Status:
RECRUITING
Lumeneye Rectoscope for Assessment on Tumor Response After Total Neoadjuvant Treatment in Rectal Cancer
Lead Sponsor:
Bordeaux Colorectal Institute Academy
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
The recent validation of the Total Neoadjuvant Treatment (TNT) protocol and the improvement of techniques for evaluating tumor response are two major factors in the development of organ preservation i...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 4 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06189846
Start Date
January 4 2024
End Date
September 1 2025
Last Update
September 12 2025
Active Locations (8)
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1
Clinique Tivoli-Ducos - Bordeaux Colorectal Institute
Bordeaux, France
2
Hôpital Européen de Marseille
Marseille, France
3
Hôpital Saint-Antoine - APHP
Paris, France
4
CHU de ROUEN
Rouen, France