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| ID | Type | Description | Link |
|---|---|---|---|
| APHP180166 | Other Identifier | AP-HP |
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The aim of this study is to identify HPV molecular signature in head and neck cancer to establish a new classification for positive human papillomavirus oropharyngeal tumor
OROPAP is a monocentric exploratory study with retrospective inclusion of patients.
The retrospective study focus on patients who have had surgery for HPV-positive oropharyngeal tumors whose survival is at least 2 year.
Frozen and or FFPE biopsies of these tumors and frozen blood samples are available via the HEGP biological resources platform.
The HPV molecular signatures will be identified by the capture-HPV technique.
For each patient, clinical-anatomo-pathological data such as tumor size, tumor stage, presence or absence of metastasis, histological stage, different treatment lines and 2-years survival data will be collected through the use of data warehouse available on the HEGP.
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| Measure | Description | Time Frame |
|---|---|---|
| Description the HPV molecular signatures identified by the Capture-HPV technique and comparison of these signatures with those already described in the classification described in the Holmes et al. in the cervix | Establish a new classification based on HPV molecular signature for positive human papillomavirus oropharyngeal tumor | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of HPV circulating tumoral DNA in peripheral blood by droplet based digital PCR | Find in the peripheral blood of patients, the presence of circulating tumoral HPV DNA (ctDNA) by droplet based digital PCR and when it is possible compare chromosomal insertion patterns of HPV ct DNA as those found in tumors | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with HPV-induced oropharyngeal cancer with survival follow-up greater than 2 years
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| Name | Affiliation | Role |
|---|---|---|
| Hélène PÉRÉ, PhD | AP-HP, Hôpital Européen Georges Pompidou | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Européen Georges Pompidou | Paris | Île-de-France Region | 75015 | France |
Individual participant data that underlie results in publication could be shared. Individual participant data detailed in meta analysis protocol could be shared
one year after the last publication
Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team.
Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization
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| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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Frozen and/or FFPE biopsies of HPV-positive oropharyngeal tumors and frozen blood sample
| Correlate identified HPV molecular signature with clinical-anatomo-pathological data. |
Look for an association between the presence of specific HPV molecular signatures and clinical-anatomo-pathological data. |
| 18 months |
| Number of Death of any cause, or eventual relapse | Look for an association between the presence of these molecular signatures and the survival of patients. | 18 months |
| Ratio of the number of copies of viral genes to the number of cells | Measure the viral load of HPV in the tumor. | 18 months |
| Precise description of HPV insertion localisation in human genome when HPV is integrated | Identify disrupted metabolic pathways in tumor cells. | 18 months |
| Description of new HPV viral variants based on complete HPV genome sequencec obtained by Capture-HPV coupled with NGS | Analyze of complete viral genomes and identify potential variants through sequencing data analysis | 18 months |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |