Using Lumeneye Rectoscope to Evaluate Tumor Response in Rectal Cancer After Treatment
Prospective Study Incorporating LUMENEYE Rectoscope for Assessment on Tumor Response After Total Neoadjuvant Treatment in Rectal Cancer
This study is testing if the LUMENEYE rectoscope can help doctors see how well treatment is working for patients with rectal cancer who are hoping to keep their organs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bordeaux Colorectal Institute Academy Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 8 sites (Bordeaux and 7 other locations) |
| Trial ID | NCT06189846 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of the LUMENEYE rectoscope in evaluating tumor response following total neoadjuvant treatment in patients with rectal cancer. It involves a prospective international cohort of patients who are candidates for organ preservation. The study will include clinical assessments and morphological examinations, such as rectal MRI, to monitor tumor response over a six-month period. The goal is to improve patient selection and evaluation methods for organ preservation strategies in rectal cancer treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed adenocarcinoma of the rectum who have undergone total neoadjuvant treatment.
Not a fit: Patients with advanced tumors (cT1 or cT4), those with metastasis, or individuals with a history of inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of tumor response assessments, leading to better organ preservation outcomes for rectal cancer patients.
How similar studies have performed: Other studies have shown promising results with organ preservation strategies in rectal cancer, indicating that this approach may build on existing knowledge.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient ≥ 18 years * Histologically confirmed diagnosis of adenocarcinoma of the rectum, * Patient who received radiotherapy and chemotherapy (TNT) or immunotherapy * Stage cT2T3 * cN0 or cN1 (≤ 3 positive LN or size ≤ 8 mm) * no metastases * Baseline Tumour size ≤ 5 cm (MRI) * Baseline Tumour ≤ 8 from anal verge * Ability to consent. * Oral agreement after reading information letter Exclusion Criteria: * Tumour cT1 or cT4 * Baseline Tumour size \> 5cm * Invaded external sphincter or levator muscle * Tumour cN2 (\> 3 positive LN or size \> 8 mm) * Metastasis * History of Inflammatory bowel disease * Patient with a history of pelvic radiotherapy or chemotherapy * Pregnant patients * Protected adults (individuals under guardianship by court order).
Where this trial is running
Bordeaux and 7 other locations
- Clinique Tivoli-Ducos - Bordeaux Colorectal Institute — Bordeaux, France (Recruiting)
- Hôpital Européen de Marseille — Marseille, France (Recruiting)
- Hôpital Saint-Antoine - APHP — Paris, France (Not_yet_recruiting)
- CHU de ROUEN — Rouen, France (Not_yet_recruiting)
- Humanitas Research Hospital — Milan, Italy (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Not_yet_recruiting)
- University Hospital Vall D'Hebron — Barcelona, Spain (Recruiting)
- Imperial College London — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Quentin DENOST, Prof
- Email: q.denost@bordeaux-colorectal-institute.fr
- Phone: +33 547501575
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.