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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 : October 14, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief 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.

Condition or disease
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2023


Group/Cohort
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)



Primary Outcome Measures :
  1. 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.

  2. 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
Blood samples at up to 3 time points


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals diagnosed and/or treated for ovarian/Fallopian tube/primary peritoneal cancer by physicians in the Gynecologic Oncology Clinic at the University of Minnesota
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Rachel I Vogel, PhD    612-624-6928    isak0023@umn.edu   
Principal Investigator: Rachel I Vogel, PhD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
United States Department of Defense

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03921658     History of Changes
Other Study ID Numbers: STUDY00005451
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Inflammation
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases