Expression of Programmed Death Ligand-1 (PD-L1) in Nasopharyngeal and Hyypopharyngeal Carcinoma

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05595265
Collaborator
(none)
50
1
12
4.2

Study Details

Study Description

Brief Summary

Head and neck tumors comprise heterogeneous neoplasms that arise from surface epithelium of different anatomic subsites in head and neck region such as oral cavity, oropharynx, larynx and hypopharynx. Nasopharyngeal and hypopharyngeal carcinomas represent 0.26 % of all cancers in Egypt. Tobacco exposure and alcohol dependence, and infection with oncogenic viruses such as human Papilloma virus (HPV) are among the risk factors for development of these tumors. Currently, the main treatment of nasopharyngeal and hypopharyngeal carcinomas is radio-chemotherapy based in histological type, grade and stages of the tumors

Tumor infiltrating lymphocytes (TILs) are considered as cornerstone in cancer immunotherapy and as a biomarker with effectiveness predictive value. The intensity and quality of immune cells, especially lymphocytes, in tumor microenvironment are strongly related to the outcome of immune checkpoint blockade therapy .

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: immunohistochemical

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Expression of Programmed Death Ligand-1 (PD-L1) in Nasopharyngeal and Hyypopharyngeal Carcinoma
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Outcome Measures

Primary Outcome Measures

  1. expression of programmed death ligand-1 (PD-L1) in nasopharyngeal and hypopharyngeal carcinoma [12 months]

    evaluate expression of PD-L1 in nasopharyngeal and hypopharyngeal carcinomas and to correlate its expression to different clinical and histopathological parameters to address its prognostic value.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patients with nasopharyngeal and hypopharyngeal carcinomas who underwent diagnostic biopsies.
Exclusion Criteria:
  • Patients received chemotherapy or radiotherapy.

  • Patients with insufficient clinical data.

  • Specimens with extensive necrosis

  • Tiny specimens which are insufficient for accurate diagnosis.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nahaweend Mohamed Hafez, demonstrator, pathology department, faculty of medicine, sohag university, Sohag University
ClinicalTrials.gov Identifier:
NCT05595265
Other Study ID Numbers:
  • Soh_Med_22_10_20
First Posted:
Oct 26, 2022
Last Update Posted:
Oct 26, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2022