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

NCT03921658 | Completed

• 1 other identifier: 2019NTLS030
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Inability to provide informed written consent
• Previous exposure to chemotherapy
• Life expectancy \< 3 months or in hospice care or nursing home

Sponsors & Collaborators

• University of Minnesota: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples at up to 3 time points

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: October 22, 2019
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)