An observational study in Immunotherapy, sponsored by University Hospital Center of Martinique. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-17.
Sponsored by University Hospital Center of Martinique · Observational
Retrospective observational comparative and multicentric study of the microenvironment of HPV-induced head and neck cancers, with comparison between West Indies and Metropolitan populations, and therapeutic implications. This assessment is carried out by in situ multiparametric study with multiple immunofluorescence staining for cluster of differentiation 3, cluster of differentiation 4, cluster of differentiation 8, PROGRAMMED DEATH-1, PROGRAMMED DEATH-L1, PROGRAMMED DEATH-L2, cytokeratin and cluster of differentiation 68 and automated reading. HPV genotypes will be characterized. Learning these techniques will allow me to promote them in West Indies on my way back, and they may be applicable to other HPV-induced cancers.
Global annual incidence of head and neck (HN) cancers is high. It is even a greater concern in West Indies compared to other American countries. Most represented histological type is squamous carcinoma and several risk factors are involved , including tobacco exposure. Moreover, it is now clear that Human Papillomavirus (HPV) is a causal factor in the development of HNSCCs : as many as 5 to 10% of tumors are induced by HPV in the world, and it is responsible of 25,9% of HN tumors. HPV 16 is the most involved (87%). However, HPV epidemiology is different in West Indies with the implication of various genotypes. Detection of HPV infection can be achieved through several methods such as polymerase chain reaction (PCR) or RNAscope, which is a new reliable precise technique which reflects the transcriptional activity of the virus. The differences between the genotype of HPV involved within both populations need to be consider to better identify therapeutic targets.Studying the microenvironment may allow a better understanding of anti-tumoral immunity and may help patient selection in order to achieved better responses to immunotherapy.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 140 is above the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University Hospital Center of Martinique is the lead sponsor of 77 studies on the registry; 20 are open to participants now.
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Patient with primitive head and neck squamous cells carcinoma diagnosed on surgical resection or biopsic sample, between 2008 and 2015 in metropolitan and Antillean populations
Exclusion Criteria:
Patients with primitive head and neck squamous cells carcinoma diagnosed on surgical resection or biopsic sample, between 2008 and 2015. They were included when expressing p16 as assessed by immunochemistry and positive HPV DNA by in situ hybridation or positive HPV PCR
Description of tumoral microenvironment with multiparametric study by immunofluorescence comparing West Indies population and metropolitan population and the stratification of patients regarding RNAscope staining intensity and HPV genotype.
Automated reading of results by software Inform (Perkin©).
Time frame: 12 months
The secondary outcome measures are: - interpretation of RNAscope results and comparison between West Indies and Metropolitan population, - evaluation of RNAscope staining intensity to define subgroups
Automated reading of results by software Inform (Perkin©).
Time frame: 12 months
Plan to share: No
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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University Hospital Center of Martinique