NCT05093400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 17, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

September 17, 2021

Last Update Submit

July 5, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Oncologic strains in HPV DNA salivary samples

    Number of patients to have oncologic strains of HPV DNA in salivary samples

    2 years

Study Arms (1)

Normal Saliva

saliva from "normal healthy" adults.

Other: no intervention

Interventions

no interventionOTHER

saliva collection

Normal Saliva

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy non-cancerous participants

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva, and tumor tissue

Study Officials

  • Kathryn Van Abel, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2021

First Posted

October 26, 2021

Study Start

September 17, 2021

Primary Completion

May 2, 2023

Study Completion

May 5, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Locations

US(1)