The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer

University of Minnesota (UMN)

Status: Completed

Conditions: Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Ovarian Cancer

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03921658

2019NTLS030

Details and patient eligibility

About

Cytomegalovirus (CMV), a widely prevalent virus in the general US population, has been shown to be associated with increased inflammation and mortality. Previous small pilot studies have demonstrated that latent CMV may be reactivated during chemotherapy in cancer patients, and may be associated with unfavorable cancer outcomes such as fatigue and increased mortality.

The central research idea for this study, supported by previous preliminary data, is that CMV reactivation is an unrecognized complicating factor in the treatment of ovarian cancer that impacts patient outcomes. The overarching goals of this observational study are:

• To assess how CMV infection is associated with ovarian cancer symptoms over the course of the disease and its treatment.
• To describe the relationship between CMV reactivation in ovarian cancer patients, survival, fatigue, and other QOL outcomes, both cross-sectionally and longitudinally.

Enrollment: 255 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18
• Ability to read and write in English
• women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer
• Treatment plan includes chemotherapy
• Able to provide written voluntary consent before performance of any study related procedure.
• Cohort 1 only: within 2 years of completing initial chemotherapy treatment
• Cohort 2 only: prior to starting chemotherapy

Exclusion criteria

• Inability to provide informed written consent
• Previous exposure to chemotherapy
• Life expectancy < 3 months or in hospice care or nursing home

Trial design

255 participants in 2 patient groups

Cohort 1 - Cross-sectional (within 2 years of diagnosis)

Description:

Individuals diagnosed and treated for ovarian cancer in past two years, will complete 1 study measure

Cohort 2- Prospective (from diagnosis)

Description:

Individuals newly diagnosed with ovarian cancer, will complete 3 study measures (baseline/diagnosis, completion of chemotherapy, one year post-diagnosis)