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| Name | Class |
|---|---|
| King's College London | OTHER |
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Surveillance for colorectal cancer (CRC) in patients predisposed to develop CRC during their lifetime has been impacted by access to colonoscopy suites and endoscopy specialists in the past couple of years. An alternative method, namely the colon capsule, has been proposed, however this investigation is time consuming for the clinician and the images require up to one hour (30-60 minutes) reading to issue a result. The investigators propose to obtain images from paired colonoscopies and colon capsules with the purpose of developing an AI algorithm which could aid the clinicians in reading the colon and expand access to this investigation.
The main aim of the study is to determine whether it is possible to obtain usable paired images from patients with Lynch and other cancer predisposition syndromes. This will depend on the willingness of the patients to take part in the study and the technical ability of obtaining data from paired images of colonoscopies and colon capsule.
At recruitment, participants will undergo a colon capsule investigation, followed by a routine colonoscopy as per their normal standard of care. Paired endoscopic images from colonoscopies and colon capsules will be collected and anonymised data will be accessed by the bioinformatician for analysis.
If the study will be successful in reaching the primary endpoint, further trials will be opened, allowing for a larger population to be included and to obtain more robust data, which eventually can lead to validated AI algorithms and application of computer-aided video-capsules examination as a screening tool in at-risk population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Videocapsule investigation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video capsule investigation | Device | Participants will undergo both a video capsule examination and a colonoscopy on the same day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of paired images the bioinformatician assesses as useful for the development of algorithm | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients at high-risk as defined by inclusion criteria who agree to undergo video capsule examination. | 18 months | |
| The proportion of patients who undergo both video capsule examination and colonoscopy, from whom it is possible to obtain paired images |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Cojocaru, MD | Contact | +44 20 7808 2603 | elena.cojocaru@nhs.net | |
| Lydia Taylor, RN | Contact | lydia.taylor@rmh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Richard Lee, PhD | Royal Marsden NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Marsden NHS Foundation Trust | Recruiting | London | (Select) | SW3 6JJ | United Kingdom |
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| 18 months |
| The description of any adverse events collected for the Pillcam procedure. | All adverse events will be collected using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | 18 months |
| ID | Term |
|---|---|
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| D016864 | Li-Fraumeni Syndrome |
| D006223 | Hamartoma Syndrome, Multiple |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006222 | Hamartoma |
| D009378 | Neoplasms, Multiple Primary |
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| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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