Oropharyngeal Squamous Cell CarcinomaNCT06362421
Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer
An observational study of Oropharyngeal Squamous Cell Carcinoma and Human Papillomavirus Infection, run by Wake Forest University Health Sciences.
Trial summary
The purpose of this research study is to determine if saliva and oral swab samples can be used to detect human papillomavirus in patients with cancer. In this study, the methods required to detect human papillomavirus will be developed and tested in samples collected from patients with oropharyngeal squamous cell… Read more about this study
- Who is it for?
- Ages 39 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma, Human Papillomavirus Infection
- What is being tested?
- Pre-Radiation Dental Evaluation/Sample Collection, Pre-Study Visit and Oral Medicine Consultation Visit/Sample Collection
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Aug 2026
- Phase
- Observational
- 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 39 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The Head and Neck oncology team and navigators, as well as tumor board meetings, will be leveraged to identify and recruit newly diagnosed patients. Participants in the healthy control group will be identified and recruited and enrolled after patients in the research cohort (those with OPSCC) participants have been enrolled.
Who may be able to join
- Patients must have histologically confirmed oropharyngeal squamous cell carcinoma without prior treatment. A pathology report should be referenced/available.
- Patients with p16 positive oropharyngeal squamous cell carcinoma.
- Age 39 to 59 years.
- Ability to understand and the willingness to sign an IRB-approved informed consent document directly.
- Age 39 to 59 years.
- Ability to understand and the willingness to sign an IRB-approved informed consent document directly.
Who cannot join
- Patients with diagnoses of other cancers.
- Patients with current or previous diagnosis with HPV+ infection status for cervical cancer or other cancers.
- Previous diagnosis of cervical cancer or other cancers.
- Presence of known active oral infections of viral, fungal, or bacterial etiology except for gingivitis, periodontitis, or periapical abscess. Participants with known gingivitis, periodontitis, or periapical abscess are included.
About this study
Official title: Proof of Concept Assay Development of Point of Care Saliva Testing for High Risk-HPV Oral Cavity and Pharynx Cancers
The purpose of this research study is to determine if saliva and oral swab samples can be used to detect human papillomavirus in patients with cancer. In this study, the methods required to detect human papillomavirus will be developed and tested in samples collected from patients with oropharyngeal squamous cell carcinoma and compared to samples collected from participants without cancer.
Read the detailed description
To validate the detection of human papillomavirus 16 and 18 and reference gene ACTB in saliva and buccal swab samples obtained from patients with oropharyngeal squamous cell carcinoma (OPSCC) using the LAMP/CRISPR/electrochemical workflow.
- Being tested
- Pre-Radiation Dental Evaluation/Sample Collection, Pre-Study Visit, Oral Medicine Consultation Visit/Sample Collection
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Radiation Dental Evaluation/Sample CollectionGenetic
Collection of saliva samples and mouth swabs and pre-cancer dental evaluation by study staff. Unstimulated saliva will be collected then a buccal swab sample will be obtained. Participants will be asked to rinse their mouth with water, wait 10 minutes, then 1-2 mL of unstimulated saliva will be captured into sterile centrifuge tube. Next, a buccal swab sample will be collected using a sterile cotton swab and immediately placed in a transport tube containing buffer (Tris with low EDTA)
Pre-Study VisitOther
Collection of vital signs, medical history and current medications
Oral Medicine Consultation Visit/Sample CollectionGenetic
Collection of saliva samples and mouth swab, complete oral medicine consultation by study staff. Unstimulated saliva will be collected then a buccal swab sample will be obtained. Participants will be asked to rinse their mouth with water, wait 10 minutes, then 1-2 mL of unstimulated saliva will be captured into sterile centrifuge tube. Next, a buccal swab sample will be collected using a sterile cotton swab and immediately placed in a transport tube containing buffer (Tris with low EDTA)
| Study group | Role | What they receive |
|---|---|---|
| Treatment naive patients with HPV+ OPSCC | Participants will receive a pre-study visit and pre-radiation dental evaluation. Receives: Genetic: Pre-Radiation Dental Evaluation/Sample Collection; Other: Pre-Study Visit | |
| Control Group - Healthy subjects without cancer | Participants will receive a pre-study visit and oral medicine consultation visit. Receives: Other: Pre-Study Visit; Genetic: Oral Medicine Consultation Visit/Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Sensitivity for Detection of HPV 16, 18 and gene ACTB
The sensitivity of the LAMP/CRISPR/electrochemical workflow for detection of HPV 16, 18, and reference gene ACTB will be measured using patient samples with a 95% Clopper Pearson Exact Binomial confidence interval for the estimated sensitivity (or specificity) will have a lower bound of 83% if the observed sensitivity (or specificity) is 95%. For each of these estimates investigators will examine the proportion and the corresponding 95% Clopper Pearson exact binomial confidence interval.
Measured: Up to 2 years
Number of Participants with Specificity Detection of HPV 16, 18 and gene ACTB
The specificity of the LAMP/CRISPR/electrochemical workflow for detection of HPV 16, 18, and reference gene ACTB will be measured using patient samples with a 95% Clopper Pearson Exact Binomial confidence interval for the estimated sensitivity (or specificity) will have a lower bound of 83% if the observed sensitivity (or specificity) is 95%. For each of these estimates investigators will examine the proportion and the corresponding 95% Clopper Pearson exact binomial confidence interval.
