Clinical Trials Directory

Trials / Completed

CompletedNCT02520115

Folate Receptor in Diagnosing Ovarian Cancer Using Serum Samples From Patients With Newly Diagnosed Pelvic Mass or Previously Diagnosed Ovarian Cancer

Study of Serum Measured Folate Receptor and Its Induction as a Biomarker in the Diagnosis and Surveillance of Ovarian Carcinoma

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Barbara Ann Karmanos Cancer Institute · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This pilot research trial studies folate receptor in diagnosing ovarian cancer using serum samples from patients with a newly diagnosed pelvic mass or previously diagnosed ovarian cancer. Studying samples of serum from patients with ovarian cancer in the laboratory may help understand the use of folate receptor induction as a clinical tool in initial diagnosis, surveillance, and recurrence.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the pre- and post-induction correlation between soluble folate receptor and tumor-based receptor levels as a marker of malignancy in patients with newly diagnosed adnexal masses. (Arm I) II. To evaluate the ability to induce serum folate receptor (FR) with dexamethasone (Dex) and valproic acid (VPA) treatment in patients with newly diagnosed adnexal masses. (Arm I) III. To evaluate the use of the serum soluble FR as a marker for earlier detection of recurrent disease. (Arm II) IV. To evaluate the ability to induce FR with Dex and VPA in the setting of recurrent disease. (Arm II) SECONDARY OBJECTIVES: I. To evaluate the expression of FR in primary versus (vs.) metastatic tumor sites in patients with ovarian malignancy undergoing Dex and VPA induction and correlate expression with other markers associated with malignancy (marker of proliferation Ki-67 \[Ki67\], cancer antigen \[CA\]-125, etc.). II. To analyze the correlation between gluco-corticoid receptor (GR) levels and serum FR induction efficacy. III. To examine global, downstream targets of GR and FR induction in patient samples undergoing treatment with Dex and VPA. OUTLINE: Patients are assigned to 1 of 2 arms. ARM I (INDUCTION): Patients receive valproic acid orally (PO) twice daily (BID) on days -7 to -3 and once daily (QD) on day -2 and dexamethasone PO QD on days -5 and -2 and BID on days -4 and -3. Patients undergo collection of serum and tissue samples for analysis via polymerase chain reaction (PCR) and immunohistochemistry (IHC) at baseline, time of surgery, and 7-14 days after surgery. ARM II (SURVEILLANCE AND RECURRENCE): Patients receive valproic acid PO BID on days -7 to -3 and QD on day -2 and dexamethasone PO QD on days -5 and -2 and BID on days -4 and -3. Patients undergo collection of serum and tissue samples for analysis via PCR and IHC at the time of clinically suspected recurrence, 2 days after completion of induction, and 7-14 days after induction.

Conditions

Interventions

TypeNameDescription
DRUGDexamethasoneGiven PO
OTHERLaboratory Biomarker AnalysisAnalysis of serum and tissue samples
DRUGValproic AcidGiven PO

Timeline

Start date
2015-08-01
Primary completion
2018-09-01
Completion
2018-11-01
First posted
2015-08-11
Last updated
2019-08-14

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02520115. Inclusion in this directory is not an endorsement.