Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| International Cohort | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The rate of complete and/or nearly complete response
- timeFrame
- From 8 weeks to 24 weeks after the end of radiotherapy
- description
- To evaluate the complete and/or nearly complete response with LumenEye digital endoscopescope
Secondary outcomes (5)
- measure
- Agreement for grading rectal tumour response between the endoscopic and MRI assessment of tumour response
- timeFrame
- From 8 weeks to 24 weeks after the end of radiotherapy
- description
- To evaluate the concordance between the endoscopic and MRI assessment of tumor response
- measure
- Agreement for grading rectal tumour response between the clinical and endoscopic assessment of tumour response
- timeFrame
- From 8 weeks to 24 weeks after the end of radiotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available