Measured: Up to 2 years
Overall Accuracy - All Participants
For estimating overall accuracy (using all patients with n=80), the confidence interval will have a lower bound of 88% if the accuracy is at least 95%. For each of these estimates investigators will examine the proportion and the corresponding 95% Clopper Pearson exact binomial confidence interval.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Why it stopped: PI not moving forward with study at our institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- InnoTech Precision Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362421
- Sponsor's protocol ID
- IRB00115786
- Other IDs
- ONC-HN-2402
- Status last verified
- Jul 2025
- First submitted
- 8 Apr 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Assay Development of Point of Care Saliva Testing for High Risk-HPV Oral Cavity and Pharynx Cancers
- ClinicalTrials.gov ID
- NCT06362421
- Acronym / sponsor ID
- IRB00115786
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI not moving forward with study at our institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- InnoTech Precision Medicine
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 12 Apr 2024 (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.
The purpose of this research study is to determine if saliva and oral swab samples can be used to detect human papillomavirus in patients with cancer. In this study, the methods required to detect human papillomavirus will be developed and tested in samples collected from patients with oropharyngeal squamous cell carcinoma and compared to samples collected from participants without cancer.
Detailed description
To validate the detection of human papillomavirus 16 and 18 and reference gene ACTB in saliva and buccal swab samples obtained from patients with oropharyngeal squamous cell carcinoma (OPSCC) using the LAMP/CRISPR/electrochemical workflow.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment naive patients with HPV+ OPSCC | – | Genetic: Pre-Radiation Dental Evaluation/Sample Collection, Other: Pre-Study VisitParticipants will receive a pre-study visit and pre-radiation dental evaluation. |
| Control Group - Healthy subjects without cancer | – | Other: Pre-Study Visit, Genetic: Oral Medicine Consultation Visit/Sample CollectionParticipants will receive a pre-study visit and oral medicine consultation visit. |
Who may qualify
- Ages
- 39 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The Head and Neck oncology team and navigators, as well as tumor board meetings, will be leveraged to identify and recruit newly diagnosed patients. Participants in the healthy control group will be identified and recruited and enrolled after patients in the research cohort (those with OPSCC) participants have been enrolled.
Key inclusion criteria (6 listed)
- Patients must have histologically confirmed oropharyngeal squamous cell carcinoma without prior treatment. A pathology report should be referenced/available.
- Patients with p16 positive oropharyngeal squamous cell carcinoma.
- Age 39 to 59 years.
- Ability to understand and the willingness to sign an IRB-approved informed consent document directly.
- Age 39 to 59 years.
Key exclusion criteria (4 listed)
- Patients with diagnoses of other cancers.
- Patients with current or previous diagnosis with HPV+ infection status for cervical cancer or other cancers.
- Previous diagnosis of cervical cancer or other cancers.
- Presence of known active oral infections of viral, fungal, or bacterial etiology except for gingivitis, periodontitis, or periapical abscess. Participants with known gingivitis, periodontitis, or periapical abscess are included.
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 |
|---|---|---|
| Pre-Radiation Dental Evaluation/Sample CollectionCollection of saliva samples and mouth swabs and pre-cancer dental evaluation by study staff. Unstimulated saliva will be collected then a buccal swab sample will be obtained. Participants will be asked to rinse their mouth with water, wait 10 minutes, then 1-2 mL of unstimulated saliva will be captured into sterile centrifuge tube. Next, a buccal swab sample will be collected using a sterile cotton swab and immediately placed in a transport tube containing buffer (Tris with low EDTA) | Genetic | Treatment naive patients with HPV+ OPSCC |
| Pre-Study VisitCollection of vital signs, medical history and current medications | Other | Control Group - Healthy subjects without cancer, Treatment naive patients with HPV+ OPSCC |
| Oral Medicine Consultation Visit/Sample CollectionCollection of saliva samples and mouth swab, complete oral medicine consultation by study staff. Unstimulated saliva will be collected then a buccal swab sample will be obtained. Participants will be asked to rinse their mouth with water, wait 10 minutes, then 1-2 mL of unstimulated saliva will be captured into sterile centrifuge tube. Next, a buccal swab sample will be collected using a sterile cotton swab and immediately placed in a transport tube containing buffer (Tris with low EDTA) | Genetic | Control Group - Healthy subjects without cancer |
Primary outcome
Number of Participants with Sensitivity for Detection of HPV 16, 18 and gene ACTB
Time frame: Up to 2 years
The sensitivity of the LAMP/CRISPR/electrochemical workflow for detection of HPV 16, 18, and reference gene ACTB will be measured using patient samples with a 95% Clopper Pearson Exact Binomial confidence interval for the estimated sensitivity (or specificity) will have a lower bound of 83% if the observed sensitivity (or specificity) is 95%. For each of these estimates investigators will examine the proportion and the corresponding 95% Clopper Pearson exact binomial confidence interval.
Number of Participants with Specificity Detection of HPV 16, 18 and gene ACTB
Time frame: Up to 2 years
The specificity of the LAMP/CRISPR/electrochemical workflow for detection of HPV 16, 18, and reference gene ACTB will be measured using patient samples with a 95% Clopper Pearson Exact Binomial confidence interval for the estimated sensitivity (or specificity) will have a lower bound of 83% if the observed sensitivity (or specificity) is 95%. For each of these estimates investigators will examine the proportion and the corresponding 95% Clopper Pearson exact binomial confidence interval.
Overall Accuracy - All Participants
Time frame: Up to 2 years
For estimating overall accuracy (using all patients with n=80), the confidence interval will have a lower bound of 88% if the accuracy is at least 95%. For each of these estimates investigators will examine the proportion and the corresponding 95% Clopper Pearson exact binomial confidence interval.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Squamous Cell Carcinoma and Human Papillomavirus Infection, run by Wake Forest University Health Sciences.
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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of Participants with Sensitivity for Detection of HPV 16, 18 and gene ACTB (time frame: Up to 2 years). The study lists 3 primary outcomes in all. 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 31 Jul 2025.