Vitamin-D Receptor in Laryngeal Squamous Cell Carcinoma

January 16, 2023 updated by: Amira Ahmed Abdelnaby, Sohag University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two or three days after staining tissue sections with Vit D receptor antibody

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Amira A Abdelnaby, Lecturer, Faculty of medicine ,Sohag university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

October 2, 2022

First Submitted That Met QC Criteria

October 2, 2022

First Posted (Actual)

October 5, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-09-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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