NCT05064124 Early DiAgnosis Real-Time Healthcare System for CANcer Trial
| NCT ID | NCT05064124 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College, London |
| Condition | Polyps |
| Study Type | OBSERVATIONAL |
| Enrollment | 420 participants |
| Start Date | 2024-07-18 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 420 participants in total. It began in 2024-07-18 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to assess whether the AI characterisation system of the CADDIE device improves the endoscopists accuracy in the optical diagnosis of diminutive colorectal polyps in the bowel during colonoscopy. Participants will either have a colonoscopy with the assistance of the CADDIE device characterisation AI system ("intervention group") or have a colonoscopy in line with routine clinical practice i.e., without the CADDIE device characterisation AI system ("control group"). The randomisation method of this trial will allocate enrolled participants to the "intervention" group and to the "control" group by a technique similar to flipping a coin.
Eligibility Criteria
Inclusion Criteria: * Participants scheduled to undergo a screening, surveillance or symptomatic colonoscopy with an endoscopist participating in the study phase of the trial. * Male and female participants aged 18 years or older at the time of informed consent. * Participants able to comprehend, sign and date the written informed consent document to participate in the study. Exclusion Criteria: * Emergency and/or inpatient colonoscopies * Participants with inflammatory bowel disease (IBD) * Participants with current Colorectal Cancer (CRC) * Participants with a contraindication for biopsy or polypectomy. These include: * Participants who have not withheld medications pre-disposing to bleeding at time of colonoscopy as per local site /national guidelines. * Participants with a history of haemostasis disorders (haemostasis disorders will include but will not be limited to: participants with haemophilia or other congenitally acquired clotting factor deficiencies, participants with cirrhosis with coagulopathy, participants known to have thrombocytopenia (\<80,000 platelet/ul) and individuals with Von Willebrand's disease or other known platelet malfunction disorders) * Participant is enrolled in another research study with an investigational medicinal product (IMP) or non-IMP that pre-disposes them to bleeding
Contact & Investigator
Manish Chand, MBBS FRCS PhD
PRINCIPAL INVESTIGATOR
UCL
Frequently Asked Questions
Who can join the NCT05064124 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Polyps. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05064124 currently recruiting?
Yes, NCT05064124 is actively recruiting participants. Contact the research team at sharon.cheung@ucl.ac.uk for enrollment information.
Where is the NCT05064124 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05064124 clinical trial?
NCT05064124 is sponsored by University College, London. The principal investigator is Manish Chand, MBBS FRCS PhD at UCL. The trial plans to enroll 420 participants.