Status:
COMPLETED
Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy
Lead Sponsor:
Venn Biosciences Corporation
Conditions:
Adnexal Mass
Ovarian Cancer
Eligibility:
FEMALE
18+ years
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 simp...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 22 2024
Estimated Enrollment :
1025 Patients enrolled
Trial Details
Trial ID
NCT03837327
Start Date
April 16 2019
End Date
January 22 2024
Last Update
April 23 2024
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Southern California
Los Angeles, California, United States, 90033
2
Bay Area Gynecology Oncology
San Jose, California, United States, 95128
3
Palo Alto Medical Foundation
Sunnyvale, California, United States, 94086
4
Mayo Clinic
Jacksonville, Florida, United States, 32224