Clinical trial NCT03580070: Changes in the Microenvironment of HPV-induced Head and Neck Cancers in West Indies and Metropolitan Population
Official title: Automated Multiparameter in Situ Study Comparing the Microenvironment of Head and Neck Cancers Among West Indies and Metropolitan Populations: Screening for Predictive Markers of Overall Survival and Immunotherapy Responses.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunotherapy
Keywords: Head cancers
Neck squamous cells carcinoma
HPV
Immunotherapy
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
Collaborators: name: European Georges Pompidou Hospital
First posted: 2018-07-09
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Primitive head and neck squamous cells carcinoma diagnosed on surgical resection or biopsic sample, between 2008 and 2015 in metropolitan and Antillean populations. For metropolitan they were included when expressing p16 as assessed by immunochemistry and positive HPV DNA by in situ hybridation or positive HPV PCR. For Antillean population they were included when expressing p16 as assessed by immunochemistry with regards of genotype as assessed by in situ hybridation or by PCR (to be completed).

Exclusion Criteria:

* Secondary tumors,
* Tumor recurrence in a patient for whom we have already tumor tissue, nasopharyngeal tumors, p16 expression by immunochemistry with negative PCR testing for HPV.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Fort-de-France
country: Martinique
facility: CHU Martinique
Study officials:
affiliation: CHU Martinique
name: Vincent MOLINIE, Pr
role: PRINCIPAL_INVESTIGATOR
References: