Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy (VOCAL)
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| ClinicalTrials.gov Identifier: NCT03837327 |
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Recruitment Status :
Recruiting
First Posted : February 12, 2019
Last Update Posted : June 28, 2022
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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 |
| 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 : | December 2022 |
| Estimated Study Completion Date : | December 2024 |
| Group/Cohort |
|---|
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Adnexal Mass
Women with an adnexal mass (pelvic mass) as confirmed by imaging
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- To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test [ Time Frame: 24-48 Months ]
- 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 ]
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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 |
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.
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
| Contact: Klaus Lindpaintner, MD | 1-888-706-1670 | Klaus@venn.bio | |
| Contact: Kaitlynn Moser | 1-888-706-1670 | kaitlynn@venn.bio |
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| Study Chair: | Klaus Lindpaintner, MD | Venn Biosciences Corporation |
| Responsible Party: | Venn Biosciences Corporation |
| ClinicalTrials.gov Identifier: | NCT03837327 |
| Other Study ID Numbers: |
OVACA-001 |
| First Posted: | February 12, 2019 Key Record Dates |
| Last Update Posted: | June 28, 2022 |
| Last Verified: | June 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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InterVenn Ovarian Cancer Liquid Biopsy Mass Spectrometry |
Adnexal Mass/ Pelvic Mass Venn Biosciences VOCAL Study |
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Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Ovarian Epithelial Ovarian Diseases |
Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Endocrine System Diseases Gonadal Disorders Carcinoma |