The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT03921658|
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : July 11, 2019
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.
|Condition or disease|
|Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma|
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|Official Title:||The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||May 31, 2022|
|Estimated Study Completion Date :||May 31, 2023|
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)
- Cohort 1 - Cancer-related fatigue [ Time Frame: post treatment ]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.
- Cohort 2 - Recurrence-free survival [ Time Frame: 3 years ]Time from diagnosis to first known recurrence or death, censored at least follow-up if recurrence free and alive
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921658
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Rachel I Vogel, PhD 612-624-6928 firstname.lastname@example.org|
|Principal Investigator: Rachel I Vogel, PhD|