Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy (VOCAL)
Trial ID: NCT03837327
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2019-04-16
Completion date: 2024-01-22
Sponsor: Venn Biosciences Corporation
Conditions: Adnexal Mass; Ovarian Cancer; Pelvic Mass
Locations: University of Southern California; Bay Area Gynecology Oncology; Palo Alto Medical Foundation; Mayo Clinic; University of South Florida USF Health, OB/Gyn; Memorial Health University Medical Center; Dr. Sudarshan K. Sharma, Ltd. - Gynecologic Oncology; Nebraska Methodist Hospital; Optimum Clinical Research Group - Southwest Women's Oncology & Health; Houston Methodist; Royal Women's Hospital; Hospital Sultan Ismail; Hospital Raja Perempuan Zainab II; Hospital Ampang; Hospital Tengku Ampuan Afzan; Hospital Raja Permaisuri Bainun; Hospital Taiping; Hospital Seberang Jaya; Hospital Wanita Dan Kanak-kanak Sabah; Hospital Umum Sarawak; Hospital Miri; Hospital Sibu; Hospital Selayang; The Medical City; National Kidney and Transplant Institute; Philippine General Hospital
Countries: United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; Australia; Malaysia; Malaysia; Malaysia; Malaysia; Malaysia; Malaysia; Malaysia; Malaysia; Malaysia; Malaysia; Malaysia; Malaysia; Philippines; Philippines; Philippines
Enrollment: 1025
Age range: 18 Years - None
Sex: FEMALE

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.

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.

Outcomes:
To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test