1,500 volunteers tracked to uncover hidden throat cancer clues
NCT ID NCT03644563
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study is screening 1,500 adults for oral HPV infection and antibodies to build a group at higher risk for HPV-related throat cancer. Researchers will follow them over time to see which infections persist and what factors (like mouth bacteria or immune response) increase cancer risk. No treatment is given—the goal is to learn how to predict and possibly prevent this cancer in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help identify who is at highest risk for HPV-related throat cancer, leading to better screening or prevention strategies.
- What could go wrong
- This is an observational study, not a treatment trial. It may not lead to any direct medical benefit, and results may take years to translate into practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2017
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Target sample size: 1325 (phase 1), \~250 (phase 2) Inclusion of women and minorities: Primary enrollment is restricted to men, given their higher risk of infection (see eligibility criteria). However, the investigators expect to enroll women with cervical dysplasia and partners of patients with HPV-related cancer (\~125 expected women enrollees). Enrollment is across many different sources (geographically, and by clinic type), and is inclusive of diverse racial and ethnic backgrounds. Enrollment is not stratified by race but the investigators expect to enroll at least 175 minorities in the study.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Participants in the Phase 1 Screening Inclusion criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * 18 and older (enrollment at most sites will be restricted to 30 and older since this demographic has the highest prevalence of infection; however, individuals and/or partners of someone with an HPV-related cancer, for example, are at increased risk so will be enrolled in the larger age range). * Willing to be contacted to arrange follow-up visits, if determined to be eligible for phase 2 * Ability to understand and the willingness to sign a written informed consent document In addition, individuals must meet at least one of the following criteria: * Male, aged 30 and older, with 2 or more lifetime oral sex * History of anal or genital dysplasia or cancer * Partners of someone with an HPV-related cancer (HPV-positive OPC, anal cancer or genital cancer) * Known oncogenic HPV-positive biomarker from prior studies or testing, regardless of number of partners. Exclusion criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent. * Participants who do not speak English cannot enroll because the consent and study survey are only available in English. However, if there is a hearing, literacy or minor fluency issue and the participant requests assistance from a family member or the study coordinator, this individual may still enroll and receive this assistance to ensure they fully hear and understand everything being asked. * History of head and neck cancer Participants in the Phase 2 Follow-Up Inclusion criteria: * Oncogenic oral HPV infection and/or HPV serum oncogenic antibodies detected in phase 1 * Willingness to complete annual follow up visits Exclusion criteria: • Unable to complete annual follow up visits
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, 21205, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a simple Self-Swab revolutionize cervical cancer screening?
- Can the HPV vaccine fully protect transgender women and people with HIV?