Ovarian CancerNCT03921658
The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
An observational study of Ovarian Cancer and Fallopian Tube Cancer, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2019to 2 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Inability to provide informed written consent
- Previous exposure to chemotherapy
- Life expectancy < 3 months or in hospice care or nursing home
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start22 Oct 2019
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921658
- Sponsor's protocol ID
- 2019NTLS030
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2019
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03921658
- Acronym / sponsor ID
- 2019NTLS030
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Inability to provide informed written consent
- Previous exposure to chemotherapy
- Life expectancy < 3 months or in hospice care or nursing home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Fallopian Tube Cancer, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1 - Cancer-related fatigue (time frame: post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.