Clinical trial NCT05595265: Expression of Programmed Death Ligand-1 (PD-L1) in Nasopharyngeal and Hyypopharyngeal Carcinoma
Official title: Expression of Programmed Death Ligand-1 (PD-L1) in Nasopharyngeal and Hyypopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal and Hypopharyngeal Carcinoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - Patients with nasopharyngeal and hypopharyngeal carcinomas who underwent diagnostic biopsies.

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 .


Eligibility criteria: 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.

Primary outcomes:
measure: expression of programmed death ligand-1 (PD-L1) in nasopharyngeal and hypopharyngeal carcinoma
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
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citation: Mehanna H, Beech T, Nicholson T, El-Hariry I, McConkey C, Paleri V, Roberts S. Prevalence of human papillomavirus in oropharyngeal and nonoropharyngeal head and neck cancer--systematic review and meta-analysis of trends by time and region. Head Neck. 2013 May;35(5):747-55. doi: 10.1002/hed.22015. Epub 2012 Jan 20.
citation: Willenbrink TJ, Ruiz ES, Cornejo CM, Schmults CD, Arron ST, Jambusaria-Pahlajani A. Field cancerization: Definition, epidemiology, risk factors, and outcomes. J Am Acad Dermatol. 2020 Sep;83(3):709-717. doi: 10.1016/j.jaad.2020.03.126. Epub 2020 May 7.
citation: Paijens ST, Vledder A, de Bruyn M, Nijman HW. Tumor-infiltrating lymphocytes in the immunotherapy era. Cell Mol Immunol. 2021 Apr;18(4):842-859. doi: 10.1038/s41423-020-00565-9. Epub 2020 Nov 2.