Ovarian CancerPhase 4NCT00817479
Tumor Gene Expression in Women With Ovarian Cancer
A Phase 4 study testing Dexamethasone in people with Ovarian Cancer, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jan 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- Preoperative serum albumin at least 3.0 mg/dL
- Negative serum or urine pregnancy test in women of childbearing potential
- Signed informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- Dexamethasone, Placebo
- Keywords
- Subject has intraabdominal disease either proven or strongly, suspected to be ovarian or primary peritoneal cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
20 MG OF DEXAMETHASONE OR PLACEBO
PlaceboDrug
Also called Saline Placebo
Placebo saline
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | 20 mg of dexamethasone Receives: Drug: Dexamethasone |
| Placebo [Saline] | Placebo comparator | Saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in SGK1 mRNA Expression Level
Increase in SGK1 mRNA expression level is calculated as fold change = post / pre
Measured: >= 30 min
Increase in MKP1/DuSP1 mRNA Expression Level
Increase in MKP1/DuSP1 mRNA expression level is calculated as fold change = post / pre
Measured: >= 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startJan 2003
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gini Fleming, MD, Study chair, 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817479
- Sponsor's protocol ID
- 11892A
- Status last verified
- Jun 2016
- First submitted
- 5 Jan 2009
- Last updated
- 13 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 19383827
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Gene Expression Before and After Intraoperative Dexamethasone in Women With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00817479
- Acronym / sponsor ID
- 11892A
- Conditions
- Ovarian Cancer
- Keywords
- Subject has intraabdominal disease either proven or strongly, suspected to be ovarian or primary peritoneal cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 6 Jan 2009 (estimated)
- Results
- Posted 13 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: Dexamethasone20 mg of dexamethasone |
| Placebo [Saline] | Placebo comparator | Drug: PlaceboSaline |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone20 MG OF DEXAMETHASONE OR PLACEBO | Drug | Dexamethasone |
| PlaceboAlso: Saline PlaceboPlacebo saline | Drug | Placebo [Saline] |
Primary outcome
Increase in SGK1 mRNA Expression Level
Time frame: >= 30 min
Increase in SGK1 mRNA expression level is calculated as fold change = post / pre
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19383827Melhem 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gini Fleming, MD study chair
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Ovarian Cancer, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in SGK1 mRNA Expression Level (time frame: >= 30 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00817479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.