Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy

Ovarian Cancer Clinical Trial

— VOCAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03837327
• Other study ID #: OVACA-001
• Status: Completed
• Start date: April 16, 2019
• Est. completion date: January 22, 2024

Study information

• Verified date: August 2023
• Source: Venn Biosciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1025
• Est. completion date: January 22, 2024
• Est. primary completion date: January 22, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adnexal Mass
• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Pelvic Mass

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Venn Biosciences Corporation

Countries where clinical trial is conducted

United States,  Australia,  Malaysia,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test		24-48 Months
Secondary	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