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OpenTrials
Completed

NCT Number: NCT05983315

Prospective Assessment of CONECCT's Classification for Colorectal Lesions.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Edouard Herriot

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. Correlation between endoscopic CONECCT's classification

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Prospective Assessment of CONECCT's Classification for Histological Predictive Diagnostic Value in Conducting Therapeutic Choice for Colorectal Lesions. Pro-CONECCT

Acronym: pro-CONECCT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2023
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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