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

Not Applicable

Not yet recruiting

Conditions: Cancer - Ovarian and primary peritoneal
ovarian cancer
adnexal mass
benign ovarian mass
Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

Registration Number: ACTRN12624000882527

Lead Sponsor: Cleo Diagnostics Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not yet recruiting

Sex: Female

Target Recruitment: 500

Inclusion Criteria

1. 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 (simple, complex, or solid ovarian/pelvic mass) identified through imaging examination (transvaginal ultrasound - TVU) that requires surgery, but have not yet undergone surgery

Exclusion Criteria

1.Pregnant currently / within the last 3 months
2.Current or previous ovarian cancer
3.Prior bilateral oophorectomy or otherwise in surgical menopause
4.Diagnosed with any gynecological malignancy within last 2 years
5.Diagnosed with melanoma within last 2 years
6.Current or prior (previous 12 months) treatment with chemotherapy, radiotherapy or immunotherapy
7.Immune-compromised – defined as 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).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Calculation of a CleoDX Pre-Surgical Triage Test malignancy risk score[ CleoDX Pre-Surgical Triage Test malignancy risk score from serum assay (drawn pre-surgically) Scores will be determined retrospectively on completion of study enrollment (anticipated maximum 1 year following surgery).]

Secondary Outcome Measures