Sponsor study identifier
observational
255
1 country
1
Study Start
October 22, 2019
Actual (reported)Primary Completion
April 2, 2024
Actual (reported)Study Completion
April 2, 2024
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 16, 2019
Actual (reported)April 19, 2019
Actual (reported)October 22, 2019
Actual (reported)April 2, 2024
Actual (reported)April 2, 2024
Actual (reported)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
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
Individuals diagnosed and treated for ovarian cancer in past two years, will complete 1 study measure
Individuals newly diagnosed with ovarian cancer, will complete 3 study measures (baseline/diagnosis, completion of chemotherapy, one year post-diagnosis)
Individuals diagnosed and/or treated for ovarian/Fallopian tube/primary peritoneal cancer by physicians in the Gynecologic Oncology Clinic at the University of Minnesota
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Blood samples at up to 3 time points
255 participants (actual enrollment reported by the registry).
First Submitted
April 16, 2019
First Posted
April 19, 2019
Study Start
October 22, 2019
Actual (reported)A Phase 1b Study of Paclitaxel And Ricolinostat For The Treatment Of Gynecological Cancer
Contact the study team to confirm eligibility.
Primary Completion
April 2, 2024
Actual (reported)Study Completion
April 2, 2024
Actual (reported)Last Updated
April 10, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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