NCT06305676

Brief Summary

Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Jan 2024Jan 2029

Study Start

First participant enrolled

January 22, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

4.9 years

First QC Date

March 6, 2024

Last Update Submit

February 5, 2026

Conditions

Oropharyngeal CancerHPV-Related Carcinoma

Keywords

Oropharyngeal CancerEarly DetectionScreening

Outcome Measures

Primary Outcomes (2)

  • Diagnostic Sensitivity

    A 95% one-sided confidence interval using the Wilson method will be obtained for sensitivity for the early Oropharyngeal Cancer cases and late Oropharyngeal Cancer cases.

    Up to 60 months

  • Diagnostic Specificity

    A 95% one-sided confidence interval using the Wilson method will be obtained for Specificity based on the control patients.

    Up to 60 months

Study Arms (2)

Case Group

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

Diagnostic Test: combined HPV 16 DNA and host gene methylation oral biomarker panel

Control Group

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.

Diagnostic Test: combined HPV 16 DNA and host gene methylation oral biomarker panel

Interventions

combined HPV 16 DNA and host gene methylation oral biomarker panelDIAGNOSTIC_TEST

DNA Methylation Profiling

Case GroupControl Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of 100 early and 100 late disease pre-treatment Oropharyngeal Cancer cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).

You may qualify if:

  • Cases:
  • Aged at least 18 years
  • Newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages I-IV)
  • Has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks
  • Provided written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is identified and enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center
  • Aged at least 35 years
  • Have no previous diagnosis of HNC or HPV-related cancer
  • Fully understands study procedures
  • Voluntarily agrees to participate by giving written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Anna Giuliano, PhD

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

  • Antonio Amelio, PhD

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Isaacs-Soriano

CONTACT

813-745-6992kimberly.Isaacs-Soriano@moffitt.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2024

First Posted

March 12, 2024

Study Start

January 22, 2024

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

US(2)