Tumor Gene Expression in Women With Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00817479
First received: January 5, 2009
Last updated: June 2, 2016
Last verified: June 2016
Results First Received: June 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Ovarian Cancer
Interventions: Drug: Dexamethasone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled between July 2003 and September 2007 through the Gynecologic Oncology Clinic at the University of Chicago subject to the inclusion and exclusion criteria described in the registration record.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo [saline]
Dexamethasone 20 mg dexamethasone IV push

Participant Flow:   Overall Study
    Placebo     Dexamethasone  
STARTED     6     14  
COMPLETED     5     13  
NOT COMPLETED     1     1  
Physician Decision                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo [saline]
Dexamethasone 20 mg dexamethasone IV push
Total Total of all reporting groups

Baseline Measures
    Placebo     Dexamethasone     Total  
Number of Participants  
[units: participants]
  6     14     20  
Age  
[units: years]
Median (Full Range)
  61  
  (46 to 80)  
  53.5  
  (44 to 73)  
  56  
  (44 to 80)  
Gender  
[units: participants]
     
Female     6     14     20  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Increase in SGK1 mRNA Expression Level   [ Time Frame: >= 30 min ]

2.  Primary:   Increase in MKP1/DuSP1 mRNA Expression Level   [ Time Frame: >= 30 min ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Gini Fleming, MD
Organization: The University of Chicago, Department of Medicine
phone: (773) 702-6149
e-mail: gfleming@medicine.bsd.uchicago.edu


Publications of Results:

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00817479     History of Changes
Other Study ID Numbers: 11892A
Study First Received: January 5, 2009
Results First Received: June 2, 2016
Last Updated: June 2, 2016
Health Authority: United States: Institutional Review Board