A Novel Predictive Multi-Marker Test for the Pre-Surgical Identification of Ovarian Cancer.
Andrew N Stephens, Simon J Hobbs, Sung-Woon Kang...
https://pubmed.ncbi.nlm.nih.gov/37958440Actively Recruiting
Age: 18Years +
FEMALE
ID06566716
Validation of CleoDX Ovarian Adnexal Mass Assessment Score Test System to Evaluate Cancer Risk Before Surgery
Led by Cleo Diagnostics Ltd · Updated on 2025-02-04
1000
Participants Needed
8
Research Sites
52 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 concern with the highest death rate among gynecological cancers. Diagnosing ovarian cancer definitively requires surgery since current tests cannot reliably distinguish between benign and malignant ovarian abnormalities before surgery. Researchers are evaluating the Cleo Diagnostics (CleoDX) Ovarian Adnexal Mass Score Test System, which measures five blood biomarkers to better assess the likelihood of cancer in patients with ovarian masses needing surgery. This test aims to help doctors make more informed decisions about surgery and patient care by providing a more accurate pre-surgical cancer risk assessment. The study involves patients with ovarian cysts or adnexal masses identified by imaging who require surgery but have not yet undergone it. The CleoDX test analyzes blood samples to generate a score indicating cancer risk, and patients are categorized after surgery as having malignant or benign masses. The study compares the CleoDX test results to standard clinical assessments and post-surgical pathology to evaluate the test's accuracy and performance. Participants will provide blood samples before surgery, and their clinical and pathological information will be collected and analyzed. The primary outcome is the calculation of the CleoDX adnexal mass score, with secondary outcomes comparing the test's score to clinical and pathological findings. Data analysis will take place after patient recruitment, continuing for up to 12 months or until the study ends in August 2026. The study involves monitoring and evaluating the test's ability to predict cancer risk accurately before surgery.
CONDITIONS
Brief Title
A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older at the time of consent
- Able to provide written informed consent
- Have an ovarian cyst or adnexal mass (simple, complex, or solid ovarian/pelvic mass) identified by imaging requiring surgery, but surgery has not yet been performed
You will not qualify if you...
- Prior confirmed diagnosis or treatment for ovarian cancer
- Prior surgery removing both ovaries
- History of gynecological malignancy 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
- Immune-compromised conditions including HIV/AIDS, recent immuno-, chemo-, or radio-therapy, immune suppressive therapies, autoimmune diseases, or primary immunodeficiency disorders
- Currently pregnant or pregnant within the last 3 months based on self-report
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to the time of surgery
Participants undergo the CleoDX ovarian cancer test to assist in predicting risk of malignancy prior to surgery for an adnexal mass.
1 visit before surgery
Long-term Monitoring
Duration - Up to 12 months after surgery or until study completion
Participants are observed through surgical diagnosis and follow-up to compare CleoDX test results with post-surgical pathology and clinical information.
Follow-up visits as part of routine care
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
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Research Team
A
Assoc. Director of Operations Assoc. Director of Operations
T
Trial Coordinator
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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Published Research Related To This Trial
Utility of a Multi-Marker Panel with Ultrasound for Enhanced Classification of Adnexal Mass.
Andrew N Stephens, Simon J Hobbs, Sung-Woog Kang...
https://pubmed.ncbi.nlm.nih.gov/38893167ReClassification of Patients with Ambiguous CA125 for Optimised Pre-Surgical Triage.
Andrew N Stephens, Simon J Hobbs, Sung-Woog Kang...
https://pubmed.ncbi.nlm.nih.gov/38611584