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

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ClinicalTrials.gov Identifier: NCT03837327
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Venn Biosciences Corporation

Tracking Information
First Submitted Date February 8, 2019
First Posted Date February 12, 2019
Last Update Posted Date April 12, 2021
Actual Study Start Date April 16, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 8, 2019)
To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test [ Time Frame: 24-48 Months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 8, 2019)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy
Official Title Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy (VOCAL)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult women who present with a known adnexal mass as described in the study inclusion and exclusion criteria.
Condition
  • Adnexal Mass
  • Ovarian Cancer
  • Pelvic Mass
Intervention Not Provided
Study Groups/Cohorts Adnexal Mass
Women with an adnexal mass (pelvic mass) as confirmed by imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 8, 2019)
1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Per eligibility, individuals must have a known adnexal mass (pelvic mass).
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Klaus Lindpaintner, MD 1-888-706-1670 Klaus@venn.bio
Contact: Kaitlynn Moser 1-888-706-1670 kaitlynn@venn.bio
Listed Location Countries Australia,   Malaysia,   Philippines,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03837327
Other Study ID Numbers OVACA-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Venn Biosciences Corporation
Study Sponsor Venn Biosciences Corporation
Collaborators Not Provided
Investigators
Study Chair: Klaus Lindpaintner, MD Venn Biosciences Corporation
PRS Account Venn Biosciences Corporation
Verification Date April 2021