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

Last updated: February 2, 2025
Sponsor: Cleo Diagnostics Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ovarian Cysts

Treatment

CleoDX ovarian cancer test

Clinical Study ID

NCT06566716
CSP-01-001
  • Ages > 18
  • Female

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 Criteria

Inclusion

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) thatrequires surgery, but have not yet undergone this surgery

Exclusion

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 themmore susceptible to infection, illness, or complications. These may include patientswith immune-suppressive conditions (e.g. HIV/AIDS), patients undergoing immuno-,chemo- or radio-therapy (within the last 12 months) for any reason, receiving immunesuppressive therapies (e.g. transplant recipients, individuals with known autoimmunedisease), or with a primary immunodeficiency disorder (e.g. Lupus).

  • Pregnant currently or within the last 3 months based on participant self-report

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: CleoDX ovarian cancer test
Phase:
Study Start date:
September 06, 2024
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • New Horizons Clinical Trials

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Zillan Clinical Research

    Inglewood, California 90303
    United States

    Site Not Available

  • GYN Research Institute

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Innovation Clinical Trials INC

    Palmetto Bay, Florida 33157
    United States

    Site Not Available

  • Emerald Coast Clinical Research

    Panama City, Florida 32405
    United States

    Active - Recruiting

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada 89106
    United States

    Active - Recruiting

  • ES Clinical Research Group LLC

    Fresh Meadows, New York 11365
    United States

    Site Not Available

  • The Jackson Clinic

    Jackson, Tennessee 38305
    United States

    Active - Recruiting

  • Next Innovative Clinical Research

    Houston, Texas 77008
    United States

    Active - Recruiting

  • Prime Clinical Research - Lewisville

    Lewisville, Texas 75067
    United States

    Active - Recruiting

  • Vast Clinical Research-Holy Cross

    Mesquite, Texas 75149
    United States

    Active - Recruiting

  • Virginia Women's Health Associates

    Annandale, Virginia 22003
    United States

    Active - Recruiting

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