Adnexal MassVOCALNCT03837327
Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy
An observational study of Adnexal Mass and Ovarian Cancer, run by Venn Biosciences Corporation at 26 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adnexal Mass, Ovarian Cancer, Pelvic Mass
- How many people
- 1,025 participants
- Where
- 26 sitesin 4 countries
- Study dates
- 16 Apr 2019to 22 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women who present with a known adnexal mass as described in the study inclusion and exclusion criteria.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
26 sites in 4 countries.
26 sites in 4 countries
Malaysia12 sites
Hospital Ampang
Ampang, Kuala Lumpur
Hospital Selayang
Batu Caves, Selangor
Hospital Raja Permaisuri Bainun
Ipoh, Perak
Hospital Sultan Ismail
Johor Bahru, Johor
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan
Hospital Wanita Dan Kanak-kanak Sabah
Kota Kinabalu, Sabah
Hospital Tengku Ampuan Afzan
Kuantan, Pahang
Hospital Umum Sarawak
Kuching, Sarawak
Hospital Miri
Miri, Sarawak
Hospital Seberang Jaya
Seberang Jaya, Pulau Pinang
Hospital Sibu
Sibu, Sarawak
Hospital Taiping
Taiping, Perak
United States10 sites
Optimum Clinical Research Group - Southwest Women's Oncology & Health
Albuquerque, New Mexico, 87109
Dr. Sudarshan K. Sharma, Ltd. - Gynecologic Oncology
Hinsdale, Illinois, 60521
Houston Methodist
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
University of Southern California
Los Angeles, California, 90033
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Bay Area Gynecology Oncology
San Jose, California, 95128
Memorial Health University Medical Center
Savannah, Georgia, 31404
Palo Alto Medical Foundation
Sunnyvale, California, 94086
University of South Florida USF Health, OB/Gyn
Tampa, Florida, 33612
Philippines3 sites
Philippine General Hospital
Manila
The Medical City
Pasig, National Capital Region, 1605
National Kidney and Transplant Institute
Quezon City, National Capital Region
About this study
Official title: Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy (VOCAL)
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.
Read the 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.
- Conditions
- Adnexal Mass, Ovarian Cancer, Pelvic Mass
- Keywords
- InterVenn, Ovarian Cancer, Liquid Biopsy, Mass Spectrometry, Adnexal Mass/ Pelvic Mass, Venn Biosciences, VOCAL Study
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adnexal Mass | Women with an adnexal mass (pelvic mass) as confirmed by imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test
Measured: 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
Measured: 24-48 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start16 Apr 2019
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adnexal MassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,025 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venn Biosciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Hommes, MD, Study chair, InterVenn Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837327
- Sponsor's protocol ID
- OVACA-001
- Acronym
- VOCAL
- Status last verified
- Aug 2023
- First submitted
- 8 Feb 2019
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy (VOCAL)
- ClinicalTrials.gov ID
- NCT03837327
- Acronym / sponsor ID
- VOCAL / OVACA-001
- Conditions
- Adnexal Mass, Ovarian Cancer, Pelvic Mass
- Keywords
- InterVenn, Ovarian Cancer, Liquid Biopsy, Mass Spectrometry, Adnexal Mass/ Pelvic Mass, Venn Biosciences, VOCAL Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,025 participants (actual)
- Lead sponsor
- Venn Biosciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adnexal Mass | – | –Women with an adnexal mass (pelvic mass) as confirmed by imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women who present with a known adnexal mass as described in the study inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test
Time frame: 24-48 Months
1 secondary outcome
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
Time frame: 24-48 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Hommes, MD study chair
InterVenn Biosciences
26 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adnexal Mass and Ovarian Cancer, run by Venn Biosciences Corporation at 26 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Malaysia, United States, Philippines, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test (time frame: 24-48 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.