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RECRUITINGOBSERVATIONAL

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

Validation of Ovarian Adnexal Mass Assessment Score Test System

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - female patients =\> 18 years of age at the time of consent - Can provide written willing to sign a consent form - 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 Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)), or with a primary weakened immune system disorder (e.g. Lupus). - Pregnant currently or within the last 3 months based on participant self-report Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

CleoDX ovarian cancer test

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

Locations (8)

New Horizons Clinical Trials
Chandler, Arizona, United States
Emerald Coast Clinical Research
Panama City, Florida, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
The Jackson Clinic
Jackson, Tennessee, United States
Next Innovative Clinical Research
Houston, Texas, United States
Prime Clinical Research - Lewisville
Lewisville, Texas, United States
Vast Clinical Research-Holy Cross
Mesquite, Texas, United States
Virginia Women's Health Associates
Annandale, Virginia, United States