pro-CONECCT: Prospective Assessment of CONECCT's Classification for Colorectal Lesions.

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT05983315
Collaborator
(none)
750
1
16
46.8

Study Details

Study Description

Brief Summary

Colorectal neoplastic lesion endoscopic characterization is a key element for histological predictive diagnostic value in conducting best appropriate resection choice. Six classifications are necessary for fully correct characterization of different colorectal lesions. Nonetheless, it can be tricky to use so many diagnostic tools with so many subcategories in the 6 existing classifications. That's why we decided to integrate all 6 existing classification validated factors in one single chart (CONECCT chart) allowing to both predict histological diagnostic value and to propose the best appropriate resection strategy. A previous prospective and multicentre study with all French medical residents in gastroenterology was conducted in order to prove pedagogic interest of this diagnostic tool. Each student was asked to review 20 files with lesion pictures before and after lecture about CONECCT chart. This allowed us to prove that this diagnostic tool could significantly improve both histological predictive diagnostic value and therapeutic choice by French medical residents and gastroenterologists. Our hypothesis is that CONECCT's classification can improve predictive diagnostic value of colorectal lesions in over 80% of cases. Now that pedagogic interest of this diagnostic tool has been proven, we would like to carry out a larger prospective assessment in term of performance (value) of this instrument in order to both facilitate endoscopic characterization and allow a most appropriate diagnostic and therapeutic management of each colorectal lesion category.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    750 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Assessment of CONECCT's Classification for Histological Predictive Diagnostic Value in Conducting Therapeutic Choice for Colorectal Lesions. Pro-CONECCT
    Actual Study Start Date :
    Jul 1, 2021
    Actual Primary Completion Date :
    Jul 1, 2022
    Actual Study Completion Date :
    Nov 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    CONECCT's classification assessment

    Every patient who needs diagnostic colonoscopy because of digestive symptoms, medical or family history of colorectal cancer/polyps, positive colorectal screening test, acromegaly or referred by another gastroenterologist upon discovery of colorectal polyp after colonoscopy can join the cohort of this study and can get CONECCT's classification histological assessment of their neoplastic lesion by experienced endoscopist.

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between endoscopic CONECCT's classification [Time point can be reached either 2 weeks after endoscopic resection at V1 or between 2-4 months later in case of surgery at V3]

      assessed by one of research site operators and final histology reading of neoplastic lesion by anatomopathologist: CONECCT 0E : neuroendocrine tumor CONECCT IH : hyperplastic polyp CONECCT IS : sessile serrated lesion with or without dysplasia CONECCT IIA : low or high grade adenoma CONECCT IIC : low or high grade adenoma or intramucosal or submucosal <1000 micron adenocarcinoma CONECCT III : deep invasive submucosal > 1000 microns adenocarcinoma

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • Inclusion Criteria :

    • both gender patients even or older than 18 years old

    • patient in need of proven diagnostic or therapeutic colonoscopy for colorectal lesion resection

    • patient with French Health Insurance coverage

    • obtaining of oral non opposition to research after loyal, clear and complete delivery of information

    • Exclusion Criteria :

    • previous attempt of lesion resection by mucosectomy

    • patient with a metastatic lesion diagnosed prior to colonoscopy

    • patient with no colorectal lesion

    • adenomatous or sessile serrated polyposis syndrome

    • patient with bowel chronic inflammatory disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Edouard Herriot Lyon France 69437

    Sponsors and Collaborators

    • Hospices Civils de Lyon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospices Civils de Lyon
    ClinicalTrials.gov Identifier:
    NCT05983315
    Other Study ID Numbers:
    • 69HCL21_0780
    First Posted:
    Aug 9, 2023
    Last Update Posted:
    Aug 9, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hospices Civils de Lyon
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2023