Oropharynx (OPX) Salivary Biomarker Study

NCT ID: NCT05093400

Last Updated: 2023-07-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-17

Study Completion Date

2023-05-05

Brief Summary

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The goal of this study is to analyze certain biomarkers to look at the relationship between HPV in the saliva, stage at presentation, and a potential self-test compared to saliva of non-cancerous participants.

Detailed Description

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Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal Saliva

saliva from "normal healthy" adults.

no intervention

Intervention Type OTHER

saliva collection

Interventions

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no intervention

saliva collection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Oropharynx or Oral Cavity Squamous Cell Carcinoma Patients: collected under the OPX Biomarker Protocol (IRB: 19-006036).

Normal Controls:

* Age ≥ 18 years;
* Able to provide informed written consent documenting permission to give saliva sample for research testing.;
* Ability to complete questionnaire(s) by themselves or with assistance.

Exclusion Criteria

* Oropharynx or Oral Cavity Squamous Cell Carcinoma Patients: collected under the OPX Biomarker Protocol (IRB: 19-006036).

Normal Controls:

* Any personal history of head or neck cancer including head or neck skin cancer.
* Other active malignancy ≤ 5 years prior to registration.
* EXCEPTIONS: Non-melanotic skin cancer, non-metastatic prostate cancer.
* NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.
* Dry mouth (xerostomia) caused by any chronic (\>30 days) condition (known or unknown) or medication.
* Recent (within 30 days) or active upper aerodigestive tract or anogenital infections.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Kathryn (Katie) M. Van Abel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathryn Van Abel, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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21-006529

Identifier Type: -

Identifier Source: org_study_id

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