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HPV Serum DNA Levels Predicting Outcome in p16+ Squamous Cell Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT01984359
Recruitment Status : Unknown
Verified September 2016 by Abramson Cancer Center of the University of Pennsylvania.
Recruitment status was:  Recruiting
First Posted : November 14, 2013
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Subjects With p16+/HPV+ Squamous Cell Carcinomas of the Oropharynx. Other: Obtaining Human tissue Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : May 2013
Estimated Primary Completion Date : May 2017



Primary Outcome Measures :
  1. Number of subjects with Adverse Events [ Time Frame: 4 years ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histoloically proven primary cancer of the oropharynx, p16(+) and/or HPV (+), who are planned for treatment with resection, radiation and/or chemotherapy.
  • Subsites of oropharynx:include tonsil, base of tongue, vallecula, oropharyngeal wall, soft palate, glossotonsillar sulcus.
  • 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)
  • Age 18 years or older
  • Subjects are capable of giving informed consent or have an acceptabl;e surrogate capable of giving consent on the subjects behalf.
  • Enrollment on any other study, regardless of therapy is allowed.
  • Enrollment on any other tumor or tissue banking study is allowed.
  • 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.

Exclusion Criteria:

  • Previous chemotherapy or radiation therapy to the head and neck unrelated to current disease.
  • Previous surgery for head and neck cancer unrelated to current disease.
  • Widespread , biopsy-proven metastatic disease (stage IVC disease) at time of presentation (small indeterminate lung or mediastinal nodules are allowed)
  • Patients who have started induction chemotherapy prior to consideration for study eligibility.
  • Another active cancer except nonmelanomatous skin cancer.
  • History of cervical penile or anal cancer.
  • Patient treated with surgery, adjuvant radiation therapy or chemotherapy outside of the University of Pennsylvania.
  • History of smoking in the past last 12 months 10 years
  • History of 10 pack-years of cigarette smoking based on documented history and/or subject report
  • Presence of sidespread leukoplakia or erythroplakia.

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): NCT01984359


Contacts
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Contact: Peter Ahn, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Peter Ahn, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Peter Ahn, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Peter Ahn, MD Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01984359     History of Changes
Other Study ID Numbers: UPCC 22313
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases