Actively Recruiting
A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass
Led by Cleo Diagnostics Ltd · Updated on 2025-02-04
1000
Participants Needed
8
Research Sites
99 weeks
Total Duration
On this page
Sponsors
C
Cleo Diagnostics Ltd
Lead Sponsor
L
Lindus Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Ovarian cancer is a serious health risk with the highest death rate among gynecological cancers. Unfortunately, it's only possible to definitively diagnose ovarian cancer after surgery, as there are no reliable tests to determine if an ovarian abnormality is cancerous or benign before surgery. Cleo Diagnostics have developed a new test that uses five biomarkers in the blood to better differentiate between benign and malignant ovarian conditions. In initial studies, this test outperformed the current standard test, CA125, in identifying cancer. This study aims to evaluate the effectiveness of the Cleo Diagnostics (CleoDX) Ovarian Adnexal Mass Score Test System. This test measures five analytes in the blood and provides a score indicating the likelihood of cancer in patients with an adnexal mass requiring surgery. The test is designed to assist doctors in making better-informed decisions about surgery and patient care by providing a more accurate pre-surgical assessment of cancer risk. By doing so, it aims to improve patient outcomes and ensure that those with malignant conditions receive the appropriate specialist care.
CONDITIONS
Official Title
A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients 18 years of age or older at the time of consent
- Able to provide written informed consent
- Have an ovarian cyst or adnexal mass identified by imaging (e.g., transvaginal ultrasound) that requires surgery and have not yet had the surgery
You will not qualify if you...
- Prior confirmed diagnosis or treatment for ovarian cancer
- Prior surgery removing both ovaries
- History of gynecological cancer within the last 2 years
- History of melanoma within the last 2 years
- Treatment with chemotherapy, radiotherapy, or immunotherapy within 12 months before sample collection
- Being immune-compromised due to conditions like HIV/AIDS, autoimmune disease, or recent immunosuppressive therapy
- Currently pregnant or pregnant within the last 3 months based on self-report
AI-Screening
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Trial Site Locations
Total: 8 locations
1
New Horizons Clinical Trials
Chandler, Arizona, United States, 85224
Actively Recruiting
2
Emerald Coast Clinical Research
Panama City, Florida, United States, 32405
Actively Recruiting
3
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89106
Actively Recruiting
4
The Jackson Clinic
Jackson, Tennessee, United States, 38305
Actively Recruiting
5
Next Innovative Clinical Research
Houston, Texas, United States, 77008
Actively Recruiting
6
Prime Clinical Research - Lewisville
Lewisville, Texas, United States, 75067
Actively Recruiting
7
Vast Clinical Research-Holy Cross
Mesquite, Texas, United States, 75149
Actively Recruiting
8
Virginia Women's Health Associates
Annandale, Virginia, United States, 22003
Actively Recruiting
Research Team
A
Assoc. Director of Operations Assoc. Director of Operations
CONTACT
T
Trial Coordinator
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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