Subjects With p16 Positive/HPV Positive Squamous Cell Carcinomas of the Oropharynx Clinical Trial
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
| NCT number | NCT01984359 |
| Other study ID # | UPCC 22313 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2013 |
| Est. completion date | May 24, 2018 |
| Verified date | April 2020 |
| Source | Abramson Cancer Center of the University of Pennsylvania |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | May 24, 2018 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of subjects with Adverse Events | 4 years |