Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy

NCT03837327 | Completed

• 1 other identifier: OVACA-001
• Study Type: observational
• Target: 1,025
• Locations: 4 countries
• Sites: 26

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.

Conditions

Adnexal Mass; Ovarian Cancer; Pelvic Mass

Keywords

InterVenn; Ovarian Cancer; Liquid Biopsy; Mass Spectrometry; Adnexal Mass/ Pelvic Mass; Venn Biosciences; VOCAL Study

Outcome Measures

Primary Outcomes (1)

• To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test

  24-48 Months

Secondary Outcomes (1)

• 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

Study Arms (1)

Adnexal Mass

Women with an adnexal mass (pelvic mass) as confirmed by imaging

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Per eligibility, individuals must have a known adnexal mass (pelvic mass).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

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

Sponsors & Collaborators

• Venn Biosciences Corporation: lead

Study Sites (26)

University of Southern California

Los Angeles, California, 90033, United States

Location

Bay Area Gynecology Oncology

San Jose, California, 95128, United States

Location

Palo Alto Medical Foundation

Sunnyvale, California, 94086, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University of South Florida USF Health, OB/Gyn

Tampa, Florida, 33612, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Dr. Sudarshan K. Sharma, Ltd. - Gynecologic Oncology

Hinsdale, Illinois, 60521, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Optimum Clinical Research Group - Southwest Women's Oncology & Health

Albuquerque, New Mexico, 87109, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Royal Women's Hospital

Parkville, Victoria, 3052, Australia

Location

Hospital Sultan Ismail

Johor Bahru, Johor, Malaysia

Location

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, Malaysia

Location

Hospital Ampang

Ampang, Kuala Lumpur, Malaysia

Location

Hospital Tengku Ampuan Afzan

Kuantan, Pahang, Malaysia

Location

Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

Location

Hospital Taiping

Taiping, Perak, Malaysia

Location

Hospital Seberang Jaya

Seberang Jaya, Pulau Pinang, Malaysia

Location

Hospital Wanita Dan Kanak-kanak Sabah

Kota Kinabalu, Sabah, Malaysia

Location

Hospital Umum Sarawak

Kuching, Sarawak, Malaysia

Location

Hospital Miri

Miri, Sarawak, Malaysia

Location

Hospital Sibu

Sibu, Sarawak, Malaysia

Location

Hospital Selayang

Batu Caves, Selangor, Malaysia

Location

The Medical City

Pasig, National Capital Region, 1605, Philippines

Location

National Kidney and Transplant Institute

Quezon City, National Capital Region, Philippines

Location

Philippine General Hospital

Manila, Philippines

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Daniel Hommes, MD

  InterVenn Biosciences

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 12, 2019
• Study Start: April 16, 2019
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: April 23, 2024

Record last verified: 2023-08

Locations

US (10); PH (3); AU (1); MY (12)