Molecular Signatures of HPV+ ORL Cancers (OROPAP)
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 [18 months]
Establish a new classification based on HPV molecular signature for positive human papillomavirus oropharyngeal tumor
Secondary Outcome Measures
- Quantification of HPV circulating tumoral DNA in peripheral blood by droplet based digital PCR [18 months]
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
- Correlate identified HPV molecular signature with clinical-anatomo-pathological data. [18 months]
Look for an association between the presence of specific HPV molecular signatures and clinical-anatomo-pathological data.
- Number of Death of any cause, or eventual relapse [18 months]
Look for an association between the presence of these molecular signatures and the survival of patients.
- Ratio of the number of copies of viral genes to the number of cells [18 months]
Measure the viral load of HPV in the tumor.
- Precise description of HPV insertion localisation in human genome when HPV is integrated [18 months]
Identify disrupted metabolic pathways in tumor cells.
- Description of new HPV viral variants based on complete HPV genome sequencec obtained by Capture-HPV coupled with NGS [18 months]
Analyze of complete viral genomes and identify potential variants through sequencing data analysis
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with HPV + oropharyngeal cancer
Exclusion Criteria:
- NA
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Européen Georges Pompidou | Paris | Ile-de-France | France | 75015 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Study Director: Hélène PÉRÉ, PhD, AP-HP, Hôpital Européen Georges Pompidou
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APHP180166
- APHP180166