Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 8:34 AM
Study NCT ID:
NCT04189003
Status:
COMPLETED
Last Update Posted:
2021-10-04
First Post:
2019-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Signatures of HPV+ ORL Cancers (OROPAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Frozen and/or FFPE biopsies of HPV-positive oropharyngeal tumors and frozen blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-01', 'studyFirstSubmitDate': '2019-10-18', 'studyFirstSubmitQcDate': '2019-12-04', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': '18 months', 'description': 'Establish a new classification based on HPV molecular signature for positive human papillomavirus oropharyngeal tumor'}], 'secondaryOutcomes': [{'measure': 'Quantification of HPV circulating tumoral DNA in peripheral blood by droplet based digital PCR', 'timeFrame': '18 months', 'description': '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'}, {'measure': 'Correlate identified HPV molecular signature with clinical-anatomo-pathological data.', 'timeFrame': '18 months', 'description': 'Look for an association between the presence of specific HPV molecular signatures and clinical-anatomo-pathological data.'}, {'measure': 'Number of Death of any cause, or eventual relapse', 'timeFrame': '18 months', 'description': 'Look for an association between the presence of these molecular signatures and the survival of patients.'}, {'measure': 'Ratio of the number of copies of viral genes to the number of cells', 'timeFrame': '18 months', 'description': 'Measure the viral load of HPV in the tumor.'}, {'measure': 'Precise description of HPV insertion localisation in human genome when HPV is integrated', 'timeFrame': '18 months', 'description': 'Identify disrupted metabolic pathways in tumor cells.'}, {'measure': 'Description of new HPV viral variants based on complete HPV genome sequencec obtained by Capture-HPV coupled with NGS', 'timeFrame': '18 months', 'description': 'Analyze of complete viral genomes and identify potential variants through sequencing data analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ORL Cancers', 'HPV+ tumor', 'molecular signature', 'human papillomavirus'], 'conditions': ['Oropharyngeal Cancer', 'Human Papillomavirus-Related Carcinoma']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'OROPAP is a monocentric exploratory study with retrospective inclusion of patients.\n\nThe retrospective study focus on patients who have had surgery for HPV-positive oropharyngeal tumors whose survival is at least 2 year.\n\nFrozen and or FFPE biopsies of these tumors and frozen blood samples are available via the HEGP biological resources platform.\n\nThe HPV molecular signatures will be identified by the capture-HPV technique.\n\nFor 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with HPV-induced oropharyngeal cancer with survival follow-up greater than 2 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with HPV + oropharyngeal cancer\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT04189003', 'acronym': 'OROPAP', 'briefTitle': 'Molecular Signatures of HPV+ ORL Cancers (OROPAP)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Identification of Specific Molecular Signatures by Capture-HPV and Next-generation Sequencing in HPV-induced Oropharyngeal Cancers', 'orgStudyIdInfo': {'id': 'APHP180166'}, 'secondaryIdInfos': [{'id': 'APHP180166', 'type': 'OTHER', 'domain': 'AP-HP'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Hélène PÉRÉ, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AP-HP, Hôpital Européen Georges Pompidou'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'one year after the last publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie results in publication could be shared. Individual participant data detailed in meta analysis protocol could be shared', 'accessCriteria': 'Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team.\n\nTeams 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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}