Biomarker Panel for Early Detection of Oropharyngeal Cancer

(BASH OPC Trial)

Recruiting at 1 trial location

Overseen By Kimberly Isaacs-Soriano

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Previous HNC, HPV-related cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new method for detecting early signs of oropharyngeal cancer, which affects the throat. Researchers are evaluating whether a special oral test can accurately identify cancer by detecting specific DNA and gene changes. Participants will include individuals with early or late-stage oropharyngeal cancer and healthy individuals matched by factors such as smoking habits and demographics. This trial may suit those recently diagnosed with oropharyngeal cancer who have not yet received treatment. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to earlier detection of oropharyngeal cancer.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this biomarker panel is safe for use in detecting Oropharyngeal Cancer?

Research has shown that a new test, which examines specific DNA changes, might help detect oropharyngeal cancer (OPC) early. This test identifies DNA changes linked to cancer.

Studies have primarily assessed the test's ability to distinguish between individuals with early OPC and those without it. In one study, the test correctly identified 70.3% of individuals with the disease (sensitivity) and 90.9% of individuals without the disease (specificity). Sensitivity measures how well the test detects those with the disease, while specificity measures how well it identifies those without it.

These studies have reported no harmful effects. As a diagnostic test, not a treatment, it mainly involves collecting samples like oral swabs, which are generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BASH OPC trial because it explores a new way to detect HPV-related oropharyngeal cancer early using biomarkers. Unlike traditional methods, which often rely on noticeable symptoms or invasive procedures for diagnosis, this approach aims to identify cancer earlier and more accurately by analyzing specific biological markers in the body. This could lead to earlier interventions and better outcomes for patients, potentially transforming the current standard of care.

What evidence suggests that this biomarker panel is effective for distinguishing early Oropharyngeal Cancer?

This trial will evaluate a new test that combines HPV 16 DNA with changes in the EPB41L3 gene to help detect early throat cancer. Research has shown that specific DNA changes in HPV and EPB41L3 can distinguish between individuals with throat cancer and healthy individuals. Participants in the trial may receive this test, which can effectively identify early cases of throat cancer by detecting these changes in mouth samples. Using both HPV 16 DNA and gene changes together offers a promising method for early throat cancer screening. ^{1 2 3 4 6}

Who Is on the Research Team?

Antonio Amelio, PhD

Principal Investigator

Moffitt Cancer Center

Anna Giuliano, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I have given my written consent to participate in the MCC 17716 study or am enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center.

I am 35 years old or older.

I have never been diagnosed with head, neck, or HPV-related cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biomarker Testing

Participants undergo testing for HPV 16 DNA and host gene methylation to distinguish early Oropharyngeal Cancer cases from controls

Up to 60 months

Follow-up

Participants are monitored for diagnostic specificity and sensitivity outcomes

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Combined HPV 16 DNA and host gene methylation oral biomarker panel

How Is the Trial Designed?

Group I: Control Group Experimental Treatment 1 Intervention

Controls will be enrolled from members of the catchment area to ensure geographic comparability of cases and controls. Controls will be matched by sex, age, race/ethnicity, and tobacco use.

Group II: Case Group Experimental Treatment 1 Intervention

Case group will consist of early and late disease pre-treatment Oropharyngeal Cancer cases.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9582688/

Methylation of HPV16 and EPB41L3 in oral gargles ... The ability of HPV16/EPB41L3 methylation to distinguish OPC from healthy controls highlights its utility as a potential biomarker for OPC.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06305676

Biomarker Approach to Screening for the Early Detection of ... Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early ...

3. aacrjournals.org aacrjournals.org/cancerpreventionresearch/article/17/4/169/741883/Identification-of-a-Biomarker-Panel-from-Genome

Identification of a Biomarker Panel from Genome-Wide ... This study identified biomarkers using genome-wide methylation to create a panel capable of discerning early oropharyngeal cancer (OPC) from those without.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666679024000090

HPV16 genome structure analysis in oropharyngeal cancer ... Here we characterize HPV genome structures in eight HPV16+ OPC patient-derived xenografts (PDXs), and evaluate their responses to standard chemotherapy.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7787351/

Methylation of HPV 16 and EPB41L3 in oral gargles Methylation of the HPV 16 L1, L2 and E2 regions and the host EPB41L3 gene have been validated as biomarkers for the detection of high-grade cervical ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772906024005569

Molecular mechanisms and diagnostic innovations in HPV ... The International Agency for Research on Cancer (IARC) has classified HPV type 16 as a definitive carcinogen for the oral cavity and oropharynx. HPV-related ...