Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer
- Registration Number
- NCT00699907
- Lead Sponsor
- University of Arizona
- Brief Summary
Studying samples of blood and tissue in the laboratory from patients with a high risk of developing ovarian cancer may help doctors identify and learn more about biomarkers related to cancer. We hypothesized that (i) preclinical biologic evidence exists for the role of androgens in ovarian cancer development and (ii) flutamide treatment of women at high risk for ovarian cancer may identify meaningful tissue biomarkers of androgen action and of ovarian cancer initiation. This phase II trial studied the effect of flutamide on biomarkers in blood and tissue samples from patients at high risk of ovarian cancer.
- Detailed Description
OBJECTIVE: Compare the biomarkers of patients at high risk for ovarian cancer who are undergoing prophylactic oophorectomy and are interested in taking flutamide vs patients at high risk for ovarian cancer who are undergoing prophylactic oophorectomy and are not interested in taking flutamide (control) vs patients who are undergoing oophorectomy for a medical indication (control).
OUTLINE: Patients who elected not to receive flutamide received prophylactic oophorectomy or oophorectomy for a medical indication. Patients who elected to receive flutamide received 125mg once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent prophylactic oophorectomy. All patients underwent blood and ovarian tissue sample collection at the time of surgery for biomarker laboratory studies. Proteomic, microarray, and polymorphism analysis were performed on the blood and tissue samples.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 127
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Arm flutamide Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
- Primary Outcome Measures
Name Time Method Colony Stimulating Factor (CSF-1) Expression in Ovarian Stroma Surgery CSF-1 levels were measured by immunohistochemistry (IHC).
Colony Stimulating Factor (CSF-1) Expression in Ovarian Endosalpingiosis Surgery CSF-1 levels were measured by immunohistochemistry (IHC).
The modified H-Score assess extent of nuclear immunoreactivity applicable to steroid receptors.
The modified H-scores total range is 0-300. A lower modified H-score indicates weakly staining nuclei. A higher modified H-score indicated strongly staining nuclei.
This applies to all measures.Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Endosalpingiosis Surgery ErbB4 levels were measured by immunohistochemistry (IHC).
Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Epithelium Surgery ErbB4 levels were measured by immunohistochemistry (IHC).
Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Stroma Surgery ErbB4 levels were measured by immunohistochemistry (IHC).
Colony Stimulating Factor (CSF-1) Expression in Ovarian Epithelium Surgery CSF-1 levels were measured by immunohistochemistry (IHC).
Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Stroma Surgery CSF-1R levels were measured by immunohistochemistry (IHC).
Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Epithelium Surgery CSF-1R levels were measured by immunohistochemistry (IHC).
Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Endosalpingiosis Surgery CSF-1R levels were measured by immunohistochemistry (IHC).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States