- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06356272
Oropharynx (OPX) Biomarker Trial
Study Overview
Status
Conditions
- Oropharyngeal Squamous Cell Carcinoma
- Recurrent Oropharyngeal Squamous Cell Carcinoma
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Metastatic Oropharyngeal Squamous Cell Carcinoma
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To identify a biomarker (or biomarkers) that is present when disease is present (i.e., at diagnosis or recurrence) and not present when disease is absent (i.e., after treatment, in HPV negative patients or in normal controls).
OUTLINE: This is an observational study.
Patients undergo blood sample collection, saliva sample collection, complete questionnaires and have their medical records reviewed on study.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
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Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
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Principal Investigator:
- Kathryn M. Van Abel, M.D.
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Contact:
- Diane Vogen
- Phone Number: 507-266-1247
- Email: Vogen.Diane2@mayo.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
* Age ≥ 18 years
- Able to provide written consent
- All patients must undergo p16 staining on biopsy for enrollment
- All patients must undergo HPV16 family ISH and/or RNA on biopsy or surgical specimen, unless amount of tissue is too small to have conclusive HPV ISH testing done on it
- Patients with < 70% of tumor cells positive for p16 will be considered p16 negative
- Patient has given permission to give his/her tumor/tissue/blood/saliva sample for research testing
- Clinical diagnosis of oropharyngeal squamous cell carcinoma or clinical diagnosis of HPV negative oral cavity cancer, to be enrolled for subgroup 1D
- Ability to complete questionnaire(s) by themselves or with assistance
- Willingness and intent to return in person to enrolling institution for follow-up (during the Active Monitoring Phase of the study) for at least 2 of the standard follow-up time points for a total of 3 time-points including pre-treatment. A participant who does not return in person to Mayo Clinic Rochester for every standard of care post-treatment follow up will not be considered deviating from the protocol
Exclusion Criteria:
* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Patients enrolled in DART are eligible
- History of any head and neck malignancy, other than HPV+ oropharyngeal squamous cell carcinoma
Other active malignancy ≤ 5 years prior to registration
- EXCEPTIONS: Non-melanotic skin cancer, non-metastatic thyroid cancer, non-metastatic prostate cancer, carcinoma-in-situ of the cervix, HPV+ oropharyngeal SCC (which can be enrolled in group 3)
- NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational
Patients undergo blood sample collection, saliva sample collection, complete questionnaires and have their medical records reviewed on study.
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Non-interventional study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in biomarkers
Time Frame: Up to 24 months
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Biospecimen samples will be assessed for a biomarker (or biomarkers) that is present when disease is present (i.e., at diagnosis or recurrence) and not present when disease is absent (i.e., after treatment, in HPV negative patients or in normal controls).
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Up to 24 months
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Oncologic outcomes associated with biomarkers
Time Frame: Up to study completionUp to 24 months
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Survival outcome (overall survival, disease-free survival, and distant failure) will be compared with blood, tissue and saliva biomarkers identified throughout the treatment course.
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Up to study completionUp to 24 months
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Genetic alterations
Time Frame: Up to 24 months
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Alterations in oropharynx tumor specimens will be compared with the detection rate of corresponding circulating DNA in oropharynx cancer patients throughout their treatment course
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Up to 24 months
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Immunologic biomarkers for predicting progression free survival
Time Frame: Up to 24 months
|
Detected immunologic biomarkers will be compared with overall survival to determine whether biomarkers can be used to predict likelihood of progression free survival.
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Up to 24 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kathryn M. Van Abel, M.D., Mayo Clinic in Rochester
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Oropharyngeal Neoplasms
Other Study ID Numbers
- 19-006036 (Other Identifier: Mayo Clinic Institutional Review Board)
- NCI-2024-00965 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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