Web-based learning module for diagnosing early colorectal cancer
Web-based Learning Module to Increase the Accuracy of Optical Diagnosis for Detecting the Invasive Pattern of Colorectal Polyps (LODIP Study). Randomised Controlled Trial
NA · Althaia Xarxa Assistencial Universitària de Manresa · NCT05663788
This study tests if an online training program can help gastroenterologists better spot early signs of colorectal cancer during colonoscopies.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 28 Years and up |
| Sex | All |
| Sponsor | Althaia Xarxa Assistencial Universitària de Manresa (other) |
| Locations | 12 sites (Chapel Hill, North Carolina and 11 other locations) |
| Trial ID | NCT05663788 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of an e-learning module designed for gastroenterologists to improve their skills in optical diagnosis of colorectal lesions. The study will compare the sensitivity and diagnostic accuracy of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps during routine colonoscopies between gastroenterologists who participate in the learning module and those who do not. Participants will document their findings on endoscopic lesions and clinical outcomes over a year, with assessments made before and after the training. The goal is to enhance the ability of gastroenterologists to accurately diagnose early colorectal cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are gastroenterologists who have performed over 300 colonoscopies and are in their final year of training or have completed their residency since 2014.
Not a fit: Patients who have undergone training in centers with a high diagnostic accuracy for predicting deep submucosal invasion may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the accuracy of colorectal cancer diagnoses, leading to better patient outcomes.
How similar studies have performed: Other studies have shown success in improving diagnostic accuracy through educational interventions, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gastroenterologists who have performed \> 300 colonoscopies without supervision and are in the last training year or had finished the Gastroenterology residency after 2014. Exclusion Criteria: * Endoscopists who have learned the invasive pattern in a centre where endoscopists have published a high diagnostic accuracy for predicting deep submucosal invasion (Japanese centres).
Where this trial is running
Chapel Hill, North Carolina and 11 other locations
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (ACTIVE_NOT_RECRUITING)
- National Cancer Center — Chuo, Tokyo, Japan (ACTIVE_NOT_RECRUITING)
- Hospital Germans Trias i Pujol — Badalona, Barcelona, Spain (ACTIVE_NOT_RECRUITING)
- Althaia Xarxa Assistencial Universitària de Manresa — Manresa, Barcelona, Spain (RECRUITING)
- Consorci Sanitari de Terrassa — Terrassa, Barcelona, Spain (ACTIVE_NOT_RECRUITING)
- Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar, Murcia, Spain (ACTIVE_NOT_RECRUITING)
- Hospital Comarcal de Alcañiz — Alcañiz, Teruel, Spain (ACTIVE_NOT_RECRUITING)
- Hospital Clínic i Provincial de Barcelona — Barcelona, Spain (ACTIVE_NOT_RECRUITING)
- Hospital Universitario Ramón y Cajal — Madrid, Spain (ACTIVE_NOT_RECRUITING)
- Hospital Universitario 12 de Octubre — Madrid, Spain (ACTIVE_NOT_RECRUITING)
- Hospital Universitari i Politècnic La Fe — Valencia, Spain (ACTIVE_NOT_RECRUITING)
- Nottingham University Hospitals NHS Trust — Nottingham, Nottinghamshire, United Kingdom (ACTIVE_NOT_RECRUITING)
Study contacts
- Principal investigator: Ignasi Puig, PhD — Althaia Xarxa Assistencial Universitària de Manresa
- Study coordinator: Anna Arnau, PhD
- Email: aarnau@althaia.cat
- Phone: +34938759300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Cancer, Colorectal Cancer Stage I, advance endoscopy, collaborative research, colonoscopy, early colorectal cancer, colorectal polyps, optical diagnosis