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

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ClinicalTrials.gov Identifier: NCT03580070
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
European Georges Pompidou Hospital
Information provided by (Responsible Party):
University Hospital Center of Martinique

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
Immunotherapy 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.

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Study Type : Observational
Estimated 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 : December 7, 2017
Actual Primary Completion Date : December 7, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: 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


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. [ Time Frame: 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 [ Time Frame: 12 months ]
    Automated reading of results by software Inform (Perkin©).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580070


Contacts
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Contact: Mickaëlle ROSE +596 596 59 26 23 mickaelle.rose@chu-martinique.fr

Locations
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France
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Mickaëlle ROSE    +596596592623    mickaelle.rose@chu-martinique.fr   
Principal Investigator: Cécile BADOUAL, Pr         
Martinique
CHU Martinique Recruiting
Fort-de-France, Martinique, 97261
Contact: Mickaëlle ROSE    +596596592623    mickaelle.rose@chu-martinique.fr   
Principal Investigator: Vincent MOLINIE, Pr         
Sponsors and Collaborators
University Hospital Center of Martinique
European Georges Pompidou Hospital
Investigators
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Principal Investigator: Vincent MOLINIE, Pr CHU Martinique

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Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT03580070     History of Changes
Other Study ID Numbers: 17/E/13
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Head cancers
Neck squamous cells carcinoma
HPV
Immunotherapy

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Immunologic Factors
Physiological Effects of Drugs