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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer

• Study Type: Observational
• Enrollment (Actual): 750

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69437
    • Hôpital Edouard Herriot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between endoscopic CONECCT's classification	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	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: colorectal cancer; diagnostic tool; therapeutic choice guidance; CONECCT
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 69HCL21_0780

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No