Tumor Gene Expression in Women With Ovarian Cancer

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. Identifier: NCT00817479
Recruitment Status : Completed
First Posted : January 6, 2009
Results First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Information provided by (Responsible Party):
University of Chicago

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Ovarian Cancer
Interventions: Drug: Dexamethasone
Drug: Placebo

  Participant Flow

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

Participant Flow:   Overall Study
    Placebo   Dexamethasone
STARTED   6   14 
COMPLETED   5   13 
Physician Decision                1                1 

  Baseline Characteristics

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

Baseline Measures
   Placebo   Dexamethasone   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   14   20 
[Units: Years]
Median (Full Range)
 (46 to 80) 
 (44 to 73) 
 (44 to 80) 
[Units: Participants]
Female   6   14   20 
Male   0   0   0 

  Outcome Measures

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

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

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

Publications of Results:

Responsible Party: University of Chicago Identifier: NCT00817479     History of Changes
Other Study ID Numbers: 11892A
First Submitted: January 5, 2009
First Posted: January 6, 2009
Results First Submitted: June 2, 2016
Results First Posted: July 13, 2016
Last Update Posted: July 13, 2016