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

Active, not recruiting

• Conditions: CRC

• Registration Number: NCT03336658
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
correlation of ITB based calculated N stage with real N stage in CRC - patients	24 months

Secondary Outcome Measures

Name	Time	Method
correlation of ITB based calculated DFS with real DFS in CRC - patients	24 months

Trial Locations

Locations (1)

Department of visceral surgery and transplant surgery, Berne University Hospital; 🇨🇭 Berne, Switzerland