Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-07 @ 11:40 PM
Study NCT ID:
NCT01984359
Status:
COMPLETED
Last Update Posted:
2020-04-10
First Post:
2013-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HPV Serum DNA Levels Predicting Outcome in p16+ Squamous Cell Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-09', 'studyFirstSubmitDate': '2013-11-08', 'studyFirstSubmitQcDate': '2013-11-08', 'lastUpdatePostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with Adverse Events', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Subjects With p16 Positive/HPV Positive Squamous Cell Carcinomas of the Oropharynx']}, 'descriptionModule': {'briefSummary': 'To assess in an exploratory manner, the pronostic utility for locoregional control, progression-free and distant metastasis-free survival of a pre-therapy and post-therapy blood DNA test of HPV E6 and E7 DNA for subtypes 16 and 18 in p16+ and/or HPV+ oropharyngeal cancer patients. This will entail analysis of both initial pre-therapy HPV level as a continuous variable and initial post-therapy HPV level as a dichotomous variable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histoloically proven primary cancer of the oropharynx, p16(+) and/or HPV (+), who are planned for treatment with resection, radiation and/or chemotherapy.\n* Subsites of oropharynx:include tonsil, base of tongue, vallecula, oropharyngeal wall, soft palate, glossotonsillar sulcus.\n* No or minimal smoking history (\\</= 10 pack-year, no smoking in the past 12 months last 10 years based on documented history and/or subject report)\n* Age 18 years or older\n* Subjects are capable of giving informed consent or have an acceptabl;e surrogate capable of giving consent on the subjects behalf.\n* Enrollment on any other study, regardless of therapy is allowed.\n* Enrollment on any other tumor or tissue banking study is allowed.\n* Patients who have had blood drawn as part of another study, including the IRB-approved ENT Tumor Bank Study, may be included in this study even if the patient has already had surgery.\n\nExclusion Criteria:\n\n* Previous chemotherapy or radiation therapy to the head and neck unrelated to current disease.\n* Previous surgery for head and neck cancer unrelated to current disease.\n* Widespread , biopsy-proven metastatic disease (stage IVC disease) at time of presentation (small indeterminate lung or mediastinal nodules are allowed)\n* Patients who have started induction chemotherapy prior to consideration for study eligibility.\n* Another active cancer except nonmelanomatous skin cancer.\n* History of cervical penile or anal cancer.\n* Patient treated with surgery, adjuvant radiation therapy or chemotherapy outside of the University of Pennsylvania.\n* History of smoking in the past last 12 months 10 years\n* History of 10 pack-years of cigarette smoking based on documented history and/or subject report\n* Presence of sidespread leukoplakia or erythroplakia.'}, 'identificationModule': {'nctId': 'NCT01984359', 'briefTitle': 'HPV Serum DNA Levels Predicting Outcome in p16+ Squamous Cell Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'A Pilot, Single-Center Study Of Quantitative HPV Serum Or Plasma DNA As A Prognostic Marker In P16+/HPV+ Squamous Carcinomas Of The Oropharynx And Unknown Primary Head And Neck Cancers', 'orgStudyIdInfo': {'id': 'UPCC 22313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single arm', 'description': 'Biosamples will be obtained at multiple time-points for all participants', 'interventionNames': ['Other: Obtaining Human tissue']}], 'interventions': [{'name': 'Obtaining Human tissue', 'type': 'OTHER', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Peter Ahn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}