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NCT03336658 Clinical Trial

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

CRC Clinical Trial

— ITB  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03336658
Other study ID # 393/14
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2015
Est. completion date December 31, 2023

Study information
Verified date January 2023
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Department of visceral surgery and transplant surgery, Berne University Hospital Berne

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary correlation of ITB based calculated N stage with real N stage in CRC - patients 24 months
Secondary correlation of ITB based calculated DFS with real DFS in CRC - patients 24 months
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