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Completed

NCT Number: NCT03336658

Intratumoral Budding (ITB) in Preoperative Biopsies of Colon and Rectal Cancer

All the preoperative biopsies of patients suffering colorectal cancer (CRC) will be immunohistochemically stained with a pancytokeratin marker to detect Tumor buds. then, the intratumoral buds (ITB) in the densest Region of Tumor buds, namely the "hot spot" will be counted. Subsequently, the probability of N stage (lymphnodes), M stage (metastases) and disease free survival (DFS) will be calculated based on an existing logistic Regression model already developed by our previous retrospective work. Additionally, a Standardisation of ITB using a well- established Software will develop an algorithm which will help to eliminate inter- observer variability of Tumor budding Counts.

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Key information

Conditions

CRC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of visceral surgery and transplant surgery, Berne University Hospital

Bern, 3010, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with newly diagnosed stages I and IV colorectal cancer (CRC)
  • Age ≥ 18 years
  • Written Informed Consent

Exclusion criteria

  • No consent
  • < 18 years

Treatment and study plan

Primary outcomes

  1. correlation of ITB based calculated N stage with real N stage in CRC - patients

    Time frame: 24 months

Secondary outcomes

  1. correlation of ITB based calculated DFS with real DFS in CRC - patients

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Assessment of Intratumoral Budding (ITB) in Preoperative Biopsies of Colon and Rectal Cancer Patients: a Prospective Observational Study

Acronym: ITB

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2017
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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