NCT00460200

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2007

Completed
Last Updated

October 4, 2012

Status Verified

October 1, 2012

First QC Date

April 11, 2007

Last Update Submit

October 3, 2012

Conditions

DepressionFatigueOvarian CancerPsychosocial Effects of Cancer and Its TreatmentSleep Disorders

Keywords

depressionfatiguesleep disorderspsychosocial effects of cancer and its treatmentovarian epithelial cancer

Outcome Measures

Primary Outcomes (7)

  • 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

Interventions

polymorphism analysisGENETIC
laboratory biomarker analysisOTHER
physiologic testingOTHER
questionnaire administrationOTHER
conventional surgeryPROCEDURE
fatigue assessment and managementPROCEDURE
psychosocial assessment and carePROCEDURE

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionFatigueOvarian NeoplasmsSleep Wake DisordersCarcinoma, Ovarian Epithelial

Interventions

Amplified Fragment Length Polymorphism AnalysisTherapeuticsPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersNervous System DiseasesNeurologic ManifestationsMental DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

DNA FingerprintingGenetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification TechniquesRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Leah Z. Fitzgerald, RN, PhD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2007

First Posted

April 13, 2007

Study Start

December 1, 2003

Last Updated

October 4, 2012

Record last verified: 2012-10