Clinical trial NCT03837327: Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy
Official title: Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy (VOCAL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adnexal Mass
Ovarian Cancer
Pelvic Mass
Keywords: InterVenn
Ovarian Cancer
Liquid Biopsy
Mass Spectrometry
Adnexal Mass/ Pelvic Mass
Venn Biosciences
VOCAL Study
Lead sponsor: Venn Biosciences Corporation
Sponsor class: INDUSTRY
First posted: 2019-02-12
Enrollment: 1025
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult women who present with a known adnexal mass as described in the study inclusion and exclusion criteria.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test
timeFrame: 24-48 Months
Secondary outcomes:
measure: 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
timeFrame: 24-48 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Jose
country: United States
facility: Bay Area Gynecology Oncology
state: California
city: Sunnyvale
country: United States
facility: Palo Alto Medical Foundation
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Tampa
country: United States
facility: University of South Florida USF Health, OB/Gyn
state: Florida
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Hinsdale
country: United States
facility: Dr. Sudarshan K. Sharma, Ltd. - Gynecologic Oncology
state: Illinois
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Albuquerque
country: United States
facility: Optimum Clinical Research Group - Southwest Women's Oncology & Health
state: New Mexico
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Parkville
country: Australia
facility: Royal Women's Hospital
state: Victoria
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail
state: Johor
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II
state: Kelantan
city: Ampang
country: Malaysia
facility: Hospital Ampang
state: Kuala Lumpur
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
state: Pahang
city: Seberang Jaya
country: Malaysia
facility: Hospital Seberang Jaya
state: Penang
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Perak
city: Taiping
country: Malaysia
facility: Hospital Taiping
state: Perak
city: Kota Kinabalu
country: Malaysia
facility: Hospital Wanita Dan Kanak-kanak Sabah
state: Sabah
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
state: Sarawak
city: Miri
country: Malaysia
facility: Hospital Miri
state: Sarawak
city: Sibu
country: Malaysia
facility: Hospital Sibu
state: Sarawak
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
state: Selangor
city: Pasig City
country: Philippines
facility: The Medical City
state: Metro Manila
city: Quezon City
country: Philippines
facility: National Kidney and Transplant Institute
state: National Capital Region
city: Manila
country: Philippines
facility: Philippine General Hospital
Study officials:
affiliation: InterVenn Biosciences
name: Daniel Hommes, MD
role: STUDY_CHAIR
References: