Clincosm LogoSign in Get a demo

PDL1 In Primary Colorectal Carcinoma and Its Prognostic Impact

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05692895
Collaborator
(none)
60
Enrollment
4.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Colorectal cancer (CRC) is a highly heterogenous disease. It the third most commonly diagnosed cancer in the world and the second cause of death among cancer cases mortality. Its incidence is rising all over the world, especially in developing countries . In Egypt it is coming the seventh cancer in incidence according to World Health Organization (WHO, 2020). Although there is much improvement in the diagnosis and treatment, but CRC is still constituting a big impact on human life and health, so researchers are trying to find out new therapeutic targets .

Programmed cell death protein 1 (PD-1) is an inhibitory receptor which is expressed on the surface of T lymphocytes during activation. Its role is to control T cell effector activity for various cellular responses as infections, autoimmune reactions, and cancer .

Cancer cells develop PD-ligand1 (PD-L1) expression which is a transmembrane molecule belonging to B7 family. Its action is through PD-1/PD-L1 reaction, and causing invasion and metastasis of cancer cells by protecting it from immunosurveillance by inhibiting T cell effector function, leading to carcinogenesis and development of many cancers including colorectal cancer.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Immunohistochemical Expression of PDL1 In Primary Colorectal Carcinoma and Its Prognostic Impact
    Anticipated Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    Jul 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Diagnosis and prognosis of colorectal carcinoma [Two or three days after staining tissue sections with PDL1 antibody]

      Immunohistochemical expression of PDL1 in primary colorectal carcinoma

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Both endoscopic and excisional biopsy specimens.

    2. All the studied cases include sufficient materials for the immunohistochemical study.

    3. Complete clinical data

    Exclusion Criteria:

    1. Patients with recurrence of the primary tumor.

    2. Patients with a history of preoperative chemotherapy and/or radiotherapy.

    3. Insufficient or tiny tissue biopsies

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sohag University

    Investigators

    • Principal Investigator: Amira A Abdelnaby, Lecturer, Faculty of medicine ,Sohag university

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amira Ahmed Abdelnaby, Lecturer of pathology, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05692895
    Other Study ID Numbers:
    • Soh-Med-22-12-36
    First Posted:
    Jan 20, 2023
    Last Update Posted:
    Jan 20, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Jan 20, 2023