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Trial record 1 of 1 for:    NCT03837327
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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 : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Venn Biosciences Corporation

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.


Condition or disease
Adnexal Mass Ovarian Cancer Pelvic 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.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy (VOCAL)
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021


Group/Cohort
Adnexal Mass
Women with an adnexal mass (pelvic mass) as confirmed by imaging



Primary Outcome Measures :
  1. To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test [ Time Frame: 24-48 Months ]

Secondary Outcome Measures :
  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 [ Time Frame: 24-48 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Per eligibility, individuals must have a known adnexal mass (pelvic mass).
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult women who present with a known adnexal mass as described in the study inclusion and exclusion criteria.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837327


Contacts
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Contact: Ling Shen, Ph.D. 1-888-706-1670 ling@venn.bio
Contact: Kaitlynn Moser 1-888-706-1670 kaitlynn@venn.bio

Locations
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Malaysia
Hospital Sultan Ismail Recruiting
Johor Bahru, Johor, Malaysia
Contact: Rathi Raja    +07-3565155    rathi@clinicalresearch.my   
Contact: Adnin Adawiyah    +607-3565155    adnin.adawiyah@clinicalresearch.my   
Principal Investigator: Nor Hidayah Binti Yayanto, MD         
Hospital Seberang Jaya Recruiting
Seberang Jaya, Penang, Malaysia
Contact: Francis, Bee Ai Ooi    +604-3827222 ext 346/ 618    francis@clinicalresearch.my   
Principal Investigator: Salina Bt Sany, MD         
Hospital Raja Permaisuri Bainun Recruiting
Ipoh, Perak, Malaysia
Contact: Sivanesan Seevagan    +60105682316    sivanesan@clinicalresearch.my   
Principal Investigator: Lee Saw Joo, MD         
Philippines
The Medical City Recruiting
Pasig City, Metro Manila, Philippines, 1605
Contact: Maria Regina Budac    639178916519 ext 639178916519    mbudac@venn.bio   
Contact: Axel Kornerup    639178916519 ext 639178916519    axel@venn.bio   
Principal Investigator: Beatrice Tiangco, MD         
Sponsors and Collaborators
Venn Biosciences Corporation
Investigators
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Study Chair: Ling Shen, Ph.D Venn Biosciences Corporation

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Responsible Party: Venn Biosciences Corporation
ClinicalTrials.gov Identifier: NCT03837327     History of Changes
Other Study ID Numbers: OVACA-001
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Venn Biosciences Corporation:
InterVenn
Ovarian Cancer
Liquid Biopsy
Mass Spectrometry
Adnexal Mass/ Pelvic Mass
Venn Biosciences
VOCAL Study

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type