Changes in the Microenvironment of HPV-induced Head and Neck Cancers in West Indies and Metropolitan Population

NCT ID: NCT03580070

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-07
• Study Completion Date: 2019-12-31

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.

Conditions

Immunotherapy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

Immunotherapy

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Georges Pompidou Hospital

OTHER

Sponsor Role: collaborator

University Hospital Center of Martinique

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent MOLINIE, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Martinique

Locations

Hôpital Européen Georges Pompidou

Paris, , France

CHU Martinique

Fort-de-France, , Martinique

Countries

France; Martinique

Other Identifiers

17/E/13

Identifier Type: -

Identifier Source: org_study_id