Lynch SyndromeNCT06126120
Colonoscopy Check-up in People With Lynch Syndrome
An observational study of Lynch Syndrome, run by Imperial College London at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Lynch Syndrome
- How many people
- 231 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jan 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study included people who were in the Lynch syndrome research registry pilot and who met the eligibility criteria for the present study.
Who may be able to join
- People in the Lynch syndrome research registry pilot who provided consent to be contacted about future research and were aged ≥25 years
Who cannot join
- People who had undergone surgery involving removal of their rectum
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
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, W2 1NY
About this study
Official title: Prevalence, Determinants, and Challenges of Adherence With Colonoscopy Check-up in People With Lynch Syndrome: a Questionnaire-based Study
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 investigated the:
Read more
- percentage who underwent 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 undergoing colonoscopy check-up
This study collected information from people in the 'Lynch syndrome research registry pilot' using a questionnaire. The Cancer Screening and Prevention Research Group (CSPRG) at Imperial College London set up the Lynch syndrome research registry pilot, which included adults with Lynch syndrome who had previously participated in the Cancer Prevention Programme 3 (CaPP3) trial.
The present study included people who took part in the Lynch syndrome research registry pilot, provided consent to be contacted about future research, and were aged ≥25 years. People who had undergone surgery to remove their rectum were excluded.
The investigators used 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 research registry pilot.
Participation involved completing the questionnaire only. The study was completed over approximately one year from administering the questionnaire in January 2024 to sharing results with participants in December 2024.
- Conditions
- Lynch Syndrome
- Keywords
- Lynch Syndrome, Colonoscopy, Surveillance
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Non-adherence to 2-yearly Colonoscopy Check-up.
Participant non-adherence to 2-yearly colonoscopy check-up was assessed using data from the national Hospital Episode Statistics (HES) database. Non-adherence was calculated based on the interval(s) between participants' 2 or 3 most recent check-up colonoscopies, depending on data availability, and the interval between participants' most recent check-up colonoscopy and questionnaire completion. Colonoscopy data recorded between December 1995 (when the earliest colonoscopy was recorded in the HES extract) and April 2024 (the final month in which participants completed the questionnaire) were used. Participant non-adherence was reported as a percentage.
Measured: Up to approximately 13 years (median 5 years), based on the interval(s) between participants' 2 or 3 most recent check-up colonoscopies and the interval between participants' most recent check-up colonoscopy and questionnaire completion.
Secondary outcomes (1)
The 4 Most Important Challenges to Having Colonoscopy Check-up for Participants.
The 4 most important challenges to having colonoscopy check-up were identified using participants' responses in the questionnaire. The questionnaire asked participants to select up to 4 challenges they considered most important from a given list of 41 challenges. The 4 challenges most frequently selected by participants were considered the most important. The results show, for each challenge, the number and proportion of participants who selected it as one of their biggest challenges. As participants could select more than one challenge, the counts and percentages for individual challenges do not sum to the total number of participants and 100%, respectively.
Measured: At time of questionnaire (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start17 Jan 2024
- Primary completion4 Apr 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda J Cross, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126120
- Sponsor's protocol ID
- IRAS 329468
- Status last verified
- May 2026
- First submitted
- 3 Nov 2023
- Last updated
- 5 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Determinants, and Challenges of Adherence With Colonoscopy Check-up in People With Lynch Syndrome: a Questionnaire-based Study
- ClinicalTrials.gov ID
- NCT06126120
- Acronym / sponsor ID
- IRAS 329468
- Conditions
- Lynch Syndrome
- Keywords
- Lynch Syndrome, Colonoscopy, Surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Posted 5 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 investigated the:
- percentage who underwent 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 undergoing colonoscopy check-up
This study collected information from people in the 'Lynch syndrome research registry pilot' using a questionnaire. The Cancer Screening and Prevention Research Group (CSPRG) at Imperial College London set up the Lynch syndrome research registry pilot, which included adults with Lynch syndrome who had previously participated in the Cancer Prevention Programme 3 (CaPP3) trial.
The present study included people who took part in the Lynch syndrome research registry pilot, provided consent to be contacted about future research, and were aged ≥25 years. People who had undergone surgery to remove their rectum were excluded.
The investigators used 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 research registry pilot.
Participation involved completing the questionnaire only. The study was completed over approximately one year from administering the questionnaire in January 2024 to sharing results with participants in December 2024.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included people who were in the Lynch syndrome research registry pilot and who met the eligibility criteria for the present study.
Key inclusion criteria (1 listed)
- People in the Lynch syndrome research registry pilot who provided consent to be contacted about future research and were aged ≥25 years
Key exclusion criteria (1 listed)
- People who had undergone surgery involving removal of their rectum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participant Non-adherence to 2-yearly Colonoscopy Check-up.
Time frame: Up to approximately 13 years (median 5 years), based on the interval(s) between participants' 2 or 3 most recent check-up colonoscopies and the interval between participants' most recent check-up colonoscopy and questionnaire completion.
Participant non-adherence to 2-yearly colonoscopy check-up was assessed using data from the national Hospital Episode Statistics (HES) database. Non-adherence was calculated based on the interval(s) between participants' 2 or 3 most recent check-up colonoscopies, depending on data availability, and the interval between participants' most recent check-up colonoscopy and questionnaire completion. Colonoscopy data recorded between December 1995 (when the earliest colonoscopy was recorded in the HES extract) and April 2024 (the final month in which participants completed the questionnaire) were used. Participant non-adherence was reported as a percentage.
1 secondary outcome
The 4 Most Important Challenges to Having Colonoscopy Check-up for Participants.
Time frame: At time of questionnaire (1 day)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Lynch Syndrome
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FITting Non-invasive Tests in Lynch Syndrome Surveillance
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Active, not recruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda J Cross, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lynch Syndrome, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Non-adherence to 2-yearly Colonoscopy Check-up. (time frame: Up to approximately 13 years (median 5 years), based on the interval(s) between participants' 2 or 3 most recent check-up colonoscopies and the interval between participants' most recent check-up colonoscopy and questionnaire completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.