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Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer
Study Purpose
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.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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Inclusion Criteria (Patients with Cancer);
- - Patients must have histologically confirmed oropharyngeal squamous cell carcinoma
without prior treatment.
A pathology report should be referenced/available.- - Ability to understand and the willingness to sign an IRB-approved informed consent
document directly.
Inclusion Criteria (Healthy Subjects)- - Ability to understand and the willingness to sign an IRB-approved informed consent
document directly.
Exclusion Criteria (Patients with Cancer)- - Patients with current or previous diagnosis with HPV+ infection status for cervical
cancer or other cancers.
Exclusion Criteria (Healthy Subjects)- - 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.Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
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Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
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The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Arms
: Treatment naive patients with HPV+ OPSCC
Participants will receive a pre-study visit and pre-radiation dental evaluation.
: Control Group - Healthy subjects without cancer
Participants will receive a pre-study visit and oral medicine consultation visit.
Interventions
Genetic: - Pre-Radiation Dental Evaluation/Sample Collection
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)
Other: - Pre-Study Visit
Collection of vital signs, medical history and current medications
Genetic: - Oral Medicine Consultation Visit/Sample Collection
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)
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Hayworth Cancer Center
High Point, North Carolina, 27262
Site Contact
Study Coordinator
[email protected]
336-713-1790
Status
Address
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Site Contact
Study Coordinator
[email protected]
336-713-1790
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