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Spots Global Cancer Trial Database for Depression and Interleukin-6 Production in Patients With Ovarian Epithelial Cancer

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Trial Identification

Brief Title: Depression and Interleukin-6 Production in Patients With Ovarian Epithelial Cancer

Official Title: Depression and IL-6 in Epithelial Ovarian Cancer: Genetic Diathesis and Psychological Stress

Study ID: NCT00460200

Study Description

Brief 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.

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

Name: Leah Z. Fitzgerald, RN, PhD

Affiliation: Jonsson Comprehensive Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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