Prospective Study Incorporating LUMENEYE Rectoscope for Assessment on Tumor Response After Total Neoadjuvant Treatment in Rectal Cancer

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Clinique Tivoli-Ducos - Bordeaux Colorectal Institute
RECRUITING
Bordeaux
Hôpital Européen de Marseille
RECRUITING
Marseille
Hôpital Saint-Antoine - APHP
RECRUITING
Paris
CHU de ROUEN
NOT_YET_RECRUITING
Rouen
Italy
Humanitas Research Hospital
RECRUITING
Milan
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Spain
University Hospital Vall D'Hebron
RECRUITING
Barcelona
United Kingdom
Imperial College London
NOT_YET_RECRUITING
London
Contact Information
Primary
Quentin DENOST, Prof
q.denost@bordeaux-colorectal-institute.fr
+33 547501575
Backup
Stéphanie GUILLON
s.guillon@bordeaux-colorectal-institute.fr
+33 668686805
Time Frame
Start Date: 2024-01-04
Estimated Completion Date: 2025-09
Participants
Target number of participants: 100
Related Therapeutic Areas
Sponsors
Leads: Bordeaux Colorectal Institute Academy

This content was sourced from clinicaltrials.gov