Clinical trial NCT06362421: Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer
Official title: Proof of Concept Assay Development of Point of Care Saliva Testing for High Risk-HPV Oral Cavity and Pharynx Cancers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Oropharyngeal Squamous Cell Carcinoma
Human Papillomavirus Infection
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: InnoTech Precision Medicine
First posted: 2024-04-12
Enrollment: 80
Sex: ALL
Minimum age (years): 39
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Head and Neck oncology team and navigators, as well as tumor board meetings, will be leveraged to identify and recruit newly diagnosed patients.

Participants in the healthy control group will be identified and recruited and enrolled after patients in the research cohort (those with OPSCC) participants have been enrolled.

Brief summary: The purpose of this research study is to determine if saliva and oral swab samples can be used to detect human papillomavirus in patients with cancer. In this study, the methods required to detect human papillomavirus will be developed and tested in samples collected from patients with oropharyngeal squamous cell carcinoma and compared to samples collected from participants without cancer.

Detailed description: To validate the detection of human papillomavirus 16 and 18 and reference gene ACTB in saliva and buccal swab samples obtained from patients with oropharyngeal squamous cell carcinoma (OPSCC) using the LAMP/CRISPR/electrochemical workflow.

Eligibility criteria: Inclusion Criteria (Patients with Cancer);

* Patients must have histologically confirmed oropharyngeal squamous cell carcinoma without prior treatment. A pathology report should be referenced/available.
* Patients with p16 positive oropharyngeal squamous cell carcinoma.
* Age 39 to 59 years.
* Ability to understand and the willingness to sign an IRB-approved informed consent document directly.

Inclusion Criteria (Healthy Subjects)

* Age 39 to 59 years.
* Ability to understand and the willingness to sign an IRB-approved informed consent document directly.

Exclusion Criteria (Patients with Cancer)

* Patients with diagnoses of other cancers.
* Patients with current or previous diagnosis with HPV+ infection status for cervical cancer or other cancers.

Exclusion Criteria (Healthy Subjects)

* Previous diagnosis of cervical cancer or other cancers.
* Presence of known active oral infections of viral, fungal, or bacterial etiology except for gingivitis, periodontitis, or periapical abscess. Participants with known gingivitis, periodontitis, or periapical abscess are included.

Primary outcomes:
measure: Number of Participants with Sensitivity for Detection of HPV 16, 18 and gene ACTB
timeFrame: Up to 2 years
measure: Number of Participants with Specificity Detection of HPV 16, 18 and gene ACTB
timeFrame: Up to 2 years
measure: Overall Accuracy - All Participants
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: High Point
country: United States
facility: Hayworth Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
References: