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Clinical Trials in the USA / NCT06566716
Active, not recruiting Observational

A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women With an Ovarian Mass

NCT06566716 · tracked via the Priya Life Science USA tracker
Sponsor
Cleo Diagnostics Ltd
Phase
Observational
Started
2024-09-06
Last updated
2026-10-27

Condition(s) studied

Ovarian Neoplasms

Investigational drug(s) / intervention(s)

CleoDX ovarian cancer test

CleoDX ovarian cancer test: A diagnostic test to assist in predicting risk of malignancy prior to surgery for patients with an adnexal mass.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * female patients =\> 18 years of age at the time of consent * Can provide written informed consent * Have an ovarian cyst or adnexal mass (simple, complex, or solid ovarian/pelvic mass) identified through imaging examination (e.g. transvaginal ultrasound - TVU) that requires surgery, but have not yet undergone this surgery Exclusion Criteria: * Any prior confirmed diagnosis of, or treatment for, ovarian cancer * Any prior surgery resulting in removal of both ovaries * Prior history of gynecological malignancy (within last 2 years) * Prior history of melanoma (within last 2 years) * Prior treatment (within 12 months of sample collection) with chemotherapy, radiotherapy or immunotherapy * Immune-compromised. Definition: those whose weakened immune system may render them more susceptible to infection, illness, or complications. These may include patients with immune-suppressive conditions (e.g. HIV/AIDS), patients undergoing immuno-, chemo- or radio-therapy (within the last 12 months) for any reason, receiving immune suppressive therapies (e.g. transplant recipients, individuals with known autoimmune disease), or with a primary immunodeficiency disorder (e.g. Lupus). * Pregnant currently or within the last 3 months based on participant self-report

Primary outcome measure(s)

  • Calculation of the CleoDX adnexal mass score — Outcomes will be assessed during an analysis phase, which will commence after completion of patient recruitment and continue for up to 12 months or the end of the study period is reached (August 2026), whichever occurs first.
    Determine the Cleo Diagnostics (CleoDX) adnexal mass score in patients identified with an adnexal mass requiring surgery, but who have not yet undergone this surgery.

Trial sites (19)

FacilityCityRegionStatus
New Horizons Clinical Trials Chandler Arizona
University of Florida - Jacksonville Jacksonville Florida
HCA Florida Physicians Miami Florida
Velocity Clinical Research - Annapolis Miami Florida
Emerald Coast Clinical Research Panama City Florida
Springfield Clinic Springfield Illinois
Dana-Farber Beth Israel Deaconess Medical Center Boston Massachusetts
Women's Cancer Center of Nevada Las Vegas Nevada
Women's Health Pavilion Howard Beach New York
Columbia University Irving Medical Center New York New York
Rush University Medical Centre Poughkeepsie New York
Duke University Medical Centre Durham North Carolina
Cleveland Clinic Cleveland Ohio
The Jackson Clinic Jackson Tennessee
Next Innovative Clinical Research Houston Texas
Maximos Ob/Gyn League City Texas
Prime Clinical Research - Lewisville Lewisville Texas
Vast Clinical Research-Holy Cross Mesquite Texas
Virginia Women's Health Associates Annandale Virginia

Other trials for the same condition

Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C) Active, not recruiting
A Study of Sofe-M in Participants With Selected Advanced Solid Tumors Recruiting
A Study of DM002 in Patients With Advanced Solid Tumors Recruiting
A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) Recruiting
Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06566716 on ClinicalTrials.gov ↗ ← All trials in the USA