Trial Outcomes & Findings for Tumor Gene Expression in Women With Ovarian Cancer (NCT NCT00817479)

NCT ID: NCT00817479

Last Updated: 2016-07-13

Results Overview

Increase in SGK1 mRNA expression level is calculated as fold change = post / pre

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: >= 30 min
• Results posted on: 2016-07-13

Participant Flow

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.

Participant milestones

Measure	Placebo Placebo \[saline\]	Dexamethasone 20 mg dexamethasone IV push
Overall Study STARTED	6	14
Overall Study COMPLETED	5	13
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Placebo Placebo \[saline\]	Dexamethasone 20 mg dexamethasone IV push
Overall Study Physician Decision	1	1

Baseline Characteristics

Tumor Gene Expression in Women With Ovarian Cancer

Baseline characteristics by cohort

Measure	Placebo n=6 Participants Placebo \[saline\]	Dexamethasone n=14 Participants 20 mg dexamethasone IV push	Total n=20 Participants Total of all reporting groups
Age, Continuous	61 years n=5 Participants	53.5 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: >= 30 min

Population: Eighteen of the 20 randomized patients received treatment. Eight of the treated patients were unevaluable because there was not enough tissue available during surgery for experimental studies; the remaining 10 patients had adequate tissue samples at baseline and at least at 30 minutes following dexamethasone/normal saline administration.

Increase in SGK1 mRNA expression level is calculated as fold change = post / pre

Outcome measures

Measure	Placebo n=5 Participants Placebo \[saline\]	Dexamethasone n=5 Participants 20 mg dexamethasone IV push
Increase in SGK1 mRNA Expression Level	1.5 fold change Standard Error 0.4	6.1 fold change Standard Error 2.6

PRIMARY outcome

Timeframe: >= 30 min

Population: Eighteen of the 20 randomized patients received treatment. Eight of the treated patients were unevaluable because there was not enough tissue available during surgery for experimental studies; the remaining 10 patients had adequate tissue samples at baseline and at least at 30 minutes following dexamethasone/normal saline administration.

Increase in MKP1/DuSP1 mRNA expression level is calculated as fold change = post / pre

Outcome measures

Measure	Placebo n=5 Participants Placebo \[saline\]	Dexamethasone n=5 Participants 20 mg dexamethasone IV push
Increase in MKP1/DuSP1 mRNA Expression Level	1.1 fold change Standard Error 0.4	8.2 fold change Standard Error 2.9

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gini Fleming, MD

The University of Chicago, Department of Medicine

Phone: (773) 702-6149

Email: gfleming@medicine.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place