Vitamin-D Receptor in Laryngeal Squamous Cell Carcinoma

Laryngeal Carcinoma Clinical Trial

Official title:

Immunohistochemical Expression of Vitamin-D Receptor in Laryngeal Squamous Cell Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05568641
• Other study ID #: Soh-Med-22-09-12
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: March 2023

Study information

• Verified date: January 2023
• Source: Sohag University
• Contact: Amira A Abdelnaby, Lecturer
• Phone: 01002097612
• Email: ameraabdelnaby55[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Laryngeal Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis and prognosis of laryngeal squamous cell carcinoma	Immunohistochemical Expression of Vitamin-D Receptor in Laryngeal Squamous Cell Carcinoma	Two or three days after staining tissue sections with Vit D receptor antibody