Adnexal Mass, Ovarian Cancer, Pelvic Mass
Conditions
Keywords
InterVenn, Ovarian Cancer, Liquid Biopsy, Mass Spectrometry, Adnexal Mass/ Pelvic Mass, Venn Biosciences, VOCAL Study
Brief 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.
Interventions
None listed
Sponsors
Venn Biosciences Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test | 24-48 Months |
Secondary
| Measure | 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 |
Countries
Australia, Malaysia, Philippines, United States
Outcome results
None listed