RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-01-22
Study Completion:2029-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06305676

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged at least 18 years
  2. * Newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages I-IV)
  3. * Has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks
  4. * 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
  5. * Aged at least 35 years
  6. * Have no previous diagnosis of HNC or HPV-related cancer
  7. * Fully understands study procedures
  8. * 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
  1. * Not meeting all of the above inclusion criteria for either the case or control group

Contacts and Locations

Study Contact

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

Principal Investigator

Anna Giuliano, PhD
PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Antonio Amelio, PhD
PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center
Tampa, Florida, 33612
United States
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

  • Anna Giuliano, PhD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center
  • Antonio Amelio, PhD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-22
Study Completion Date2029-01

Study Record Updates

Study Start Date2024-01-22
Study Completion Date2029-01

Terms related to this study

Keywords Provided by Researchers

  • Oropharyngeal Cancer
  • Early Detection
  • Screening

Additional Relevant MeSH Terms

  • Oropharyngeal Cancer
  • HPV-Related Carcinoma