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

This study has been withdrawn prior to enrollment.
(no patient accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00460200
First Posted: April 13, 2007
Last Update Posted: October 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
April 11, 2007
April 13, 2007
October 4, 2012
December 2003
Not Provided
  • 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
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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
Sexes Eligible for Study: Female
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00460200
CDR0000385692
UCLA-0309083-01
UCLA-002
No
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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