NCT06189846Completed
Lumeneye Rectoscope for Assessment on Tumor Response After Total Neoadjuvant Treatment in Rectal Cancer
Prospective Study Incorporating LUMENEYE Rectoscope for Assessment on Tumor Response After Total Neoadjuvant Treatment in Rectal Cancer
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
The objective of this prospective international cohort is to evaluate the LUMENEYE rectoscope for assessment on tumor response after total neoadjuvant treatment in rectal cancer. Patients included in this study will be patients who initially will be good candidates for organ preservation. The participating centers are all expert centers in tumor assessment. All patient assessments after neoadjuvant treatment for rectal adenocarcinoma will be included in each centre.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 82 (actual)
- First submitted
- 19 Dec 2023
- Start date
- Jan 2024
- Primary completion date
- Oct 2025
- Lead sponsor
- Bordeaux Colorectal Institute Academy
- Diseases
- Colorectal cancer
- NCT number
- NCT06189846
What you commit to
- Study type: Observational
- Participants enrolled: 82
- From Jan 2024 to the primary completion date, Oct 2025
- 8 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of Inflammatory bowel disease
- Patient with a history of pelvic radiotherapy or chemotherapy
Other
- Tumour cT1 or cT4
- Baseline Tumour size \> 5cm
- Invaded external sphincter or levator muscle
- Tumour cN2 (\> 3 positive LN or size \> 8 mm)
- Metastasis
- Pregnant patients
- Protected adults (individuals under guardianship by court order).
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Clinique Tivoli-Ducos - Bordeaux Colorectal Institute Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Hôpital Européen de Marseille Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hôpital Saint Antoine APHP Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU de Rouen Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Imperial College London Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.