Phase 4
N=20
Tumor Gene Expression in Women With Ovarian Cancer
Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00817479 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Increase in SGK1 mRNA Expression Level — 1.5; 6.1 fold change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexamethasone (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Chicago
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Increase in SGK1 mRNA Expression Level |
1.5; 6.1 | — |
| PRIMARY Increase in MKP1/DuSP1 mRNA Expression Level |
1.1; 8.2 | — |
Summary
The study objective is to compare changes in expression of glucocorticoid-induced genes that may be involved in cell survival signaling in the tumors of ovarian cancer patients before and after an intraoperative dose of 20mg dexamethasone.
Eligibility Criteria
Inclusion Criteria
- Subject has intraabdominal disease either proven or strongly suspected to be ovarian or primary peritoneal cancer, and will be undergoing surgical debulking.
- Subject is not allergic to dexamethasone, and there is no obvious medical contraindication to dexamethasone.
- Subjects with diabetes requiring drug therapy are excluded.
- Subject is not currently receiving glucocorticoid therapy
- Nasal steroids (e.g. Flonase) are permitted
- Subject understands that this protocol does not have therapeutic intent
- Preoperative serum albumin at least 3.0 mg/dL
- Negative serum or urine pregnancy test in women of childbearing potential
- Signed informed consent
Exclusion Criteria
- Males do not get ovarian cancer and therefore will not be included in this trial.
- Patients of all ethnic backgrounds are eligible and will be encouraged to enroll. However we do not expect differences based on ethnicity, and this small study will not therefore be powered to make conclusions about ethnic differences in induction of GR-regulated genes with dexamethasone.
Data sourced from ClinicalTrials.gov (NCT00817479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.