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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adnexal Mass | Women with an adnexal mass (pelvic mass) as confirmed by imaging |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test | 24-48 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24-48 Months |
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Inclusion Criteria:
Exclusion Criteria:
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.
Per eligibility, individuals must have a known adnexal mass (pelvic mass).
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Adult women who present with a known adnexal mass as described in the study inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Hommes, MD | InterVenn Biosciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Bay Area Gynecology Oncology |
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| San Jose |
| California |
| 95128 |
| United States |
| Palo Alto Medical Foundation | Sunnyvale | California | 94086 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| University of South Florida USF Health, OB/Gyn | Tampa | Florida | 33612 | United States |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | United States |
| Dr. Sudarshan K. Sharma, Ltd. - Gynecologic Oncology | Hinsdale | Illinois | 60521 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Optimum Clinical Research Group - Southwest Women's Oncology & Health | Albuquerque | New Mexico | 87109 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| Royal Women's Hospital | Parkville | Victoria | 3052 | Australia |
| Hospital Sultan Ismail | Johor Bahru | Johor | Malaysia |
| Hospital Raja Perempuan Zainab II | Kota Bharu | Kelantan | Malaysia |
| Hospital Ampang | Ampang | Kuala Lumpur | Malaysia |
| Hospital Tengku Ampuan Afzan | Kuantan | Pahang | Malaysia |
| Hospital Raja Permaisuri Bainun | Ipoh | Perak | Malaysia |
| Hospital Taiping | Taiping | Perak | Malaysia |
| Hospital Seberang Jaya | Seberang Jaya | Pulau Pinang | Malaysia |
| Hospital Wanita Dan Kanak-kanak Sabah | Kota Kinabalu | Sabah | Malaysia |
| Hospital Umum Sarawak | Kuching | Sarawak | Malaysia |
| Hospital Miri | Miri | Sarawak | Malaysia |
| Hospital Sibu | Sibu | Sarawak | Malaysia |
| Hospital Selayang | Batu Caves | Selangor | Malaysia |
| The Medical City | Pasig | National Capital Region | 1605 | Philippines |
| National Kidney and Transplant Institute | Quezon City | National Capital Region | Philippines |
| Philippine General Hospital | Manila | Philippines |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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