Clinical trial NCT05568641: Vitamin-D Receptor in Laryngeal Squamous Cell Carcinoma
Official title: Immunohistochemical Expression of Vitamin-D Receptor in Laryngeal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laryngeal Carcinoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Diagnosis and prognosis of laryngeal squamous cell carcinoma
timeFrame: Two or three days after staining tissue sections with Vit D receptor antibody
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of medicine ,Sohag university
name: Amira A Abdelnaby, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: