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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03921658
Other study ID # 2019NTLS030
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 22, 2019
Est. completion date April 2, 2024

Study information

Verified date April 2024
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 255
Est. completion date April 2, 2024
Est. primary completion date April 2, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (2)

Lead Sponsor Collaborator
University of Minnesota United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. post treatment
Primary Cohort 2 - Recurrence-free survival Time from diagnosis to first known recurrence or death, censored at least follow-up if recurrence free and alive 3 years
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