Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer

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Wake Forest University (WFU)

Status

Begins enrollment this month

Conditions

Human Papillomavirus Infection
Oropharyngeal Squamous Cell Carcinoma

Treatments

Genetic: Pre-Radiation Dental Evaluation/Sample Collection
Genetic: Oral Medicine Consultation Visit/Sample Collection
Other: Pre-Study Visit

Study type

Observational

Funder types

Other

Identifiers

NCT06362421
ONC-HN-2402

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

39 to 59 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

80 participants in 2 patient groups

Treatment naive patients with HPV+ OPSCC
Description:
Participants will receive a pre-study visit and pre-radiation dental evaluation.
Treatment:
Other: Pre-Study Visit
Genetic: Pre-Radiation Dental Evaluation/Sample Collection
Control Group - Healthy subjects without cancer
Description:
Participants will receive a pre-study visit and oral medicine consultation visit.
Treatment:
Other: Pre-Study Visit
Genetic: Oral Medicine Consultation Visit/Sample Collection

Trial contacts and locations

2

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Central trial contact

Study Coordinator

Data sourced from clinicaltrials.gov

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