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Tumor Gene Expression in Women With Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ovarian Cancer focused on measuring Subject has intraabdominal disease either proven or strongly, suspected to be ovarian or primary peritoneal cancer

Eligibility Criteria

18 Years - 59 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone

Placebo [Saline]

Arm Description

20 mg of dexamethasone

Saline

Outcomes

Primary Outcome Measures

Increase in SGK1 mRNA Expression Level
Increase in SGK1 mRNA expression level is calculated as fold change = post / pre
Increase in MKP1/DuSP1 mRNA Expression Level
Increase in MKP1/DuSP1 mRNA expression level is calculated as fold change = post / pre

Secondary Outcome Measures

Full Information

First Posted
January 5, 2009
Last Updated
June 2, 2016
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00817479
Brief Title
Tumor Gene Expression in Women With Ovarian Cancer
Official Title
Tumor Gene Expression Before and After Intraoperative Dexamethasone in Women With Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
This trial will examine the upregulation of dexamethasone-inducible genes in the tumors of ovarian cancer patients undergoing surgical debulking. A core biopsy of tumor will be taken at the first opportune time during surgery. Dexamethasone 20 mg IV will then be administered, and a second biopsy taken 30 minutes later. Samples at two and four hours later will also be obtained if surgery is still in progress and biopsiable tumor remains. Tissue will be snap-frozen. Subsequently tumor will be microdissected out from stroma, and tumor RNA will be extracted for gene expression profiling. Sixteen patients with epithelial ovarian cancer receiving dexamethasone will be studied, and an additional eight patients with epithelial ovarian cancer will receive a small saline (placebo) injection and serve as controls. Enrollment is limited to those patients with a serum albumin of at least 3.0 g/dL to minimize any theoretical adverse effect of a single dose of dexamethasone on wound healing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Subject has intraabdominal disease either proven or strongly, suspected to be ovarian or primary peritoneal cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
20 mg of dexamethasone
Arm Title
Placebo [Saline]
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
20 MG OF DEXAMETHASONE OR PLACEBO
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline Placebo
Intervention Description
Placebo saline
Primary Outcome Measure Information:
Title
Increase in SGK1 mRNA Expression Level
Description
Increase in SGK1 mRNA expression level is calculated as fold change = post / pre
Time Frame
>= 30 min
Title
Increase in MKP1/DuSP1 mRNA Expression Level
Description
Increase in MKP1/DuSP1 mRNA expression level is calculated as fold change = post / pre
Time Frame
>= 30 min

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gini Fleming, MD
Organizational Affiliation
Gralla, R. J., Osoba, D., Kris, M. G., Kirkbride, P., Hesketh, P. J., et al.: Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines. American Society of Clinical Oncology. J Clin Oncol 1999; 17(9): 2971-94.
Official's Role
Study Chair
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19383827
Citation
Melhem 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.
Results Reference
result

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Tumor Gene Expression in Women With Ovarian Cancer

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