Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adnexal Mass, Ovarian Cancer, Pelvic Mass

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women age 18 years or older Able to provide a written informed consent and who understand and agree to all study procedures required A newly diagnosed adnexal mass as confirmed by imaging (computed tomography, ultrasonography, or magnetic resonance imaging) prior to enrollment Planned diagnostic procedure or surgery by the subject's physician to remove adnexal masses within 90 days of imaging. (Note that diagnostic procedure typically includes biopsy (needle core or laparoscopic-directed), ascites cytology, pleural effusion cytology or FNA) Exclusion Criteria: Had/Has a diagnosis of invasive malignancy (exception: non-melanoma skin cancers) in the previous 5 years. Currently receiving or ever received any of the following prior cancer therapies in the previous 5 years. This includes curative surgical resection, local or systemic chemotherapy, targeted therapy, immunotherapy including cancer vaccines, hormone therapy, and/or radiation therapy. Pregnancy Current febrile illness Acute exacerbation or flare of an inflammatory condition requiring escalation in therapy Recipient of organ transplant Poor health status or unfit to tolerate blood draw In addition, this study will include a small subgroup of women with a newly diagnosed clinically benign adnexal mass(es) for whom surgery is not planned as determined by the treating physician. This subgroup will follow the same exclusion criteria as listed above.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adnexal Mass<br>Women with an adnexal mass (pelvic mass) as confirmed by imaging | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test |  | 24-48 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 24-48 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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InterVenn, Ovarian Cancer, Liquid Biopsy, Mass Spectrometry, Adnexal Mass/ Pelvic Mass, Venn Biosciences, VOCAL Study