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Clinical Trials/NCT06339346
NCT06339346Active, not recruitingNot Applicable

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

University Hospital, Brest1 site in 1 country400 target enrollmentStarted: December 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
400
Locations
1
Primary Endpoint
Analysis of lymph node invasion rates as a function of tumor characteristics

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Analysis of lymph node invasion rates as a function of tumor characteristics

Time Frame: 10 years

Secondary Outcomes

  • survival(10 years)
  • lesion characteristics(10 years)
  • Population demographics(10 years)
  • management(10 years)
  • recurrence(10 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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