NCT03837327

Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy

Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy (VOCAL)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,025 (actual)
• Sponsor: Venn Biosciences Corporation · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adnexal Mass
• Ovarian Cancer
• Pelvic Mass

Timeline

• Start date: 2019-04-16
• Primary completion: 2024-01-22
• Completion: 2024-01-22
• First posted: 2019-02-12
• Last updated: 2024-04-23

Locations

26 sites across 4 countries: United States, Australia, Malaysia, Philippines