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Vitamin-D Receptor in Laryngeal Squamous Cell Carcinoma

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05568641
Collaborator
(none)
50
Enrollment
1.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Laryngeal squamous cell carcinoma (LSCC) is the second most common primary malignant tumor of the respiratory tract after lung cancer and the second most common primary epithelial malignant tumor of the head and neck. The age of onset of LSCC is mostly between 50 and 70 years, with a male to female ratio of approximately 4:1 .According to estimates by the American Cancer Society, in the United States, approximately 12,470 new cases of laryngeal cancer will be diagnosed and 3,820 people will die from laryngeal cancer in 2022.

The nuclear vitamin D receptor (VDR) is involved in multiple pathways that have many points of convergence. Some of these pathways are implicated in carcinogenesis thus the suggestion that VDR has a role to play in the biology of cancer [3]. Recent evidence indicates that the active form of vitamin D (1alpha, 25-dihydroxycholecalciferol) (VD) exhibits several different effects on normal and cancerous cells, including up-regulation of anti- proliferation and pro-apoptotic factors, as well as inhibition of cell-cycle promoters and growth factor signaling pathways. Thus it is useful as an anti-neoplastic agent in several human malignancies.

Studies in cell and animal model systems, as well as clinical trials have recognized the potential usefulness of VD and VD analogues as agents that enhance the anti-proliferative/cytotoxic effects of chemotherapy and ionizing radiation. Thus, at concentrations that produce limited hypercalcemia, these agents may be used as adjuncts to conventional chemotherapy and radiotherapy. We aim to analyze the expression of VDR in LSCC to determine potential for active VD therapy in such patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Immunohistochemical Expression of Vitamin-D Receptor in Laryngeal Squamous Cell Carcinoma
    Anticipated Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Diagnosis and prognosis of laryngeal squamous cell carcinoma [Two or three days after staining tissue sections with Vit D receptor antibody]

      Immunohistochemical Expression of Vitamin-D Receptor in Laryngeal Squamous Cell 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:
    NCT05568641
    Other Study ID Numbers:
    • Soh-Med-22-09-12
    First Posted:
    Oct 5, 2022
    Last Update Posted:
    Jan 18, 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
    Carcinoma, Squamous Cell
    Squamous Cell Carcinoma of Head and Neck

    Study Results

    No Results Posted as of Jan 18, 2023