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

January 24, 2023 updated by: University Hospital Inselspital, Berne

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Berne, Switzerland, 3010
        • Department of visceral surgery and transplant surgery, Berne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Stages I to IV colorectal cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
correlation of ITB based calculated N stage with real N stage in CRC - patients
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
correlation of ITB based calculated DFS with real DFS in CRC - patients
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Beat Schnüriger, PD, University Hospital Inselspital, Berne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

November 6, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (Actual)

November 8, 2017

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 393/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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