HPV Positive Oropharyngeal Squamous Cell CarcinomaIDEA-HPVNCT04871490
Improving Detection and Early Action for HPV-positive Oropharynx Cancer
A study testing Blood test for HPV DNA in people with HPV Positive Oropharyngeal Squamous Cell Carcinoma, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study aims to determine whether a blood test for HPV DNA can improve diagnosis of HPV-positive oropharynx cancer (HPV-OPC). Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- HPV Positive Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Blood test for HPV DNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neck mass present for >2 weeks with no signs/symptoms of infection
- Neck mass present for >2 weeks with signs/symptoms of infection that did not resolve with antibiotic therapy
- Palatine or lingual tonsillar asymmetry on physical exam
- Palatine or lingual tonsillar asymmetry on imaging, including asymmetric FDG uptake in palatine or lingual tonsils on PET-CT scans
- Unexplained throat pain for >2 weeks that did not resolve with antibiotic therapy
Who cannot join
- Known diagnosis of HPV-OPC
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02130
About this study
This study aims to determine whether a blood test for HPV DNA can improve diagnosis of HPV-positive oropharynx cancer (HPV-OPC).
Read the detailed description
The diagnosis of HPV-OPC is often delayed. In this study, individuals with signs or symptoms potentially related to HPV-OPC, such as unexplained throat pain, tonsil or tongue base asymmetry, or a neck mass, will have their blood tested for circulating HPV DNA. A positive test may indicate that their symptoms are caused by HPV-OPC, and their treating physician will be encouraged to complete all the necessary testing to determine whether this is the case.
- Being tested
- Blood test for HPV DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test for HPV DNADiagnostic test
All participants will have blood tested for HPV DNA.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Other | All eligible participants. Receives: Diagnostic Test: Blood test for HPV DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of circulating HPV DNA
Proportion of participants with circulating HPV DNA detected in their blood.
Measured: Test results are returned within 1 week.
Secondary outcomes (3)
Predictive value of circulating HPV DNA
Proportion of participants with positive circulating HPV DNA for whom HPV-OPC is detected
Measured: Long-term follow-up for up to 2 years
HPV-OPC awareness
Awareness of HPV-OPC and other HPV-related malignancies among participants will be assessed by a brief survey
Measured: At the time of study enrollment
Impact on clinical practice
The proportion of participants for whom clinicla management by the treating clinician is affected by results of the blood test will be measured by a survey sent to treating clinicials
Measured: Within 2-3 weeks of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start24 Mar 2021
- Primary completion15 Dec 2022
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV Positive Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleni M. Rettig, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871490
- Sponsor's protocol ID
- 2020P003370
- Acronym
- IDEA-HPV
- Status last verified
- Feb 2025
- First submitted
- 29 Apr 2021
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Detection and Early Action for HPV-positive Oropharynx Cancer
- ClinicalTrials.gov ID
- NCT04871490
- Acronym / sponsor ID
- IDEA-HPV / 2020P003370
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine whether a blood test for HPV DNA can improve diagnosis of HPV-positive oropharynx cancer (HPV-OPC).
Detailed description
The diagnosis of HPV-OPC is often delayed. In this study, individuals with signs or symptoms potentially related to HPV-OPC, such as unexplained throat pain, tonsil or tongue base asymmetry, or a neck mass, will have their blood tested for circulating HPV DNA. A positive test may indicate that their symptoms are caused by HPV-OPC, and their treating physician will be encouraged to complete all the necessary testing to determine whether this is the case.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Other | Diagnostic Test: Blood test for HPV DNAAll eligible participants. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Neck mass present for >2 weeks with no signs/symptoms of infection
- Neck mass present for >2 weeks with signs/symptoms of infection that did not resolve with antibiotic therapy
- Palatine or lingual tonsillar asymmetry on physical exam
- Palatine or lingual tonsillar asymmetry on imaging, including asymmetric FDG uptake in palatine or lingual tonsils on PET-CT scans
- Unexplained throat pain for >2 weeks that did not resolve with antibiotic therapy
Key exclusion criteria (1 listed)
- Known diagnosis of HPV-OPC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood test for HPV DNAAll participants will have blood tested for HPV DNA. | Diagnostic test | Study Group |
Primary outcome
Prevalence of circulating HPV DNA
Time frame: Test results are returned within 1 week.
Proportion of participants with circulating HPV DNA detected in their blood.
3 secondary outcomes
Predictive value of circulating HPV DNA
Time frame: Long-term follow-up for up to 2 years
HPV-OPC awareness
Time frame: At the time of study enrollment
Impact on clinical practice
Time frame: Within 2-3 weeks of study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test for HPV DNA in people with HPV Positive Oropharyngeal Squamous Cell Carcinoma, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of circulating HPV DNA (time frame: Test results are returned within 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.