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Submitted by: Ramonito Nuique 2020-02-12 01:53:14 Last Updated by: Principe, Jeverly Ann S 2020-02-12 10:27:03


VOCAL Study

PHRR200212-002499

Validation of the Venn Ovarian CAncer Liquid Biopsy: VOCAL Study

Sponsor
Protocol Title Protocol Number Study design

PROTOCOL SYNOPSIS

Venn Biosciences Corporation
800 Chesapeake Drive, Redwood City, CA 94063

Clinical Validation of the Venn Ovarian CAncer Liquid Biopsy: VOCAL Study OVACA-001
This is a prospective, international multi-center, observational study

Primary Objectives

The primary objective of this study is to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the Venn Ovarian Cancer Liquid Biopsy among women with ovarian adnexal mass for which a surgery is planned. Tumor primary site and malignancy will be confirmed by histopathologic examination.

Secondary Objective

The secondary objective of this study is to evaluate the association of proteins and Glycoproteins (GPs) biomarkers with histological subtypes, stage, treatments and disease free survival (DFS) among ovarian cancer patients.

Sites

This clinical validation study will be performed at approximately 5 sites in US, 15 sites in Malaysia and 3 sites in Philippines.

At Sponsor’s discretion, this study may be expanded to other countries.

Study Population

Women at least 18 years of age, who present ovarian adnexal mass for which a diagnostic procedure or surgery is planned. Subjects are considered enrolled after understanding and signing the ICF and a determination is made by the Investigator or the study coordinator that the subject is eligible to participate according to the inclusion/exclusion criteria and subject has completed the questionnaire. Enrollment will be stopped when a sufficient number of confirmed cases of ovarian cancer have been diagnosed among the study population. Additionally, we will enroll a control group of about 10-15 % of the total study population with newly diagnosed clinically benign adnexal masses for whom no intervention surgery is planned.

Under the current assumptions, up to 600 participants will need to be enrolled from US sites and up to 600 from Malaysia and Philippines.

Start Date Duration in Months Target Completion Date Actual Completion Date
2019-02-08 60 2024-02-08 0000-00-00

Ongoing

Institution Classification Region LTO #
Intervenn Biosciences, Inc. Private Business United States of America
Institution Classification Region LTO #
University of the Philippines - Philippine General Hospital Government NCR
Institution Region
INTERVENN BIOSCIENCES, INC. United States of America
Name E-Mail Institution and Institution Address
Ramonito Nuique rnuique@venn.bio CRU 3, Medical Research Laboratory, UP-PGH, Taft Ave., Manila
Name E-Mail Institution and Institution Address
Beatrice Tiangco bjtiangco@up.edu.ph CRU 3, Medical Research Laboratory, UP-PGH, Taft Ave., Manila
Name Expertise Affiliation
Beatrice J. Tiangco, MD Hematology-Oncology National Institutes of Health - University of the Philippines - Manila

Adnexal Masses, both benign and malignant

to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the Venn Ovarian Cancer Liquid Biopsy among women with ovarian adnexal mass for which a surgery is planned. Tumor primary site and malignancy will be confirmed by histopathologic examination.

to evaluate the association of proteins and Glycoproteins (GPs) biomarkers with histological subtypes, stage, treatments and disease free survival (DFS) among ovarian cancer patients.

Pending

  • Malaysia
  • Philippines
  • United States

Non-clinical Studies

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