Clinical trial · Observational
The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1 - Cross-sectional (within 2 years of diagnosis)
- description
- Individuals diagnosed and treated for ovarian cancer in past two years, will complete 1 study measure
- label
- Cohort 2- Prospective (from diagnosis)
- description
- Individuals newly diagnosed with ovarian cancer, will complete 3 study measures (baseline/diagnosis, completion of chemotherapy, one year post-diagnosis)
Primary outcomes (2)
- measure
- Cohort 1 - Cancer-related fatigue
- timeFrame
- post treatment
- description
- 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.
- measure
- Cohort 2 - Recurrence-free survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available