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Search / Trial NCT06305676

Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · Mar 6, 2024

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Oropharyngeal Cancer Early Detection Screening

ClinConnect Summary

The BASH OPC trial is studying a new way to detect a specific type of throat cancer that is linked to the human papillomavirus (HPV). Researchers are testing a special test that looks for HPV DNA and changes in certain genes to see if it can accurately identify early cases of oropharyngeal cancer (OPC) before any treatment is given. They will compare results from 100 patients with early-stage cancer, 100 with late-stage cancer, and 200 healthy individuals who are similar in age, sex, race, and tobacco use, all collected from two major cancer centers.

To participate in this trial, you need to be at least 18 years old and have a newly diagnosed, confirmed case of squamous cell carcinoma of the oropharynx that hasn't been treated yet. You should also not have any history of head and neck cancers or HPV-related cancers. If you join the study, you'll provide consent to participate and help researchers learn more about this cancer detection method. This trial is currently recruiting participants and aims to improve early detection, which is important for better treatment outcomes.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • Not meeting all of the above inclusion criteria for either the case or control group

About H. Lee Moffitt Cancer Center And Research Institute

H. Lee Moffitt Cancer Center and Research Institute is a leading institution dedicated to cancer research, treatment, and education, recognized for its commitment to advancing cancer care through innovative clinical trials and groundbreaking research. As a National Cancer Institute-designated Comprehensive Cancer Center, Moffitt integrates cutting-edge science with patient-centered care, offering a multidisciplinary approach to cancer treatment. The center is at the forefront of developing novel therapies and improving outcomes for patients, emphasizing collaboration between researchers and clinicians to translate scientific discoveries into effective treatments. Through its extensive clinical trial programs, Moffitt aims to enhance the understanding of cancer biology and provide patients with access to the latest therapies and interventions.

Locations

Tampa, Florida, United States

Pittsburgh, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Anna Giuliano, PhD

Principal Investigator

Moffitt Cancer Center

Antonio Amelio, PhD

Principal Investigator

Moffitt Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported