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Vitamin-D Receptor in Laryngeal Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT05568641
Recruitment Status : Not yet recruiting
First Posted : October 5, 2022
Last Update Posted : October 12, 2022
Information provided by (Responsible Party):
Amira Ahmed Abdelnaby, Sohag University

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
Laryngeal Carcinoma

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Immunohistochemical Expression of Vitamin-D Receptor in Laryngeal Squamous Cell Carcinoma
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Primary Outcome Measures :
  1. Diagnosis and prognosis of laryngeal squamous cell carcinoma [ Time Frame: Two or three days after staining tissue sections with Vit D receptor antibody ]
    Immunohistochemical Expression of Vitamin-D Receptor in Laryngeal Squamous Cell Carcinoma

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A retrospective study will be carried out on 50 LSCC specimens that were collected randomly from archives of Pathology Department, Faculty of Medicine, Sohag University

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05568641

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Contact: Amira A Abdelnaby, Lecturer 01002097612 ameraabdelnaby55@gmail.com

Sponsors and Collaborators
Sohag University
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Principal Investigator: Amira A Abdelnaby, Lecturer Faculty of medicine ,Sohag university
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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: October 5, 2022    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site