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NCT03921658Completed

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

Source: ClinicalTrials.gov · Last updated 10 Apr 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
255 (actual)
First submitted
16 Apr 2019
Start date
22 Oct 2019
Primary completion date
2 Apr 2024
Lead sponsor
University of Minnesota
NCT number
NCT03921658

What you commit to

  • Study type: Observational
  • Participants enrolled: 255
  • From 22 Oct 2019 to the primary completion date, 2 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous exposure to chemotherapy

Other

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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Minnesota
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.