DepressionNCT00460200
Depression and Interleukin-6 Production in Patients With Ovarian Epithelial Cancer
An observational study of Depression and Fatigue, run by Jonsson Comprehensive Cancer Center.
Trial summary
RATIONALE: Measuring levels of interleukin-6 and depression may help doctors understand the relationship between interleukin-6 and depression. It may also help the study of cancer in the future. PURPOSE: This clinical trial is studying depression and interleukin-6 production in patients with ovarian epithelial cancer. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Depression, Fatigue, Ovarian Cancer
- What is being tested?
- polymorphism analysis, laboratory biomarker analysis and physiologic testing
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to not given
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: diagnosis of ovarian epithelial cancer
DISEASE CHARACTERISTICS:
- Diagnosis of ovarian epithelial cancer
- Scheduled to undergo cytoreduction of ovarian tumor
PATIENT CHARACTERISTICS:
- Able to communicate with the investigator
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Depression and IL-6 in Epithelial Ovarian Cancer: Genetic Diathesis and Psychological Stress
RATIONALE: Measuring levels of interleukin-6 and depression may help doctors understand the relationship between interleukin-6 and depression. It may also help the study of cancer in the future.
PURPOSE: This clinical trial is studying depression and interleukin-6 production in patients with ovarian epithelial cancer.
Read the detailed description
OBJECTIVES:
- Correlate tumor production of interleukin (IL)-6, serum levels of IL-6, and IL-6 coding or promoter single nucleotide polymorphisms with IL-6 protein production in patients with ovarian epithelial cancer.
- Correlate tumor culture supernatant, ascitic fluid, and/or serum IL-6 level with levels of depression and/or anxiety in these patients to determine whether catecholamines or cortisol may alter production of IL-6 by cultured ovarian cancer cells.
- Determine the effects of neuroendocrine activity on modulation of IL-6 production in these patients.
- Compare immune response to autologous tumor tissue in "MLR-like" reactions between tumor and peripheral blood mononuclear cells in vitro.
- Correlate the levels of immunologic response with relapse and/or survival times, clinical response to CA 125 antibody treatment (e.g., in a pre- vs post-therapy sampling framework), and IL-6 parameters in these patients.
- Determine the use of epitope prediction bioinformatic tools in consultation with Coulter to set up a major histocompatibility complex (MHC) tetramer assay for assessing cytotoxic T lymphocyte levels in peripheral blood from these patients.
- Determine the incidence of herpes virus infections in these patients.
OUTLINE: This is a pilot study.
Before and after cytoreduction surgery, patients complete multiple questionnaires, including Beck Depression Inventory, Positive \& Negative Mood State, Fatigue Symptom Inventory, Revised NEO Personality Inventory, COPE, SF-36, Pittsburgh Sleep Quality Inventory, and Mental Adjustment to Cancer, to assess depression and coping mechanisms.
Blood samples are collected at baseline and on postoperative days 1-4 and analyzed for interleukin (IL)-6, c-reactive protein, herpes simplex virus-8 (HSV8), epinephrine, adrenocorticotropic hormones, and cortisol. Ovarian carcinoma tissue samples and peritoneal fluid are also collected and evaluated for production and utilization of IL-6, HSV8, and autonomic nervous system and hypothalamic-pituitary-adrenal activity.
PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study.
- Conditions
- Depression, Fatigue, Ovarian Cancer, Psychosocial Effects of Cancer and Its Treatment, Sleep Disorders
- Being tested
- polymorphism analysis, laboratory biomarker analysis, physiologic testing, questionnaire administration, conventional surgery
- Keywords
- depression, fatigue, sleep disorders, psychosocial effects of cancer and its treatment, ovarian epithelial cancer
- Medical subject headings
- Depression, Fatigue, Ovarian Neoplasms, Sleep Wake Disorders, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polymorphism analysisGenetic
laboratory biomarker analysisOther
physiologic testingOther
questionnaire administrationOther
conventional surgeryProcedure or surgery
fatigue assessment and managementProcedure or surgery
psychosocial assessment and careProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of tumor production of interleukin (IL)-6, serum levels of IL-6, and IL-6 coding or promoter single nucleotide polymorphisms with IL-6 protein production
Correlation of tumor culture supernatant, ascitic fluid, and/or serum IL-6 level with levels of depression and/or anxiety
Effects of neuroendocrine activity on modulation of IL-6 production
Comparison of immune response to autologous tumor tissue in "MLR-like" reactions between tumor and peripheral blood mononuclear cells in vitro
Correlation of levels of immunologic response with relapse and/or survival times, clinical response to CA 125 antibody treatment, and IL-6 parameters
Establishment of a major histocompatibility complex (MHC) tetramer assay for assessing cytotoxic T lymphocyte levels in peripheral blood
Incidence of herpes virus infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startDec 2003
Why it stopped: no patient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Leah Z. Fitzgerald, RN, PhD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460200
- Sponsor's protocol ID
- CDR0000385692
- Other IDs
- UCLA-0309083-01, UCLA-002
- Status last verified
- Oct 2012
- First submitted
- 11 Apr 2007
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression and IL-6 in Epithelial Ovarian Cancer: Genetic Diathesis and Psychological Stress
- ClinicalTrials.gov ID
- NCT00460200
- Acronym / sponsor ID
- CDR0000385692
- Conditions
- Depression, Fatigue, Ovarian Cancer, Psychosocial Effects of Cancer and Its Treatment, Sleep Disorders
- Keywords
- depression, fatigue, sleep disorders, psychosocial effects of cancer and its treatment, ovarian epithelial cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no patient accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2003
- First posted
- 13 Apr 2007 (estimated)
- 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.
