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Trial Title:
Vitamin-D Receptor in Laryngeal Squamous Cell Carcinoma
NCT ID:
NCT05568641
Condition:
Laryngeal Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
90 Years
Healthy volunteers:
No
Start date:
January 2023
Completion date:
March 2023
Lead sponsor:
Agency:
Sohag University
Agency class:
Other
Source:
Sohag University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05568641
