Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer
NCT ID: NCT06362421
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
OBSERVATIONAL
2025-08-31
2026-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Feasibility of HPV Testing With Mail-delivered Sample Collection Kits
NCT07087145
Monitoring of Oral Human Papillomavirus Infection (HPV) in HPV-positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)
NCT02045186
Prevalence of Human Papillomavirus (HPV) in a Healthy Population: A Feasibility Study of Oropharyngeal Cancer Screening
NCT07033091
Validity of Viome's Oral/throat Cancer Test
NCT06174428
Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time
NCT01342978
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment naive patients with HPV+ OPSCC
Participants will receive a pre-study visit and pre-radiation dental evaluation.
Pre-Radiation Dental Evaluation/Sample Collection
Collection of saliva samples and mouth swabs and pre-cancer dental evaluation by study staff. Unstimulated saliva will be collected then a buccal swab sample will be obtained. Participants will be asked to rinse their mouth with water, wait 10 minutes, then 1-2 mL of unstimulated saliva will be captured into sterile centrifuge tube. Next, a buccal swab sample will be collected using a sterile cotton swab and immediately placed in a transport tube containing buffer (Tris with low EDTA)
Pre-Study Visit
Collection of vital signs, medical history and current medications
Control Group - Healthy subjects without cancer
Participants will receive a pre-study visit and oral medicine consultation visit.
Pre-Study Visit
Collection of vital signs, medical history and current medications
Oral Medicine Consultation Visit/Sample Collection
Collection of saliva samples and mouth swab, complete oral medicine consultation by study staff. Unstimulated saliva will be collected then a buccal swab sample will be obtained. Participants will be asked to rinse their mouth with water, wait 10 minutes, then 1-2 mL of unstimulated saliva will be captured into sterile centrifuge tube. Next, a buccal swab sample will be collected using a sterile cotton swab and immediately placed in a transport tube containing buffer (Tris with low EDTA)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pre-Radiation Dental Evaluation/Sample Collection
Collection of saliva samples and mouth swabs and pre-cancer dental evaluation by study staff. Unstimulated saliva will be collected then a buccal swab sample will be obtained. Participants will be asked to rinse their mouth with water, wait 10 minutes, then 1-2 mL of unstimulated saliva will be captured into sterile centrifuge tube. Next, a buccal swab sample will be collected using a sterile cotton swab and immediately placed in a transport tube containing buffer (Tris with low EDTA)
Pre-Study Visit
Collection of vital signs, medical history and current medications
Oral Medicine Consultation Visit/Sample Collection
Collection of saliva samples and mouth swab, complete oral medicine consultation by study staff. Unstimulated saliva will be collected then a buccal swab sample will be obtained. Participants will be asked to rinse their mouth with water, wait 10 minutes, then 1-2 mL of unstimulated saliva will be captured into sterile centrifuge tube. Next, a buccal swab sample will be collected using a sterile cotton swab and immediately placed in a transport tube containing buffer (Tris with low EDTA)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* Age 39 to 59 years.
* Ability to understand and the willingness to sign an IRB-approved informed consent document directly.
Exclusion Criteria
* Patients with current or previous diagnosis with HPV+ infection status for cervical cancer or other cancers.
* 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.
39 Years
59 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
InnoTech Precision Medicine
UNKNOWN
Wake Forest University Health Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ONC-HN-2402
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00115786
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.