Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566716
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-17
Brief Title:
A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women With an Ovarian Mass
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation of Ovarian Adnexal Mass Assessment Score Test System
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ovarian cancer is a serious health risk with the highest death rate among gynecological cancers Unfortunately its 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None