Validation of Ovarian Adnexal Mass Assessment Score Test System

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• female patients =\> 18 years of age at the time of consent

• Can provide written informed consent

• Have an ovarian cyst or adnexal mass (simple, complex, or solid ovarian/pelvic mass) identified through imaging examination (e.g. transvaginal ultrasound - TVU) that requires surgery, but have not yet undergone this surgery

Locations
United States
Arizona
New Horizons Clinical Trials
RECRUITING
Chandler
Florida
Emerald Coast Clinical Research
RECRUITING
Panama City
Nevada
Women's Cancer Center of Nevada
RECRUITING
Las Vegas
Tennessee
The Jackson Clinic
RECRUITING
Jackson
Texas
Next Innovative Clinical Research
RECRUITING
Houston
Prime Clinical Research - Lewisville
RECRUITING
Lewisville
Vast Clinical Research-Holy Cross
RECRUITING
Mesquite
Virginia
Virginia Women's Health Associates
RECRUITING
Annandale
Contact Information
Primary
Assoc. Director of Operations Assoc. Director of Operations
cleo_csp01001@lindushealth.com
1-855-264-4064
Backup
Trial Coordinator
cleo_csp01001@lindushealth.com
1-855-264-4064
Time Frame
Start Date: 2024-09-06
Estimated Completion Date: 2026-08
Participants
Target number of participants: 1000
Treatments
Malignant
Patients with an adnexal mass that is surgically diagnosed as malignant
Non-Malignant
Patients with an adnexal mass that is surgically diagnosed as benign
Related Therapeutic Areas
Sponsors
Collaborators: Lindus Health
Leads: Cleo Diagnostics Ltd

This content was sourced from clinicaltrials.gov