Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy

Completed

Conditions studied: Adnexal Mass, Ovarian Cancer, Pelvic Mass

In brief

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.

Key facts

Study ID

NCT03837327

Run by

Venn Biosciences Corporation

People needed

1025

Starts

2019-04-16

Expected to finish

2024-01-22

Last updated by the study team

2024-04-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• University of Southern California — Los Angeles, California, United States
• Bay Area Gynecology Oncology — San Jose, California, United States
• Palo Alto Medical Foundation — Sunnyvale, California, United States
• Mayo Clinic — Jacksonville, Florida, United States
• University of South Florida USF Health, OB/Gyn — Tampa, Florida, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• Dr. Sudarshan K. Sharma, Ltd. - Gynecologic Oncology — Hinsdale, Illinois, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• Optimum Clinical Research Group - Southwest Women's Oncology & Health — Albuquerque, New Mexico, United States
• Houston Methodist — Houston, Texas, United States
• Royal Women's Hospital — Parkville, Victoria, Australia
• Hospital Sultan Ismail — Johor Bahru, Johor, Malaysia
• Hospital Raja Perempuan Zainab II — Kota Bharu, Kelantan, Malaysia
• Hospital Ampang — Ampang, Kuala Lumpur, Malaysia
• Hospital Tengku Ampuan Afzan — Kuantan, Pahang, Malaysia
• Hospital Raja Permaisuri Bainun — Ipoh, Perak, Malaysia
• Hospital Taiping — Taiping, Perak, Malaysia
• Hospital Seberang Jaya — Seberang Jaya, Pulau Pinang, Malaysia
• Hospital Wanita Dan Kanak-kanak Sabah — Kota Kinabalu, Sabah, Malaysia
• Hospital Umum Sarawak — Kuching, Sarawak, Malaysia
• Hospital Miri — Miri, Sarawak, Malaysia
• Hospital Sibu — Sibu, Sarawak, Malaysia
• Hospital Selayang — Batu Caves, Selangor, Malaysia
• The Medical City — Pasig, National Capital Region, Philippines
• National Kidney and Transplant Institute — Quezon City, National Capital Region, Philippines

Full record on ClinicalTrials.gov

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