Assessment of Intratumoral Budding (ITB) in Preoperative Biopsies of Colon and Rectal Cancer Patients: a Prospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- correlation of ITB based calculated N stage with real N stage in CRC - patients
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
correlation of ITB based calculated N stage with real N stage in CRC - patients
Time Frame: 24 months
Secondary Outcomes
- correlation of ITB based calculated DFS with real DFS in CRC - patients(24 months)