older
Eligibility Inclusion Criteria: - People in the Lynch Syndrome registry pilot who have provided consent to be contacted about future research and are aged =25 years Exclusion Criteria: - People who have had surgery involving removal of their rectum

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Cancer Screening and Prevention Research Group (CSPRG), Department of Surgery and Cancer, Queen Elizabeth The Queen Mother (QEQM) Building, St Mary's Hospital, Imperial College London London

Sponsors (1)
Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Participant non-adherence to 2-yearly colonoscopy check-up. Participant non-adherence to 2-yearly colonoscopy check-up will be assessed on a single occasion, considering participants' three most recent colonoscopy check-ups, measured as a percentage. 1 day
Secondary The four most important challenges to having colonoscopy check-up for participants. The four most important challenges to having colonoscopy check-up will be assessed on a single occasion, considering participants' responses in the questionnaire. The questionnaire asks participants to select their most important challenges from a given list, and the top four selections will be considered the most important challenges. 1 day
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