Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy (VOCAL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03837327|
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : June 28, 2022
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.
|Condition or disease|
|Adnexal Mass Ovarian Cancer Pelvic Mass|
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy (VOCAL)|
|Actual Study Start Date :||April 16, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2024|
Women with an adnexal mass (pelvic mass) as confirmed by imaging
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837327
|Contact: Klaus Lindpaintner, MD||1-888-706-1670||Klaus@venn.bio|
|Contact: Kaitlynn Moseremail@example.com|
|Study Chair:||Klaus Lindpaintner, MD||Venn Biosciences Corporation|