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SOX2 & PDL1 Expression on Urinary Bladder Carcinoma

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05429710
Collaborator
(none)
60
Enrollment
14
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Bladder carcinoma (BC) is the 13th leading cause of cancer mortality worldwide . In Egypt, BC is the third common malignant tumor. Its incidence is 8.7% of all malignant tumors in both sexes with more predominance in males as reported by National Cancer Registry with more expected cases in the future.

There are different histological variants of BC which show different phenotypic, biological and prognostic impacts. The most common histological type of BC is urothelial carcinoma which constitutes about 90% of all bladder cancers. Squamous cell carcinoma, adenocarcinoma and other rare types represent the remaining 10%.

Carcinoma of the bladder is considered a heterogeneous stem cell tumor with increasing morbidity and death rates if it is not treated properly. The presence of cancer stem cells (CSCs) is associated with tumor progression, recurrence, metastasis, and resistance to conventional chemotherapy and makes complete elimination of the tumor difficult. Successes in treatment plans need more understanding of the CSCs population and their molecular biology.

The most important items of CSCs regulatory core are transcription factors such as OCT4, SOX-2, and Nanog. They play an important role in the regulatory network for maintaining the 'stemness' state of stem cells.

SOX2 (short for Sex determing Region Y - box 2), a High Mobility Group (HMG) domain transcription factor is member of the SRY-related HMG-box (SOX) family of transcription factors involved in the pluripotency, self-reappearance and differentiation of embryonic stem cell.

Cancer immunotherapy starts with a proper understanding of tumor immuno-biology. Study of the tumor microenvironment revealed the importance of immune checkpoints in facilitating tumor immunological escape, leading to the development of multiple novel therapeutics targeting the PD-1/PD-L1 (programmed cell death protein 1, "CD279" programmed death ligand 1, "CD274") immune checkpoints. And recently the expression levels of PD-L1 are closely associated with CSCs immune escape.

PD-1 is a T-cell immune inhibitory checkpoint that inhibit T-cell activation and contributes to the immunosuppressive tumor microenvironment. PD-1 is also expressed on activated B cells and natural killer cells. PD-1 is activated by binding to its ligand; PD-L1, which is a type I trans-membrane glycoprotein. Many cell types express PD-L1, including placenta, vascular endothelium, hepatocytes and mesenchymal stem cells, also B cells, T cells, dendritic cells, macrophages, and mast cells.

PD-L1 is considered to be a co-inhibitory factor of the immune response, it can combine with PD-1 to reduce the proliferation of PD-1 positive cells, inhibit their cytokine secretion and induce apoptosis. PD-L1 also plays an important prognostic and predictive value in various malignancies where it can attenuate the host immune response to tumor cells.

However, little is known about the role of PD-L1 and its relation to SOX2 in urinary bladder carcinoma including its different histopathological variants. In this study, the main objective is to evaluate the immunohistochemical expression of PD-L1 to CSCs marker (SOX2) in urinary bladder carcinoma as a prognostic factor and search for new prospective targeted cancer therapy.

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 SOX2 and PD-L1 as Valuable Prognostic Markers in Urinary Bladder Carcinoma
    Anticipated Study Start Date :
    Oct 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Immunohistochemical Expression of SOX2 and PD-L1 as valuable prognostic markers in Urinary Bladder Carcinoma [one or two days after staining sections with the markers]

      To evaluate the expression of SOX2 and PD-L1 in urinary bladder carcinomas

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient with urinary bladder carcinoma.

    • Specimen with submitted muscle layer

    Exclusion Criteria:

    • Patients with insufficient clinical data.

    • Patients with recurrence of the primary tumor.

    • Specimens with extensive necrosis

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sohag University

    Investigators

    • Principal Investigator: alaa MS elmaghraby, Sohag University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alaa Mohamed Salah, assisstant lecturer, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05429710
    Other Study ID Numbers:
    • Soh-med-22-06-13
    First Posted:
    Jun 23, 2022
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    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
    Keywords provided by Alaa Mohamed Salah, assisstant lecturer, Sohag University
    SOX2, PDL1, prgnosis, urinary bladder carcinoma
    Additional relevant MeSH terms:
    Carcinoma
    Urinary Bladder Neoplasms

    Study Results

    No Results Posted as of Jun 23, 2022