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

This study has been withdrawn prior to enrollment.
(no patient accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00460200
First received: April 11, 2007
Last updated: October 3, 2012
Last verified: October 2012

April 11, 2007
October 3, 2012
December 2003
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  • 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 [ Designated as safety issue: No ]
  • Correlation of tumor culture supernatant, ascitic fluid, and/or serum IL-6 level with levels of depression and/or anxiety [ Designated as safety issue: No ]
  • Effects of neuroendocrine activity on modulation of IL-6 production [ Designated as safety issue: No ]
  • Comparison of immune response to autologous tumor tissue in "MLR-like" reactions between tumor and peripheral blood mononuclear cells in vitro [ Designated as safety issue: No ]
  • Correlation of levels of immunologic response with relapse and/or survival times, clinical response to CA 125 antibody treatment, and IL-6 parameters [ Designated as safety issue: No ]
  • Establishment of a major histocompatibility complex (MHC) tetramer assay for assessing cytotoxic T lymphocyte levels in peripheral blood [ Designated as safety issue: No ]
  • Incidence of herpes virus infections [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00460200 on ClinicalTrials.gov Archive Site
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Depression and Interleukin-6 Production in Patients With Ovarian Epithelial Cancer
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.

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.

Observational
Time Perspective: Prospective
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Non-Probability Sample

diagnosis of ovarian epithelial cancer

  • Depression
  • Fatigue
  • Ovarian Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Sleep Disorders
  • Genetic: polymorphism analysis
  • Other: laboratory biomarker analysis
  • Other: physiologic testing
  • Other: questionnaire administration
  • Procedure: conventional surgery
  • Procedure: fatigue assessment and management
  • Procedure: psychosocial assessment and care
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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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
Female
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00460200
CDR0000385692, UCLA-0309083-01, UCLA-002
No
Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Leah Z. Fitzgerald, RN, PhD Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP