Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460200
Status:
WITHDRAWN
Last Update Posted:
2012-10-04
First Post:
2007-04-11
Brief Title:
Depression and Interleukin-6 Production in Patients With Ovarian Epithelial Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Depression and IL-6 in Epithelial Ovarian Cancer Genetic Diathesis and Psychological Stress
Status:
WITHDRAWN
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no patient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor serum IL-6 level with levels of depression andor 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 andor survival times clinical response to CA 125 antibody treatment eg 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
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 andor serum IL-6 level with levels of depression andor 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 andor survival times clinical response to CA 125 antibody treatment eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-002 | None | None | None |
| UCLA-0309083-01 | None | None | None |