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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03837327




Registration number
NCT03837327
Ethics application status
Date submitted
8/02/2019
Date registered
12/02/2019
Date last updated
23/04/2024

Titles & IDs
Public title
Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy
Scientific title
Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy (VOCAL)
Secondary ID [1] 0 0
OVACA-001
Universal Trial Number (UTN)
Trial acronym
VOCAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adnexal Mass 0 0
Ovarian Cancer 0 0
Pelvic Mass 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Adnexal Mass - Women with an adnexal mass (pelvic mass) as confirmed by imaging
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test
Timepoint [1] 0 0
24-48 Months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
24-48 Months

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/01/2024
Sample size
Target
Accrual to date
Final
1025
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
New Mexico
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Malaysia
State/province [8] 0 0
Johor
Country [9] 0 0
Malaysia
State/province [9] 0 0
Kelantan
Country [10] 0 0
Malaysia
State/province [10] 0 0
Kuala Lumpur
Country [11] 0 0
Malaysia
State/province [11] 0 0
Pahang
Country [12] 0 0
Malaysia
State/province [12] 0 0
Penang
Country [13] 0 0
Malaysia
State/province [13] 0 0
Perak
Country [14] 0 0
Malaysia
State/province [14] 0 0
Sabah
Country [15] 0 0
Malaysia
State/province [15] 0 0
Sarawak
Country [16] 0 0
Malaysia
State/province [16] 0 0
Selangor
Country [17] 0 0
Philippines
State/province [17] 0 0
Metro Manila
Country [18] 0 0
Philippines
State/province [18] 0 0
National Capital Region
Country [19] 0 0
Philippines
State/province [19] 0 0
Manila

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Venn Biosciences Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03837327
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Hommes, MD
Address 0 0
InterVenn Biosciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03837327