Venn Biosciences Corporation ("InterVenn") has developed a liquid biopsy that is capable of distinguishing benign from malignant masses in women presenting with adnexal (pelvic) masses, through a simple blood test. The underlying technology combines mass spectrometry and artificial intelligence/machine learning to analyze tumor-associated changes in circulating glycoproteins. The purpose of this study is to prospectively collect de-identified biological samples and data from women with a known pelvic mass, in order to validate ovarian cancer specific glycoproteomic signatures in the blood based on histologically confirmed malignancy status of the mass.
This is a prospective, international, multi-center, observational study with a goal of collecting de-identified samples and data from 1,200 women with a known pelvic mass. Participants will consent to baseline and follow-up data and biospecimen collections.
Study Type
OBSERVATIONAL
Enrollment
1,025
University of Southern California
Los Angeles, California, United States
Bay Area Gynecology Oncology
San Jose, California, United States
Palo Alto Medical Foundation
Sunnyvale, California, United States
Mayo Clinic
Jacksonville, Florida, United States
University of South Florida USF Health, OB/Gyn
Tampa, Florida, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Dr. Sudarshan K. Sharma, Ltd. - Gynecologic Oncology
Hinsdale, Illinois, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Optimum Clinical Research Group - Southwest Women's Oncology & Health
Albuquerque, New Mexico, United States
Houston Methodist
Houston, Texas, United States
...and 16 more locations
To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test
Time frame: 24-48 Months
To evaluate the association of protein and glycoprotein (GP) biomarkers with histological subtypes, stage, treatments and disease free survival (DFS) among woman with ovarian cancer
Time frame: 24-48 Months
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