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

Sponsor
University Hospital Center of Martinique (Other)
Overall Status
Completed
CT.gov ID
NCT03580070
Collaborator
European Georges Pompidou Hospital (Other)
140
2
12.8
70
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Immunotherapy

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.

Study Design

Study Type:
Observational
Actual Enrollment :
140 participants
Observational Model:
Other
Time Perspective:
Retrospective
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.
Actual Study Start Date :
Dec 7, 2018
Actual Primary Completion Date :
Oct 19, 2019
Actual Study Completion Date :
Dec 31, 2019

Outcome Measures

Primary Outcome Measures

  1. 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. [12 months]

    Automated reading of results by software Inform (Perkin©).

Secondary Outcome Measures

  1. 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 [12 months]

    Automated reading of results by software Inform (Perkin©).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Européen Georges Pompidou Paris France 75015
2 CHU Martinique Fort-de-France Martinique 97261

Sponsors and Collaborators

  • University Hospital Center of Martinique
  • European Georges Pompidou Hospital

Investigators

  • Principal Investigator: Vincent MOLINIE, Pr, CHU Martinique

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Center of Martinique
ClinicalTrials.gov Identifier:
NCT03580070
Other Study ID Numbers:
  • 17/E/13
First Posted:
Jul 9, 2018
Last Update Posted:
Feb 17, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital Center of Martinique
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2020