VOCAL: Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy

Sponsor

Venn Biosciences Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03837327

Collaborator

(none)

1,200

Enrollment

Locations

67.5

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adnexal Mass Ovarian Cancer Pelvic Mass

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 Design

Study Type:

Observational

Anticipated Enrollment :

1200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 16, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Adnexal Mass Women with an adnexal mass (pelvic mass) as confirmed by imaging

Outcome Measures

Primary Outcome Measures

To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test [24-48 Months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California	Los Angeles	California	United States	90033
2	Bay Area Gynecology Oncology	San Jose	California	United States	95128
3	Palo Alto Medical Foundation	Sunnyvale	California	United States	94086
4	Mayo Clinic	Jacksonville	Florida	United States	32224
5	Memorial Health University Medical Center	Savannah	Georgia	United States	31404
6	Dr. Sudarshan K. Sharma, Ltd. - Gynecologic Oncology	Hinsdale	Illinois	United States	60521
7	Nebraska Methodist Hospital	Omaha	Nebraska	United States	68114
8	Houston Methodist	Houston	Texas	United States	77030
9	Royal Women's Hospital	Parkville	Victoria	Australia	3052
10	Hospital Sultan Ismail	Johor Bahru	Johor	Malaysia
11	Hospital Raja Perempuan Zainab II	Kota Bharu	Kelantan	Malaysia
12	Hospital Ampang	Ampang	Kuala Lumpur	Malaysia
13	Hospital Tengku Ampuan Afzan	Kuantan	Pahang	Malaysia
14	Hospital Seberang Jaya	Seberang Jaya	Penang	Malaysia
15	Hospital Raja Permaisuri Bainun	Ipoh	Perak	Malaysia
16	Hospital Taiping	Taiping	Perak	Malaysia
17	Hospital Wanita Dan Kanak-kanak Sabah	Kota Kinabalu	Sabah	Malaysia
18	Hospital Umum Sarawak	Kuching	Sarawak	Malaysia
19	Hospital Miri	Miri	Sarawak	Malaysia
20	Hospital Sibu	Sibu	Sarawak	Malaysia
21	Hospital Selayang	Batu Caves	Selangor	Malaysia
22	The Medical City	Pasig City	Metro Manila	Philippines	1605
23	National Kidney and Transplant Institute	Quezon City	National Capital Region	Philippines
24	Philippine General Hospital	Manila		Philippines