NCT02520115

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

Completed Phase 1 Last updated 12 August 2019

What this trial tests

Phase 1 trial testing Dexamethasone in Adnexal Mass in 50 participants. Completed in 1 November 2018.

Timeline

1 August 2015

Primary endpoint
1 September 2018

1 November 2018

Quick facts

Lead sponsor	Barbara Ann Karmanos Cancer Institute
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 August 2015
Primary completion	1 September 2018
Estimated completion	1 November 2018
Sites	2 locations across United States

Drugs / interventions tested

• Dexamethasone (dexamethasone) — full drug profile →
• Laboratory Biomarker Analysis — full drug profile →
• Valproic Acid (valproic acid) — full drug profile →

Conditions studied

• Adnexal Mass — all drugs for Adnexal Mass →
• Borderline Ovarian Epithelial Tumor — all drugs for Borderline Ovarian Epithelial Tumor →
• Ovarian Clear Cell Tumor — all drugs for Ovarian Clear Cell Tumor →
• Ovarian Endometrioid Tumor — all drugs for Ovarian Endometrioid Tumor →

Sponsor

Barbara Ann Karmanos Cancer Institute

Who can join

18 and older, female only, with Adnexal Mass or Borderline Ovarian Epithelial Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Arm I: To evaluate the ability to increase serum Folate Receptor (FR) levels in patients with newly diagnosed adnexal masses or ovarian cancer utilizing Dexamethasone (DEX) and Valproic Acid (VA).
  Time frame: Up to 14 days after induction
  FR will be measured in the serum of patients utilizing a standardized tritiated folate/charcoal binding assay pre- and post-drug administration. This will be measured to the femto-molar level. Two sided t-tests will be utilized as a baseline statistical analysis to determine the efficacy of induction in this setting.
• Arm I: To evaluate the utility of serum FR to distinguish between patients with benign masses or malignancy.
  Time frame: Up to 14 days after surgery
  Folate receptor levels in patients with benign and malignant conditions will be compared utilizing receiver operator curves for both pre- and post-induction levels to determine if soluble folate receptor can be utilized as a tumor marker in newly diagnosed adnexal masses and/or ovarian cancer. Both two-sided t tests and ROC curve analysis will be utilized in this portion of the analysis.
• Arm II: To evaluate the use of the serum soluble FR as a marker for earlier detection of recurrent disease.
  Time frame: Up to 14 days after induction
  Patients are to be followed during surveillance period for a history of know ovarian carcinoma with serum FR in addition to CA-125. FR will again be measured in the serum of patients utilizing a standardized tritiated folate/charcoal binding assay. This will be measured to the femto-molar level. ROC curve analysis will be performed to evaluate the efficacy of baseline Folate Receptor in early dete
• Arm II: To evaluate the ability to increase serum FR levels with DEX and VA in the setting of recurrent disease.
  Time frame: Up to 14 days after surgery
  If recurrence is suspected, this portion of Arm 2 is meant to determine if serum levels of FR can be artificially increased in the recurrent setting utilizing DEX and VA above baseline recurrent levels. FR will be measured in the serum of patients utilizing a standardized tritiated folate/charcoal binding assay pre- and post-drug administration. This will be measured to the femto-molar level. Two

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Folate Receptor Alpha-A Novel Approach to Cancer Therapy.
   Gonzalez T, Muminovic M, Nano O, Vulfovich M. · · 2024 · cited 52× · PMID 38256120 · DOI 10.3390/ijms25021046
2. Potential of histone deacetylase inhibitors for the therapy of ovarian cancer.
   Guo F, Wang H. · · 2022 · cited 11× · PMID 36505774 · DOI 10.3389/fonc.2022.1057186