None listed
Conditions
Brief summary
This study will evaluate a diagnostic test for cancer risk before surgery women with an ovarian mass Who is it for? You may be eligible to join this study if you are aged 18 years and above and have an ovarian cyst or adnexal mass (simple, complex, or solid ovarian/pelvic mass) identified through imaging examination that requires surgery. You will already have had a CA125 test and a transvaginal ultrasound, and your doctor will have made a decision to send you to a specialist for further examination. Study details Cleo Diagnostics Ltd has developed a novel Ovarian Cancer Adnexal Mass Assessment Score test system. Participants in this study will have a single blood sample taken prior to surgery for testing using the novel Ovarian Cancer Adnexal Mass Assessment Score test system. This test measures five analytes in serum, and combines their values into a single score. This score indicates the likelihood that a mass might be malignant, before surgery is undertaken to determine the nature of the mass. In this trial the risk score will be compared to pathology findings after surgery, to retrospectively assess its accuracy to predict malignancy. It is hoped that the test will enhance clinical decision-making and assist in patient referral for further surgical exploration.
Interventions
This study will benchmark the performance of the CleoDX Pre-Surgical triage Test against the use of CA125&transvaginal ultrasound to predict risk of malignancy prior to surgery in patients with an adnexal mass. Patients provide a single serum sample prior to surgical referral, in addition to that provided for standard-of-care tests. There is no patient follow-up required.
The CleoDX Pre-Surgical Test measures a combination of 5 biomarkers in serum (CA125, HE4, IL6, active CXCL10 and total CXCL1
This study will benchmark the performance of the CleoDX Pre-Surgical triage Test against the use of CA125&transvaginal ultrasound to predict risk of malignancy prior to surgery in patients with an adnexal mass. Patients provide a single serum sample prior to surgical referral, in addition to that provided for standard-of-care tests. There is no patient follow-up required. The CleoDX Pre-Surgical Test measures a combination of 5 biomarkers in serum (CA125, HE4, IL6, active CXCL10 and total CXCL10) from patients, and combines the result into a single score (from 1-10) as an indicator of malignancy risk. It is used to assist in the pre-surgical determination of likelihood that an adnexal mass may be malignant, and ensure triage to an appropriate surgical expertise for further evaluation. The test will be indicated for use in patients in whom the presence of an adnexal mass requires surgical intervention, but who have not yet been seen by an oncologist. Typically these patients will have received ultrasound imaging and CA125 test, and the results of the test indicate referral to a surgeon for secondary evaluation is warranted.
Sponsors
Cleo Diagnostics Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
Outcome results
None listed