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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Primary Peritoneal Carcinoma Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

United States Department of Defense

Registry information

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2024
First posted: Apr 19, 2019
Registry last updated: Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed