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

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Cleo Diagnostics Ltd
Study ID
NCT06566716
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 6, 2024
Status verified
Aug 2024
Primary completion
Aug 31, 2025
Completion
Aug 31, 2026

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Malignant
    Patients with an adnexal mass that is surgically diagnosed as malignant
  • Arm: Non-Malignant
    Patients with an adnexal mass that is surgically diagnosed as benign

Primary Outcome Measure

Calculation of the CleoDX adnexal mass score [ Time Frame: 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. ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
New Horizons Clinical TrialsChandlerArizona85224
Monte Swarup, MD
[email protected]
480 496-2236
Emerald Coast Clinical ResearchPanama CityFlorida32405
Samuel Wolf, DO
[email protected]
850-250-0194
Women's Cancer Center of NevadaLas VegasNevada89106
Nicola M Spirtos
[email protected]
702 851 4672
The Jackson ClinicJacksonTennessee38305
Daniel Fleming, DO
[email protected]
731-660-8396
Next Innovative Clinical ResearchHoustonTexas77008
Arturo Sandoval, MD
[email protected]
312-761-4244
Prime Clinical Research - LewisvilleLewisvilleTexas75067
Munira Dudhbhai
[email protected]
817-907-7330
Vast Clinical Research-Holy CrossMesquiteTexas75149
Maduka Odogwu, MD
[email protected]
469 862 3756
Virginia Women's Health AssociatesAnnandaleVirginia22003
Camilla Hersh, MD
[email protected]
888-407-9881

Find similar trials in Chandler, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
New Horizons Clinical Trials· Chandler, AZEmerald Coast Clinical Research· Panama City, FLWomen's Cancer Center of Nevada· Las Vegas, NVThe Jackson Clinic· Jackson, TNNext Innovative Clinical Research· Houston, TXPrime Clinical Research - Lewisville· Lewisville, TX

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