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NCT07474025Recruiting

Biopsy-Resection Agreement of Peritoneal Histopathological Growth Patterns in Colorectal Peritoneal Metastases: A Prospective Observational Pilot Study

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

his prospective, single-center observational pilot study evaluates whether peritoneal histopathological growth patterns can be assessed on limited excisional biopsies obtained during staging laparoscopy in adults with suspected or confirmed colorectal peritoneal metastases. The study primarily evaluates agreement between the dominant histopathological growth pattern identified on laparoscopic biopsy and that identified on subsequent operative specimens. One to three peritoneal deposits will be sampled during staging laparoscopy. When surgery proceeds, up to three peritoneal deposits will be collected from the operative specimen, preferably from corresponding Peritoneal Cancer Index regions. Two pathologists, blinded to clinical information, specimen timing, and each other's assessments, will independently estimate the proportions of pushing and infiltrating growth patterns. Histopathological growth pattern findings will not be used to guide clinical management. Biopsy evaluability, interobserver reproducibility, interlesional heterogeneity, and exploratory associations with clinical and surgical characteristics will also be assessed.

Status (registry)
Recruiting
Study type
Observational
Enrollment
30 (estimated)
First submitted
11 Mar 2026
Start date
1 Mar 2026
Primary completion date
Dec 2028
Lead sponsor
Jules Bordet Institute
NCT number
NCT07474025

What you commit to

  • Study type: Observational
  • Planned participants: 30
  • From 1 Mar 2026 to the primary completion date, Dec 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Age \< 18 years

Other

  • Peritoneal metastases originating from non-colorectal primary tumors
  • Absence of available or adequate peritoneal metastasis tissue samples for histological growth pattern analysis
  • Patients who decline or withdraw informed consent
  • Patients unable to provide informed consent

Who the study is looking for

  • Age ≥ 18 years
  • Histologically confirmed colorectal adenocarcinoma
  • Suspected or confirmed peritoneal metastases from colorectal cancer based on imaging or prior clinical evaluation
  • Patients undergoing staging laparoscopy and/or cytoreductive surgery (CRS) ± hyperthermic intraperitoneal chemotherapy (HIPEC) as part of standard clinical care
  • Availability of peritoneal metastasis tissue samples suitable for histopathological analysis
  • Written informed consent provided for participation in the study

Age in the registry: - to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut Jules Bordet
Coordinator of this site? Confirm its status
BrusselsBelgiumRecruiting
Hub Bordet
Coordinator of this site? Confirm its status
BrusselsBelgiumNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.