Oropharynx (OPX) Salivary Biomarker Study | NCT05093400

Studies
Oropharynx (OPX) Salivary Biomarker Study

NCT05093400

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jul 7, 2023Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Healthy

Interventions

no intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 17, 2021Actual

Primary Completion Date

May 2, 2023Actual

Completion Date

May 5, 2023Actual

First Submitted Date

Sep 17, 2021

First Submission Date that Met QC Criteria

Oct 25, 2021

First Posted Date

Oct 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2023

Last Update Posted Date

Jul 7, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal Saliva		saliva from "normal healthy" adults.	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	saliva collection	Normal Saliva

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oncologic strains in HPV DNA salivary samples	Number of patients to have oncologic strains of HPV DNA in salivary samples	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy non-cancerous participants

Sampling Method

Probability Sample