Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT01984359
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01984359
Study Brief:
Protocol Section:
NCT01984359