Analysis of Histopathological Factors Predictive of Lymph Node Involvement and Management Practices in pT1 Colorectal Cancers Treated by Primary Endoscopic Resection: a Retrospective Population-based Study (PROMOT1)

Colorectal Cancer Clinical Trial

— PROMOT1  

Official title:

Analysis of Histopathological Factors Predictive of Lymph Node Involvement and Management Practices in pT1 Colorectal Cancers Treated by Primary Endoscopic Resection: a Retrospective Population-based Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06339346
• Other study ID #: 29BRC24.0028 - PROMOT1
• Status: Active, not recruiting
• Start date: December 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Adenocarcinoma
• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
France	Chu Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of lymph node invasion rates as a function of tumor characteristics		10 years
Secondary	Population demographics		10 years
Secondary	lesion characteristics		10 years
Secondary	management		10 years
Secondary	recurrence		10 years
Secondary	survival		10 years