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Active Not RecruitingNCT03336658

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

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
Insel Gruppe AG, University Hospital Bern · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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.

Conditions

Timeline

Start date
2015-10-01
Primary completion
2024-12-31
Completion
2024-12-31
First posted
2017-11-08
Last updated
2024-11-13

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03336658. Inclusion in this directory is not an endorsement.

Intratumoral Budding (ITB) in Preoperative Biopsies of Colon and Rectal Cancer (NCT03336658) · Clinical Trials Directory