Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy

Prior treatment

• Had/Has a diagnosis of invasive malignancy (exception: non-melanoma skin cancers) in the previous 5 years.
• 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.

Other illness

• 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.
• Current febrile illness
• Acute exacerbation or flare of an inflammatory condition requiring escalation in therapy

Other

• Pregnancy

• 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)