Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy (VOCAL)

April 22, 2024 updated by: Venn Biosciences Corporation

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

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1025

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Royal Women's Hospital
  • Malaysia
    • Johor
      • Johor Bahru, Johor, Malaysia
        • Hospital Sultan Ismail
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia
        • Hospital Raja Perempuan Zainab II
    • Kuala Lumpur
      • Ampang, Kuala Lumpur, Malaysia
        • Hospital Ampang
    • Pahang
      • Kuantan, Pahang, Malaysia
        • Hospital Tengku Ampuan Afzan
    • Penang
      • Seberang Jaya, Penang, Malaysia
        • Hospital Seberang Jaya
    • Perak
      • Ipoh, Perak, Malaysia
        • Hospital Raja Permaisuri Bainun
      • Taiping, Perak, Malaysia
        • Hospital Taiping
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia
        • Hospital Wanita Dan Kanak-Kanak Sabah
    • Sarawak
      • Kuching, Sarawak, Malaysia
        • Hospital Umum Sarawak
      • Miri, Sarawak, Malaysia
        • Hospital Miri
      • Sibu, Sarawak, Malaysia
        • Hospital Sibu
    • Selangor
      • Batu Caves, Selangor, Malaysia
        • Hospital Selayang
  • Philippines
      • Manila, Philippines
        • Philippine General Hospital
    • Metro Manila
      • Pasig City, Metro Manila, Philippines, 1605
        • The Medical City
    • National Capital Region
      • Quezon City, National Capital Region, Philippines
        • National Kidney and Transplant Institute
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • San Jose, California, United States, 95128
        • Bay Area Gynecology Oncology
      • Sunnyvale, California, United States, 94086
        • Palo Alto Medical Foundation
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Tampa, Florida, United States, 33612
        • University of South Florida USF Health, OB/Gyn
    • Georgia
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Dr. Sudarshan K. Sharma, Ltd. - Gynecologic Oncology
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Optimum Clinical Research Group - Southwest Women's Oncology & Health
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult women who present with a known adnexal mass as described in the study inclusion and exclusion criteria.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Adnexal Mass
Women with an adnexal mass (pelvic mass) as confirmed by imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test
Time Frame: 24-48 Months
24-48 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24-48 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Venn Biosciences Corporation

Investigators

  • Study Chair: Daniel Hommes, MD, InterVenn Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2019

Primary Completion (Actual)

January 22, 2024

Study Completion (Actual)

January 22, 2024

Study Registration Dates

First Submitted

February 8, 2019

First Submitted That Met QC Criteria

February 8, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OVACA-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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