Nasopharyngeal and Hypopharyngeal CarcinomaNCT05595265
Expression of Programmed Death Ligand-1 (PD-L1) in Nasopharyngeal and Hyypopharyngeal Carcinoma
An observational study of Nasopharyngeal and Hypopharyngeal Carcinoma, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nasopharyngeal and Hypopharyngeal Carcinoma
- What is being tested?
- immunohistochemical
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2022to Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: - Patients with nasopharyngeal and hypopharyngeal carcinomas who underwent diagnostic biopsies.
Who may be able to join
- Patients with nasopharyngeal and hypopharyngeal carcinomas who underwent diagnostic biopsies.
Who cannot join
- Patients received chemotherapy or radiotherapy.
- Patients with insufficient clinical data.
- Specimens with extensive necrosis
- Tiny specimens which are insufficient for accurate diagnosis.
Trial locations and contacts
1 site in 1 country.
ahmed r hamed, professor contact
About this study
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 .
- Being tested
- immunohistochemical
- Medical subject headings
- Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunohistochemicalDiagnostic test
Immunohistochemical Evaluation: Corresponding sections of 4µm thickness from each Formalin-fixed paraffin blocks will be immunohistochemically stained by anti- PD-L1 antibody according to the recommended protocol.
What is being measured
The primary outcome is the main question the study is designed to answer.
expression of programmed death ligand-1 (PD-L1) in nasopharyngeal and hypopharyngeal carcinoma
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study startNov 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal and Hypopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahaweend Mohamed Hafez, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595265
- Sponsor's protocol ID
- Soh_Med_22_10_20
- Status last verified
- Oct 2022
- First submitted
- 23 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
PubMed 25328522Mehanna 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.
PubMed 22267298Willenbrink 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.
PubMed 32387665Paijens 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.
PubMed 33139907
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Programmed Death Ligand-1 (PD-L1) in Nasopharyngeal and Hyypopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT05595265
- Acronym / sponsor ID
- Soh_Med_22_10_20
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- - Patients with nasopharyngeal and hypopharyngeal carcinomas who underwent diagnostic biopsies.
Key inclusion criteria (1 listed)
- Patients with nasopharyngeal and hypopharyngeal carcinomas who underwent diagnostic biopsies.
Key exclusion criteria (4 listed)
- Patients received chemotherapy or radiotherapy.
- Patients with insufficient clinical data.
- Specimens with extensive necrosis
- Tiny specimens which are insufficient for accurate diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunohistochemicalImmunohistochemical Evaluation: Corresponding sections of 4µm thickness from each Formalin-fixed paraffin blocks will be immunohistochemically stained by anti- PD-L1 antibody according to the recommended protocol. | Diagnostic test | – |
Primary outcome
expression of programmed death ligand-1 (PD-L1) in nasopharyngeal and hypopharyngeal carcinoma
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Background: PubMed 25328522Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
- Background: PubMed 22267298Mehanna 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.
- Background: PubMed 32387665Willenbrink 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.
- Background: PubMed 33139907Paijens 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed r hamed, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal and Hypopharyngeal Carcinoma, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nahawand m hafez, demonstrator (01008141816, nahawendmohammed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expression of programmed death ligand-1 (PD-L1) in nasopharyngeal and hypopharyngeal carcinoma (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05595265, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.