Tumor Gene Expression in Women With Ovarian Cancer

June 2, 2016 updated by: University of Chicago

Tumor Gene Expression Before and After Intraoperative Dexamethasone in Women With Ovarian Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone
20 mg of dexamethasone
Drug: Dexamethasone
20 MG OF DEXAMETHASONE OR PLACEBO
Placebo Comparator: Placebo [Saline]
Saline
Drug: Placebo
Placebo saline
Other Names:
  • Saline Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in SGK1 mRNA Expression Level
Time Frame: >= 30 min
Increase in SGK1 mRNA expression level is calculated as fold change = post / pre
>= 30 min
Increase in MKP1/DuSP1 mRNA Expression Level
Time Frame: >= 30 min
Increase in MKP1/DuSP1 mRNA expression level is calculated as fold change = post / pre
>= 30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Study Chair: Gini Fleming, MD, 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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 5, 2009

First Submitted That Met QC Criteria

January 5, 2009

First Posted (Estimate)

January 6, 2009

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

June 2, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11892A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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