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CompletedNCT03921658Updated Apr 10, 2024

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

An observational study in Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Carcinoma, sponsored by University of Minnesota. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-10.

Sponsored by University of Minnesota · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
255
Ages
18 Years and older
Sex
Female
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Study summary

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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Conditions studied

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Carcinoma
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 255 is above the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals diagnosed and/or treated for ovarian/Fallopian tube/primary peritoneal cancer by physicians in the Gynecologic Oncology Clinic at the University of Minnesota

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
255 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • 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)

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What researchers measure

Primary outcomes

  1. Cohort 1 - Cancer-related fatigue

    Cancer-related fatigue will be measured using the Fatigue Symptom Inventory. The scale is composed of 14 items (one is not scored). A total Disruption Index is calculated by summing items 5-11 (each item ranges from 0-10). A lower score indicates lower fatigue. Possible range is 0-70.

    Time frame: post treatment

  2. Cohort 2 - Recurrence-free survival

    Time from diagnosis to first known recurrence or death, censored at least follow-up if recurrence free and alive

    Time frame: 3 years

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Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03921658
Lead sponsor
University of Minnesota
Collaborators
United States Department of Defense
Responsible party
Sponsor
First posted
Apr 19, 2019
Start date
Oct 22, 2019
Primary completion
Apr 2, 2024
Completion
Apr 2, 2024
Last update
Apr 10, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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