NCT05568641

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

Same day

First QC Date

October 2, 2022

Last Update Submit

January 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Both endoscopic and excisional biopsy specimens.
  • All the studied cases include sufficient materials for the immunohistochemical study.
  • Complete clinical data

You may not qualify if:

  • Patients with recurrence of the primary tumor.
  • Patients with a history of preoperative chemotherapy and/or radiotherapy.
  • Insufficient or tiny tissue biopsies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic Diseases

Study Officials

  • Amira A Abdelnaby, Lecturer

    Faculty of medicine ,Sohag university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira A Abdelnaby, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of pathology

Study Record Dates

First Submitted

October 2, 2022

First Posted

October 5, 2022

Study Start

January 1, 2023

Primary Completion

January 1, 2023

Study Completion

March 1, 2023

Last Updated

January 18, 2023

Record last verified: 2023-01