Lumeneye Rectoscope for Assessment on Tumor Response After Total Neoadjuvant Treatment in Rectal Cancer (LUMEVAL)

May 4, 2026 updated by: Bordeaux Colorectal Institute Academy

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 in rectal cancer.

Although recent publications have shown promising results of the two organ preservation strategies, Watch & Wait and Local excision, with a low oncological risk, some challenges remain to be addressed before the generalization of rectal preservation in clinical practice.

Among these challenges, the improvement of patient selection and methods for evaluating tumor response appear necessary. The monitoring scheme for the tumor response has not yet been clearly established, but a 6 months programme of tumor response assessment has been recently published (Boubaddi EJSO 2023). Monitoring must consist of a clinical assessment (rectal examination and/or rectoscopy) and additional morphological examinations (rectal MRI) every two months.

Tumor response after neoadjuvant treatment by MRI (TRG 1-5, Tumor Regression Grade) is established as a reliable method of tumor response assessment and accurate diagnosis of complete clinical response. However, discrepancies between clinical examination and radiological MRI may exist and patients undergoing watch-and-wait who develop local regrowth due to mistake in initial tumour response assessment are at higher risk for development of distant metastases (Sao Juliao DCR 2023) with a poor impact on long term oncological results.

The development of the LumenEye digital rectoscope by the SurgEase company enables a comfortable and efficient scoping for the user and the patient (Lewis J BJGP Open 2022). With high quality images of Full HD images and video associated with a secure and connected intuitive software platform, this endoscope can have its place in the monitoring of tumor response.

The contribution of this technology to the monitoring of the tumor response needs to be assessed. This medical device is CE marked and used in its intended purpose.

The objective of this study is to evaluate the complete and/or nearly complete response with LumenEye digital rectoscope.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Clinique Tivoli-Ducos - Bordeaux Colorectal Institute
      • Marseille, France
        • Hôpital Européen de Marseille
      • Paris, France
        • Hôpital Saint-Antoine - APHP
      • Rouen, France
        • CHU de Rouen
  • Italy
      • Milan, Italy
        • Humanitas Research Hospital
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam UMC
  • Spain
      • Barcelona, Spain
        • University Hospital Vall d'Hebron
  • United Kingdom
      • London, United Kingdom
        • Imperial College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

These are patients with small rectal cancer, initially good candidates for organ preservation and whose evaluation is done by clinical and radiological examination and with the Lumeneye rectoscope

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The rate of complete and/or nearly complete response
Time Frame: From 8 weeks to 24 weeks after the end of radiotherapy
To evaluate the complete and/or nearly complete response with LumenEye digital endoscopescope
From 8 weeks to 24 weeks after the end of radiotherapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Agreement for grading rectal tumour response between the endoscopic and MRI assessment of tumour response
Time Frame: From 8 weeks to 24 weeks after the end of radiotherapy
To evaluate the concordance between the endoscopic and MRI assessment of tumor response
From 8 weeks to 24 weeks after the end of radiotherapy
Agreement for grading rectal tumour response between the clinical and endoscopic assessment of tumour response
Time Frame: From 8 weeks to 24 weeks after the end of radiotherapy
- To evaluate the concordance between the clinical and endoscopic assessment of tumor response.
From 8 weeks to 24 weeks after the end of radiotherapy
Agreement for grading rectal tumour response between the clinical and MRI assessment of tumour response.
Time Frame: From 8 weeks to 24 weeks after the end of radiotherapy
To evaluate the concordance between the clinical and MRI assessment of tumor response.
From 8 weeks to 24 weeks after the end of radiotherapy
Interobserver agreement for grading rectal tumour response using a digital rectoscope platform
Time Frame: From 8 weeks to 24 weeks after the end of radiotherapy
To assess the interobserver reproducibility of endoscopic response with LumenEye digital endoscope within 6 months after the end of neoadjuvant treatment.
From 8 weeks to 24 weeks after the end of radiotherapy
Rate of changing attitude after using the digital rectoscope platform (intra-observer changing management).
Time Frame: From 8 weeks to 24 weeks after the end of radiotherapy
To evaluate the contribution of the digital ectoscope platform in the surgeon's decision-making
From 8 weeks to 24 weeks after the end of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bordeaux Colorectal Institute Academy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Quentin DENOST, Bordeaux Colorectal Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 17, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BCIA 2023/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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