NCT00817479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 ovarian-cancer

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_4 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

July 13, 2016

Completed
Last Updated

July 13, 2016

Status Verified

June 1, 2016

Enrollment Period

10 years

First QC Date

January 5, 2009

Results QC Date

June 2, 2016

Last Update Submit

June 2, 2016

Conditions

Ovarian Cancer

Keywords

Subject has intraabdominal disease either proven or stronglysuspected to be ovarian or primary peritoneal cancer

Outcome Measures

Primary Outcomes (2)

  • Increase in SGK1 mRNA Expression Level

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

    >= 30 min

  • Increase in MKP1/DuSP1 mRNA Expression Level

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

    >= 30 min

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

20 mg of dexamethasone

Drug: Dexamethasone

Placebo [Saline]

PLACEBO COMPARATOR

Saline

Drug: Placebo

Interventions

DexamethasoneDRUG

20 MG OF DEXAMETHASONE OR PLACEBO

Dexamethasone
PlaceboDRUG

Placebo saline

Also known as: Saline Placebo
Placebo [Saline]

Eligibility Criteria

Age18 Years - 59 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • 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.

    PMID: 19383827RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Dr. Gini Fleming, MD
Organization
The University of Chicago, Department of Medicine
gfleming@medicine.bsd.uchicago.edu
(773) 702-6149

Study Officials

  • 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.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2009

First Posted

January 6, 2009

Study Start

January 1, 2003

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 13, 2016

Results First Posted

July 13, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)