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Validation of Ovarian Adnexal Mass Assessment Score Test System

  • Status
    Accepting Candidates
  • Age
    18 Years - 99 Years
  • Sexes
    Female
  • Healthy Volunteers
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Description

This study is designed to evaluate the clinical performance of CleoDX’s Ovarian Adnexal Mass Assessment Score Test System as a pre-surgical diagnostic aid for patients with adnexal masses. The goal of the test is to enhance pre-surgical workflows by aiding in the identification of potential malignancies and optimizing the clinical referral process. This study involves the collection of a single blood sample and post-surgical data. Blood samples will undergo testing for follicle-stimulating hormone (FSH) levels and the CleoDX Ovarian Adnexal Mass Score.

Details

Protocol number CSP-01-001

Eligibility

Inclusion Criteria

Participants must meet the following criteria to be eligible for participation:

  1. Are female patients ≥ 18 years of age at the time of consent
  2. Can provide written informed consent
  3. Have an ovarian cyst or adnexal mass identified through radiological imaging that requires surgery, but has not yet undergone this surgery

 

Exclusion Criteria

Participants will be excluded from the study if they meet any of the following criteria:

  1. Any prior confirmed diagnosis of, or treatment for, ovarian cancer
  2. Any prior surgery resulting in removal of both ovaries (bilateral oophorectomy)
  3. Prior history of gynecological malignancy (within last 2 years)
  4. Prior history of melanoma (within last 2 years). Prior treatment (within 12 months of sample collection) with chemotherapy, radiotherapy or immunotherapy
  5. Immune-compromised
  6. Pregnant currently or within the last 3 months based on participant-reported feedback. 


Lead researchers

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