A Study Using Human Papillomavirus (HPV) DNA Testing to Detect HPV-Related Oropharyngeal Cancer (OPC)

Study Results

Results pending

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.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-31

Study Completion Date

2031-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The researchers think that a blood test (NavDx®) may be able to identify cancer early by looking for circulating DNA from Human Papillomavirus/HPV. Circulating DNA are small pieces of genes that are released into the bloodstream. The purpose of this study is to find out whether using this blood test to test for HPV DNA will help detect HPV-related Oropharyngeal Cancer/OPC.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Improving Detection and Early Action for HPV-positive Oropharynx Cancer

NCT04871490

HPV Positive Oropharyngeal Squamous Cell Carcinoma

COMPLETED NA

Post-treatment Surveillance in HPV+ Oropharyngeal SCC

NCT04965792

HPV Oropharyngeal Squamous Cell Carcinoma

ACTIVE_NOT_RECRUITING

HPV Serum DNA Levels Predicting Outcome in p16+ Squamous Cell Head and Neck Cancer

NCT01984359

Subjects With p16 Positive/HPV Positive Squamous Cell Carcinomas of the Oropharynx

COMPLETED NA

Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers

NCT05606133

Cervical Dysplasia Cervical Cancer

RECRUITING NA

Application of Plasma Circulating HPV DNA Testing to Management of Cervical Intraepithelial Neoplasia

NCT04274465

Cervix Lesion Cervical Cancer

COMPLETED

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.

Oropharyngeal Cancer HPV-Related Carcinoma HPV Positive Oropharyngeal Squamous Cell Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No previous history of diagnosed HPV-related head and neck cancer

Participants have no previous history of diagnosed HPV-related head and neck cancer

NavDx

Intervention Type DIAGNOSTIC_TEST

Evaluation of HPV presence via NavDx (v1) at two (or three) timepoints

o If one of the two blood samples is positive, the subject will have a third NavDx (v1) test approximately 1 month after the second timepoint. If the test is positive, the subject will move to surveillance phase.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NavDx

Evaluation of HPV presence via NavDx (v1) at two (or three) timepoints

o If one of the two blood samples is positive, the subject will have a third NavDx (v1) test approximately 1 month after the second timepoint. If the test is positive, the subject will move to surveillance phase.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ages 45 and older
* Self-reported history of four or more lifetime sexual partners
* Self-reported history of one or more lifetime oral sexual partner
* No previous history of diagnosed HPV-related head and neck cancer