Prospective Assessment of CONECCT's Classification for Colorectal Lesions.

Colorectal Cancer Clinical Trial

— pro-CONECCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05983315
• Other study ID #: 69HCL21_0780
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: August 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: November 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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