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

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03336658
Collaborator
(none)
150
Enrollment
1
Location
75
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Intratumoral Budding (ITB) in Preoperative Biopsies of Colon and Rectal Cancer Patients: a Prospective Observational Study
    Actual Study Start Date :
    Oct 1, 2015
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. correlation of ITB based calculated N stage with real N stage in CRC - patients [24 months]

    Secondary Outcome Measures

    1. correlation of ITB based calculated DFS with real DFS in CRC - patients [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of visceral surgery and transplant surgery, Berne University Hospital Berne Switzerland 3010

    Sponsors and Collaborators

    • University Hospital Inselspital, Berne

    Investigators

    • Principal Investigator: Beat Schnüriger, PD, University Hospital Inselspital, Berne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Inselspital, Berne
    ClinicalTrials.gov Identifier:
    NCT03336658
    Other Study ID Numbers:
    • 393/14
    First Posted:
    Nov 8, 2017
    Last Update Posted:
    Sep 30, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rectal Neoplasms

    Study Results

    No Results Posted as of Sep 30, 2020