Ovarian Cancer Clinical Trial
Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy
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.
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.
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)
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.
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.
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There are 12 Locations for this study
Los Angeles California, 90033, United States
San Jose California, 95128, United States
Sunnyvale California, 94086, United States
Jacksonville Florida, 32224, United States
Tampa Florida, 33612, United States
Savannah Georgia, 31404, United States
Hinsdale Illinois, 60521, United States
Omaha Nebraska, 68114, United States
Albuquerque New Mexico, 87109, United States
Houston Texas, 77030, United States
Parkville Victoria, 3052, Australia
Johor Bahru Johor, , Malaysia
Kota Bharu Kelantan, , Malaysia
Ampang Kuala Lumpur, , Malaysia
Kuantan Pahang, , Malaysia
Seberang Jaya Penang, , Malaysia
Ipoh Perak, , Malaysia
Taiping Perak, , Malaysia
Kota Kinabalu Sabah, , Malaysia
Kuching Sarawak, , Malaysia
Miri Sarawak, , Malaysia
Sibu Sarawak, , Malaysia
Batu Caves Selangor, , Malaysia
Pasig City Metro Manila, 1605, Philippines
Quezon City National Capital Region, , Philippines
Manila , , Philippines
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