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Analysis of Histopathological Factors Predictive of Lymph Node Involvement and Management Practices in pT1 Colorectal Cancers Treated by Primary Endoscopic Resection (PROMOT1)

R

Regional University Hospital Center (CHRU)

Status

Active, not recruiting

Conditions

Colorectal Adenocarcinoma
Colorectal Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT06339346
29BRC24.0028 - PROMOT1

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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