Non-Treatment Study for Patients with Ovarian Cancer

This non-treatment study is enrolling participants identified with an adnexal mass (lump in the uterus, usually in the ovary or fallopian tube) that requires surgery. The study is testing the CleoDX ovarian adnexal mass assessment score test system, which measures five substances in blood and combines their values into a single score. This score indicates how likely it is that the mass is malignant (cancerous) before surgery.

The study aims to:

• Obtain the CleoDx adnexal mass score in patients identified with an adnexal mass requiring surgery
• Evaluate the performance of the scoring system
• Find out if the CleoDX adnexal mass scoring system is more effective than current clinical workflows at predicting if a mass is cancerous or non-cancerous

This study involves a single blood draw (one 8 milliliter tube) to obtain a sample for the CleoDX adnexal mass scoring system and collecting some of the participant's medical record information. This scoring system has not yet been approved by the US Food and Drug Administration (FDA) as a method of identifying malignancy. Subjects will not receive the results of this scoring system.

In order to participate you must meet the following criteria:

• Are a female ≥ 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 radiological imaging that requires surgery, but has not yet undergone this surgery.

You will be excluded from the study if any of the following criteria apply to you:

• Have any prior confirmed diagnosis of, or treatment for, ovarian cancer.
• Have any prior surgery resulting in removal of both ovaries (bilateral oophorectomy).
• Have prior history of gynecological malignancy (within last 2 years).
• Have prior history of melanoma (within last 2 years).
• Have prior treatment (within 12 months of sample collection) with chemotherapy, radiotherapy or immunotherapy.
• Are 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).

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.