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出境医 / 临床实验 / The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
Study Description
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 |
Study Design
| 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 22, 2019 |
| Estimated Primary Completion Date : | October 31, 2022 |
| Estimated Study Completion Date : | October 31, 2023 |
Arms and Interventions
| Group/Cohort |
|---|
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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
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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)
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Outcome Measures
Primary Outcome Measures :
- 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
Biospecimen Retention: Samples With DNA
Blood samples at up to 3 time points
Eligibility Criteria
| 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
Contacts and Locations
Locations
| 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
United States Department of Defense
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 16, 2019 | ||||
| First Posted Date | April 19, 2019 | ||||
| Last Update Posted Date | September 4, 2020 | ||||
| Actual Study Start Date | October 22, 2019 | ||||
| Estimated Primary Completion Date | October 31, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer | ||||
| Official Title | The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer | ||||
| 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:
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description:
Blood samples at up to 3 time points
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| 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 | ||||
| Condition |
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
350 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | October 31, 2023 | ||||
| Estimated Primary Completion Date | October 31, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | |||||
| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03921658 | ||||
| Other Study ID Numbers | 2019NTLS030 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University of Minnesota | ||||
| Study Sponsor | University of Minnesota | ||||
| Collaborators | United States Department of Defense | ||||
| Investigators | Not Provided | ||||
| PRS Account | University of Minnesota | ||||
| Verification Date | September 2020 | ||||
