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CompletedNCT03336658ITBUpdated May 5, 2026

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

An observational study in CRC, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • CRC
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Stages I to IV colorectal cancer

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No consent
  • \< 18 years
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
05

What researchers measure

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

06

Study locations

1 site
  • Department of visceral surgery and transplant surgery, Berne University Hospital
    Bern, 3010, Switzerland
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03336658
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Responsible party
Sponsor
First posted
Nov 8, 2017
Start date
Oct 1, 2015
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
May 5, 2026

Study contacts

Beat Schnüriger, PD
principal investigator · Insel Gruppe AG, University Hospital Bern

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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