RATIONALE: Measuring levels of interleukin-6 and depression may help doctors understand the relationship between interleukin-6 and depression. It may also help the study of cancer in the future.
PURPOSE: This clinical trial is studying depression and interleukin-6 production in patients with ovarian epithelial cancer.
Detailed description
OBJECTIVES:
- Correlate tumor production of interleukin (IL)-6, serum levels of IL-6, and IL-6 coding or promoter single nucleotide polymorphisms with IL-6 protein production in patients with ovarian epithelial cancer.
- Correlate tumor culture supernatant, ascitic fluid, and/or serum IL-6 level with levels of depression and/or anxiety in these patients to determine whether catecholamines or cortisol may alter production of IL-6 by cultured ovarian cancer cells.
- Determine the effects of neuroendocrine activity on modulation of IL-6 production in these patients.
- Compare immune response to autologous tumor tissue in "MLR-like" reactions between tumor and peripheral blood mononuclear cells in vitro.
- Correlate the levels of immunologic response with relapse and/or survival times, clinical response to CA 125 antibody treatment (e.g., in a pre- vs post-therapy sampling framework), and IL-6 parameters in these patients.
- Determine the use of epitope prediction bioinformatic tools in consultation with Coulter to set up a major histocompatibility complex (MHC) tetramer assay for assessing cytotoxic T lymphocyte levels in peripheral blood from these patients.
- Determine the incidence of herpes virus infections in these patients.
OUTLINE: This is a pilot study.
Before and after cytoreduction surgery, patients complete multiple questionnaires, including Beck Depression Inventory, Positive \& Negative Mood State, Fatigue Symptom Inventory, Revised NEO Personality Inventory, COPE, SF-36, Pittsburgh Sleep Quality Inventory, and Mental Adjustment to Cancer, to assess depression and coping mechanisms.
Blood samples are collected at baseline and on postoperative days 1-4 and analyzed for interleukin (IL)-6, c-reactive protein, herpes simplex virus-8 (HSV8), epinephrine, adrenocorticotropic hormones, and cortisol. Ovarian carcinoma tissue samples and peritoneal fluid are also collected and evaluated for production and utilization of IL-6, HSV8, and autonomic nervous system and hypothalamic-pituitary-adrenal activity.
PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- diagnosis of ovarian epithelial cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polymorphism analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| physiologic testing | Other | – |
| questionnaire administration | Other | – |
| conventional surgery | Procedure or surgery | – |
| fatigue assessment and management | Procedure or surgery | – |
| psychosocial assessment and care | Procedure or surgery | – |
Primary outcome
Correlation of tumor production of interleukin (IL)-6, serum levels of IL-6, and IL-6 coding or promoter single nucleotide polymorphisms with IL-6 protein production
Correlation of tumor culture supernatant, ascitic fluid, and/or serum IL-6 level with levels of depression and/or anxiety
Effects of neuroendocrine activity on modulation of IL-6 production
Comparison of immune response to autologous tumor tissue in "MLR-like" reactions between tumor and peripheral blood mononuclear cells in vitro
Correlation of levels of immunologic response with relapse and/or survival times, clinical response to CA 125 antibody treatment, and IL-6 parameters
Establishment of a major histocompatibility complex (MHC) tetramer assay for assessing cytotoxic T lymphocyte levels in peripheral blood
Incidence of herpes virus infections
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
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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.
Leah Z. Fitzgerald, RN, PhD principal investigator
Jonsson Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Fatigue, run by Jonsson Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Correlation of tumor production of interleukin (IL)-6, serum levels of IL-6, and IL-6 coding or promoter single nucleotide polymorphisms with IL-6 protein production. The study lists 7 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 4 Oct 2012.