Clinical trial · Interventional
Tumor Gene Expression in Women With Ovarian Cancer
Tumor Gene Expression Before and After Intraoperative Dexamethasone in Women With Ovarian Cancer
NCT00817479CI-TRIAL-00023013completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Dexamethasone
- description
- 20 mg of dexamethasone
- interventionNames
- Drug: Dexamethasone
- type
- PLACEBO_COMPARATOR
- label
- Placebo [Saline]
- description
- Saline
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
- Increase in SGK1 mRNA Expression Level
- timeFrame
- >= 30 min
- description
- Increase in SGK1 mRNA expression level is calculated as fold change = post / pre
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTMelhem A, Yamada SD, Fleming GF, Delgado B, Brickley DR, Wu W, Kocherginsky M, Conzen SD. Administration of glucocorticoids to ovarian cancer patients is associated with expression of the anti-apoptotic genes SGK1 and MKP1/DUSP1 in ovarian tissues. Clin Cancer Res. 2009 May 1;15(9):3196-204. doi: 10.1158/1078-0432.CCR-08-2131. Epub 2009 Apr 21. PMID 19383827