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The role of cytomegalovirus and inflammation on patient symptoms and outcomes in ovarian cancer

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The central research idea for this award is that CMV reactivation is an unrecognized complicating factor in the treatment of ovarian cancer. Based on preliminary data, our hypotheses are: a) ovarian cancer patients with elevated biomarkers of CMV report greater fatigue and poorer quality of life; b) CMV and inflammation (C-reactive protein; CRP) levels in ovarian cancer patients are higher post-chemotherapy than baseline; c) ovarian cancer patients who experience increases in CMV and/or CRP report greater fatigue and poorer quality of life; d) ovarian cancer patients who experience increases in CMV and CRP will have shorter recurrence-free and overall survival. We propose the following specific aims and studies to address these research questions: Aim 1: Determine the relationship between CMV and ovarian cancer patient-reported symptoms post-treatment. A cross-sectional study of 200 women with ovarian cancer within two years of completing first line chemotherapy will be recruited for a one-time blood draw and survey. We will assess CMV status by measuring IgG serology and CMV DNA levels in serum (indicative of active infection/reactivation) and determine their relationship with patient-reported symptoms including fatigue and quality of life. Aim 2: Characterize the changes in CMV and CRP levels following chemotherapy and their association with patient symptoms and outcomes. A prospective study of 150 women with newly diagnosed ovarian cancer will evaluate the association between serum CMV IgG, CRP IgG, and CMV DNA levels and patient-reported symptoms, recurrence-free and overall survival. Planned blood samples include before, after and 6 months post-chemotherapy completion with planned surveys and clinical follow-up at least every six months for five years.

I'm interested

Female
18 Years and over
This study is NOT accepting healthy volunteers
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

Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Clinics and Surgery Center (CSC)

Aaron Grad - gradx005@umn.edu
Rachel Vogel
NA
STUDY00005451
NCT03921658
See this study on ClinicalTrials.gov

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