Rectal CancerLUMEVALNCT06189846
Lumeneye Rectoscope for Assessment on Tumor Response After Total Neoadjuvant Treatment in Rectal Cancer
An observational study of Rectal Cancer, run by Bordeaux Colorectal Institute Academy at 8 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- International Cohort
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 4 Jan 2024to 5 Mar 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 10Show fewer
- Baseline Tumour size ≤ 5 cm (MRI)
- Baseline Tumour ≤ 8 from anal verge
- Ability to consent.
- Oral agreement after reading information letter
Who cannot join
- 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
Show all 9Show fewer
- Patient with a history of pelvic radiotherapy or chemotherapy
- Pregnant patients
- Protected adults (individuals under guardianship by court order).
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
France4 sites
Clinique Tivoli-Ducos - Bordeaux Colorectal Institute
Bordeaux
Hôpital Européen de Marseille
Marseille
Hôpital Saint-Antoine - APHP
Paris
CHU de ROUEN
Rouen
About this study
Official title: 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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- International Cohort
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
International CohortDevice
Assessing tumour response following neoadjuvant treatment in rectal cancer include :
- Digital rectal examination
- Rectal MRI
- Rectoscopy ( Lumeneye device)
The monitoring of tumour response intervals up to 6 months following completion of the neoadjuvant treatment at 8 weeks, at 16 weeks, at 24 weeks after the end of neoadjuvant treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of complete and/or nearly complete response
To evaluate the complete and/or nearly complete response with LumenEye digital endoscopescope
Measured: From 8 weeks to 24 weeks after the end of radiotherapy
Secondary outcomes (5)
Agreement for grading rectal tumour response between the endoscopic and MRI assessment of tumour response
To evaluate the concordance between the endoscopic and MRI assessment of tumor response
Measured: 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
- To evaluate the concordance between the clinical and endoscopic assessment of tumor response.
Measured: 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.
To evaluate the concordance between the clinical and MRI assessment of tumor response.
Measured: From 8 weeks to 24 weeks after the end of radiotherapy
Interobserver agreement for grading rectal tumour response using a digital rectoscope platform
To assess the interobserver reproducibility of endoscopic response with LumenEye digital endoscope within 6 months after the end of neoadjuvant treatment.
Measured: 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).
To evaluate the contribution of the digital ectoscope platform in the surgeon's decision-making
Measured: From 8 weeks to 24 weeks after the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start4 Jan 2024
- Primary completion17 Oct 2025
- Study completion5 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Bordeaux Colorectal Institute Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Quentin DENOST, Study director, Bordeaux Colorectal Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189846
- Sponsor's protocol ID
- BCIA 2023/02
- Acronym
- LUMEVAL
- Status last verified
- May 2026
- First submitted
- 19 Dec 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Incorporating LUMENEYE Rectoscope for Assessment on Tumor Response After Total Neoadjuvant Treatment in Rectal Cancer
- ClinicalTrials.gov ID
- NCT06189846
- Acronym / sponsor ID
- LUMEVAL / BCIA 2023/02
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Bordeaux Colorectal Institute AcademyUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (9 listed)
- Tumour cT1 or cT4
- Baseline Tumour size > 5cm
- Invaded external sphincter or levator muscle
- Tumour cN2 (> 3 positive LN or size > 8 mm)
- Metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| International CohortAssessing tumour response following neoadjuvant treatment in rectal cancer include : * Digital rectal examination * Rectal MRI * Rectoscopy ( Lumeneye device) The monitoring of tumour response intervals up to 6 months following completion of the neoadjuvant treatment at 8 weeks, at 16 weeks, at 24 weeks after the end of neoadjuvant treatment. | Device | – |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quentin DENOST study director
Bordeaux Colorectal Institute
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Bordeaux Colorectal Institute Academy at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Italy, Netherlands, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of complete and/or nearly complete response (time frame: From 8 weeks to 24 weeks after the end of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.