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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03921658
• Other study ID #: 2019NTLS030
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Inflammation
• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma

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