Analysis of Histopathological Factors Predictive of Lymph Node Involvement and Management Practices in pT1 Colorectal Cancers Treated by Primary Endoscopic Resection

Active, not recruiting

• Conditions: Colorectal Cancer; Colorectal Adenocarcinoma

• Registration Number: NCT06339346
• Lead Sponsor: University Hospital, Brest

Brief Summary

Colorectal cancers (CRC) extending beyond the muscularis mucosae and invading the submucosa without extending beyond it are classified as pT1.

Among these, a number of lesions presenting pejorative criteria, notably histopathological, have a significant risk of lymph node invasion, and are therefore candidates for partial colectomy with lymph node dissection. Tumors deemed to be at low risk of lymph node involvement can be treated by endoscopy alone.

It should be noted that further surgical intervention is not without comorbid consequences, and that a significant proportion of post-surgical surgical specimens are free of cancerous lesions.

The aim of this study is therefore to analyze the current histopathological criteria predictive of lymph node invasion, in order to more accurately select candidates for surgical management.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-04-01
• Primary Completion: 2024-04-30
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Consecutive patients with pT1 colorectal cancer (of adenocarcinoma subtype only) diagnosed from January the 1st, 2009 to December the 31st, 2020, with first endoscopic resection, in the area of Finistère (France)

Exclusion Criteria

• other than adenocarcinoma
• other than T1
• primary surgical management
• neoadjuvant treatment
• refusal to data collection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of lymph node invasion rates as a function of tumor characteristics	10 years

Secondary Outcome Measures

Name	Time	Method
survival	10 years
Population demographics	10 years
lesion characteristics	10 years
management	10 years
recurrence	10 years

Trial Locations

Locations (1)

Chu Brest; 🇫🇷 Brest, France