CleoDX

Clinical Trials

Cleo Diagnostics is currently recruiting patients in studies evaluating our pre-surgical triage test

Study Title : Validation of an Ovarian Adnexal Mass Assessment Score Test System

HREC Reference Number : HREC/103505/MonH-2023-402747(v1)

Monash Health Local Reference : RES-23-0000-789A

Protocol Number : CSP-01-002

Link to NHMRC site : https://www.anzctr.org.au/ACTRN12624000882527.aspx

Registration Number : ACTRN12624000882527

Study purpose
Prospective observational trial to benchmark the performance of the CleoDX Pre-Surgical Triage Test against CA125 & ultrasound to indicate risk of ovarian malignancy.

Target population
Patients with an ovarian or adnexal mass for which surgical referral is required, but who have not yet been referred to an oncologist (note: exclusion criteria include previous ovarian cancer and / or bilateral oophorectomy).

Requirements
Patients will be asked to provide a single serum sample for analysis, along with access to their relevant medical records and post-surgical outcomes.

Intervention/Impact
This is an observational trial only. There is no intervention and no impact to patients.

Recruitment is via general practice and/or general gynaecology clinics in Australia.

If you are a physician interested in participating in this study, please contact the trial co-ordinator: clinical.trials@cleodx.com