Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy
- Conditions
- Adnexal MassOvarian CancerPelvic Mass
- Registration Number
- NCT03837327
- Lead Sponsor
- Venn Biosciences Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1025
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test 24-48 Months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (26)
Bay Area Gynecology Oncology
🇺🇸San Jose, California, United States
University of South Florida USF Health, OB/Gyn
🇺🇸Tampa, Florida, United States
Dr. Sudarshan K. Sharma, Ltd. - Gynecologic Oncology
🇺🇸Hinsdale, Illinois, United States
Hospital Seberang Jaya
🇲🇾Seberang Jaya, Penang, Malaysia
Hospital Taiping
🇲🇾Taiping, Perak, Malaysia
Hospital Umum Sarawak
🇲🇾Kuching, Sarawak, Malaysia
Hospital Selayang
🇲🇾Batu Caves, Selangor, Malaysia
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Houston Methodist
🇺🇸Houston, Texas, United States
Hospital Tengku Ampuan Afzan
🇲🇾Kuantan, Pahang, Malaysia
Hospital Sultan Ismail
🇲🇾Johor Bahru, Johor, Malaysia
University of Southern California
🇺🇸Los Angeles, California, United States
Philippine General Hospital
🇵🇭Manila, Philippines
Hospital Ampang
🇲🇾Ampang, Kuala Lumpur, Malaysia
Palo Alto Medical Foundation
🇺🇸Sunnyvale, California, United States
Hospital Miri
🇲🇾Miri, Sarawak, Malaysia
Hospital Sibu
🇲🇾Sibu, Sarawak, Malaysia
Hospital Raja Permaisuri Bainun
🇲🇾Ipoh, Perak, Malaysia
The Medical City
🇵🇭Pasig City, Metro Manila, Philippines
National Kidney and Transplant Institute
🇵🇭Quezon City, National Capital Region, Philippines
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Optimum Clinical Research Group - Southwest Women's Oncology & Health
🇺🇸Albuquerque, New Mexico, United States
Hospital Wanita Dan Kanak-kanak Sabah
🇲🇾Kota Kinabalu, Sabah, Malaysia
Royal Women's Hospital
🇦🇺Parkville, Victoria, Australia
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Hospital Raja Perempuan Zainab II
🇲🇾Kota Bharu, Kelantan, Malaysia