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Non-Malignant for Ovarian Tumors

N/A
Recruiting
Research Sponsored by Cleo Diagnostics Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up outcomes will be assessed during an analysis phase, which will commence after completion of patient recruitment and continue for up to 12 months or the end of the study period is reached (august 2026), whichever occurs first.
Awards & highlights

Summary

Ovarian cancer is a serious health risk with the highest death rate among gynecological cancers. Unfortunately, it's only possible to definitively diagnose ovarian cancer after surgery, as there are no reliable tests to determine if an ovarian abnormality is cancerous or benign before surgery. Cleo Diagnostics have developed a new test that uses five biomarkers in the blood to better differentiate between benign and malignant ovarian conditions. In initial studies, this test outperformed the current standard test, CA125, in identifying cancer. This study aims to evaluate the effectiveness of the Cleo Diagnostics (CleoDX) Ovarian Adnexal Mass Score Test System. This test measures five analytes in the blood and provides a score indicating the likelihood of cancer in patients with an adnexal mass requiring surgery. The test is designed to assist doctors in making better-informed decisions about surgery and patient care by providing a more accurate pre-surgical assessment of cancer risk. By doing so, it aims to improve patient outcomes and ensure that those with malignant conditions receive the appropriate specialist care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcomes will be assessed during an analysis phase, which will commence after completion of patient recruitment and continue for up to 12 months or the end of the study period is reached (august 2026), whichever occurs first.
This trial's timeline: 3 weeks for screening, Varies for treatment, and outcomes will be assessed during an analysis phase, which will commence after completion of patient recruitment and continue for up to 12 months or the end of the study period is reached (august 2026), whichever occurs first. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Calculation of the CleoDX adnexal mass score
Secondary study objectives
Compare CleoDX adnexal mass score with pre- and post-surgical clinicopathologic information
Determine performance and accuracy of the CleoDX test against post-surgical pathology findings
Identify rate of accurately predicted diagnoses by CleoDX compared to that of standard clinical workflow

Trial Design

2Treatment groups
Experimental Treatment
Group I: Non-MalignantExperimental Treatment1 Intervention
Patients with an adnexal mass that is surgically diagnosed as benign
Group II: MalignantExperimental Treatment1 Intervention
Patients with an adnexal mass that is surgically diagnosed as malignant

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Who is running the clinical trial?

Lindus HealthIndustry Sponsor
9 Previous Clinical Trials
15,130 Total Patients Enrolled
Cleo Diagnostics LtdLead Sponsor
Chief Scientific OfficerStudy DirectorCleo Diagnostics Ltd
9 Previous Clinical Trials
1,612 Total Patients Enrolled
~667 spots leftby Aug 2025
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