Trials Sponsors Conditions Drugs Pricing

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

The rate of complete and/or nearly complete response
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 Outcomes (5)

Agreement for grading rectal tumour response between the endoscopic and MRI assessment of tumour 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
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.
From 8 weeks to 24 weeks after the end of radiotherapy
Interobserver agreement for grading rectal tumour response using a digital rectoscope platform
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).
From 8 weeks to 24 weeks after the end of radiotherapy

Interventions

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.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

You may qualify if:

Patient ≥ 18 years

Sponsors & Collaborators

Bordeaux Colorectal Institute Academy
Otherlead

Study Sites (8)

Clinique Tivoli-Ducos - Bordeaux Colorectal Institute

Bordeaux, France

Hôpital Européen de Marseille

Marseille, France

Hôpital Saint-Antoine - APHP

Paris, France

CHU de ROUEN

Rouen, France

Humanitas Research Hospital

Milan, Italy

Amsterdam UMC

Amsterdam, Netherlands

University Hospital Vall D'Hebron

Barcelona, Spain

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

Quentin DENOST
Bordeaux Colorectal Institute
STUDY DIRECTOR

Enrollment

82 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 6 Months
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 5, 2024

Study Start

January 4, 2024

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations