Ovarian Cancer Clinical Trial

Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 exclusion criteria as listed above.

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

1025

Study ID:

NCT03837327

Recruitment Status:

Completed

Sponsor:

Venn Biosciences Corporation

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There are 12 Locations for this study

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University of Southern California
Los Angeles California, 90033, United States
Bay Area Gynecology Oncology
San Jose California, 95128, United States
Palo Alto Medical Foundation
Sunnyvale California, 94086, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
University of South Florida USF Health, OB/Gyn
Tampa Florida, 33612, United States
Memorial Health University Medical Center
Savannah Georgia, 31404, United States
Dr. Sudarshan K. Sharma, Ltd. - Gynecologic Oncology
Hinsdale Illinois, 60521, United States
Nebraska Methodist Hospital
Omaha Nebraska, 68114, United States
Optimum Clinical Research Group - Southwest Women's Oncology & Health
Albuquerque New Mexico, 87109, United States
Houston Methodist
Houston Texas, 77030, United States
Royal Women's Hospital
Parkville Victoria, 3052, 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 Seberang Jaya
Seberang Jaya Penang, , Malaysia
Hospital Raja Permaisuri Bainun
Ipoh Perak, , Malaysia
Hospital Taiping
Taiping Perak, , 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 City Metro Manila, 1605, Philippines
National Kidney and Transplant Institute
Quezon City National Capital Region, , Philippines
Philippine General Hospital
Manila , , Philippines

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

1025

Study ID:

NCT03837327

Recruitment Status:

Completed

Sponsor:


Venn Biosciences Corporation

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