Feasibility of Saliva and Remote Monitoring of Active Cytomegalovirus (CMV) Infection and Symptoms During Ovarian Cancer Treatment

December 2, 2025 updated by: Mayo Clinic
This study evaluates the feasibility and accuracy of using saliva to remotely monitor cytomegalovirus (CMV) infection in individuals receiving treatment for ovarian cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota/Masonic Cancer Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with ovarian cancer undergoing active treatment at the Mayo Clinic

Description

Inclusion Criteria:

  • Age ≥ 18
  • Ability to read and write in English
  • Diagnosed with ovarian cancer (ovarian, primary peritoneal, fallopian tube)
  • Receiving care from providers at Mayo Clinic
  • Regardless of diseases status, actively receiving treatment for ovarian cancer (frontline, maintenance, progression, recurrence)

Exclusion Criteria:

  • Pregnant at the time of study participation
  • Inability to provide informed written consent
  • History of dementia, stroke, brain tumors or other condition which may impair cognitive functioning

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients undergo saliva sample collection as well as in-clinic or at-home blood sample collection on study. Patients also complete questionnaires, undergo cognitive function testing, and have their medical records reviewed on study.
Other: Non-Interventional Study
Non-Interventional Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Using saliva and blood samples to remotely monitor cytomegalovirus (CMV) infection
Time Frame: Baseline
Assessed through collection and comparison of blood and saliva samples collected from individuals receiving treatment for ovarian cancer. Samples may be collected in clinic or at home following study enrollment. Saliva will be self-collected using Oragene OGR-600 kits. Blood samples will be collected at the time of another scheduled clinic blood draw (Aim 1) or at home through a home phlebotomy service (Aim 2).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Amanika Kumar, MD, Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2025

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-011332 (Other Identifier: Mayo Clinic Institutional Review Board)
  • P50CA136393 (U.S. NIH Grant/Contract)
  • NCI-2025-01230 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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