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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-22

Study Completion Date

2024-04-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

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

No interventions assigned to this group

Cohort 2- Prospective (from diagnosis)

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

No interventions assigned to this group

Eligibility Criteria

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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