Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
440 participants
OBSERVATIONAL
2019-11-15
2029-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational
Patients undergo blood sample collection, saliva sample collection, complete questionnaires and have their medical records reviewed on study.
Non-Interventional Study
Non-interventional study
Interventions
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Non-Interventional Study
Non-interventional study
Eligibility Criteria
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Inclusion Criteria
* Able to provide written consent
* Groups 1-3:
* Must undergo p16 staining on biopsy for enrollment
* Patients with \< 70% of tumor cells positive for p16 will be considered p16 negative
* Must undergo HPV16 family in situ hybridization (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
* 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
* Group 4:
* Clinical suspicion or histopathologic diagnosis of head and neck cancer or neoplasm
* Primary salivary neoplasm
* Primary thyroid neoplasm
* Primary head and neck neoplasm
* Multi-cancer early detection (MCED) testing concerning for cancer
* Patient has given permission to give his/her tumor/tissue/blood/saliva sample for research testing
* Ability to complete questionnaire(s) by themselves or with assistance
Exclusion Criteria
* Groups 1-3:
* 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 squamous cell carcinoma (SCC) (which can be enrolled in group 3)
* NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
* History of any head and neck malignancy, other than the tumor for which they are being treated
* Group 4, Cohort A, B, C:
* Other active malignancy ≤ 5 years prior to registration
* EXCEPTIONS: Non-metastatic prostate cancer, carcinoma-in-situ of the cervix, non metastatic cutaneous basal cell carcinoma
* NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
* History of any head and neck malignancy, other than the present neoplasm
* Note these are clarifications of inclusion into Group 4, Cohorts D and E:
* Presence of other active malignancy or recurrent head and neck neoplasms are allowed in this arm
* Receipt of cancer specific therapy for other malignancy is allowed in this arm
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Kathryn M. Van Abel, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2024-00965
Identifier Type: REGISTRY
Identifier Source: secondary_id
19-006036
Identifier Type: OTHER
Identifier Source: secondary_id
19-006036
Identifier Type: -
Identifier Source: org_study_id
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