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

NCT06870539 | Completed

• 3 other identifiers: 24-011332NCI-2025-01230P50CA136393
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the feasibility and accuracy of using saliva to remotely monitor cytomegalovirus (CMV) infection in individuals receiving treatment for ovarian cancer.

Conditions

Cytomegaloviral Infection; Ovarian Carcinoma; Primary Peritoneal Carcinoma; Cancer-related Cognitive Dysfunction; Fallopian Tube Carcinoma

Outcome Measures

Primary Outcomes (1)

• Using saliva and blood samples to remotely monitor cytomegalovirus (CMV) infection

  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

Study Arms (1)

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

Interventions

Non-Interventional Study OTHER

Non-Interventional Study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ovarian cancer undergoing active treatment at the Mayo Clinic

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials
• University of Minnesota Medical School Clinical Trials \& Studies

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples retained for future research only with permission of participant

MeSH Terms

Conditions

Cytomegalovirus Infections; Fallopian Tube Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Amanika Kumar, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 11, 2025
• Study Start: March 7, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-09

Locations

US (2)