- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03837327
Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy (VOCAL)
Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy (VOCAL)
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Klaus Lindpaintner, MD
- Phone Number: 1-888-706-1670
- Email: Klaus@venn.bio
Study Contact Backup
- Name: Kaitlynn Moser
- Phone Number: 1-888-706-1670
- Email: kaitlynn@venn.bio
Study Locations
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Victoria
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Parkville, Victoria, Australia, 3052
- Royal Women's Hospital
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Johor
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Johor Bahru, Johor, Malaysia
- Hospital Sultan Ismail
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Kelantan
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Kota Bharu, Kelantan, Malaysia
- Hospital Raja Perempuan Zainab II
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Kuala Lumpur
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Ampang, Kuala Lumpur, Malaysia
- Hospital Ampang
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Pahang
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Kuantan, Pahang, Malaysia
- Hospital Tengku Ampuan Afzan
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Penang
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Seberang Jaya, Penang, Malaysia
- Hospital Seberang Jaya
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Perak
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Ipoh, Perak, Malaysia
- Hospital Raja Permaisuri Bainun
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Taiping, Perak, Malaysia
- Hospital Taiping
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Sabah
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Kota Kinabalu, Sabah, Malaysia
- Hospital Wanita Dan Kanak-kanak Sabah
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Sarawak
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Kuching, Sarawak, Malaysia
- Hospital Umum Sarawak
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Miri, Sarawak, Malaysia
- Hospital Miri
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Sibu, Sarawak, Malaysia
- Hospital Sibu
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Selangor
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Batu Caves, Selangor, Malaysia
- Hospital Selayang
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Manila, Philippines
- Philippine General Hospital
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Metro Manila
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Pasig City, Metro Manila, Philippines, 1605
- The Medical City
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National Capital Region
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Quezon City, National Capital Region, Philippines
- National Kidney and Transplant Institute
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California
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Los Angeles, California, United States, 90033
- University of Southern California
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San Jose, California, United States, 95128
- Bay Area Gynecology Oncology
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Sunnyvale, California, United States, 94086
- Palo Alto Medical Foundation
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic
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Tampa, Florida, United States, 33612
- University of South Florida USF Health, OB/Gyn
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Georgia
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Savannah, Georgia, United States, 31404
- Memorial Health University Medical Center
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Illinois
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Hinsdale, Illinois, United States, 60521
- Dr. Sudarshan K. Sharma, Ltd. - Gynecologic Oncology
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Nebraska
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Omaha, Nebraska, United States, 68114
- Nebraska Methodist Hospital
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New Mexico
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Albuquerque, New Mexico, United States, 87109
- Optimum Clinical Research Group - Southwest Women's Oncology & Health
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Texas
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Houston, Texas, United States, 77030
- Houston Methodist
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Adnexal Mass
Women with an adnexal mass (pelvic mass) as confirmed by imaging
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test
Time Frame: 24-48 Months
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24-48 Months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
Time Frame: 24-48 Months
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24-48 Months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Daniel Hommes, MD, InterVenn Biosciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- OVACA-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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