Recruiting

Cancer Risk Evaluation

Sponsor:

Cleo Diagnostics Ltd

Code:

NCT06566716

Conditions

Ovarian Neoplasms

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CleoDX ovarian cancer test

Study Details

Brief 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.

Conditions

Ovarian Neoplasms

Study ID

NCT06566716

Start date

Sep 6, 2024

Status verified date

Aug, 2024

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Any prior confirmed diagnosis of, or treatment for, ovarian cancer
  • Any prior surgery resulting in removal of both ovaries
  • Prior history of gynecological malignancy (within last 2 years)
  • Prior history of melanoma (within last 2 years)
  • Prior treatment (within 12 months of sample collection) with chemotherapy, radiotherapy or immunotherapy
  • Immune-compromised. Definition: 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).
  • Pregnant currently or within the last 3 months based on participant self-report

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

CleoDX ovarian cancer test

A diagnostic test to assist in predicting risk of malignancy prior to surgery for patients with an adnexal mass.

Primary outcome measure

  • Calculation of the CleoDX adnexal mass score [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Assoc. Director of Operations Assoc. Director of Operations

1-855-264-4064cleo_csp01001@lindushealth.com

Trial Coordinator

1-855-264-4064cleo_csp01001@lindushealth.com

Locations

New Horizons Clinical Trials

Recruiting

Chandler, Arizona, United States, 85224

Contacts

Monte Swarup, MD

480 496-2236Mswarup@womenshealthaz.com

Emerald Coast Clinical Research

Recruiting

Panama City, Florida, United States, 32405

Contacts

Samuel Wolf, DO

850-250-0194swolfdo@gmail.com

Women's Cancer Center of Nevada

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Nicola M Spirtos

702 851 4672nmspirtos@wccenter.com

The Jackson Clinic

Recruiting

Jackson, Tennessee, United States, 38305

Contacts

Daniel Fleming, DO

731-660-8396dfleming@jacksonclinic.com

Next Innovative Clinical Research

Recruiting

Houston, Texas, United States, 77008

Contacts

Arturo Sandoval, MD

312-761-4244Arturo.Sandoval@nexticr.com

Prime Clinical Research - Lewisville

Recruiting

Lewisville, Texas, United States, 75067

Contacts

Munira Dudhbhai

817-907-7330mdudhbhai@primeclinicalresearchinc.com

Vast Clinical Research-Holy Cross

Recruiting

Mesquite, Texas, United States, 75149

Contacts

Maduka Odogwu, MD

469 862 3756dr.odogwu@vastclinicalresearch.com

Virginia Women's Health Associates

Recruiting

Annandale, Virginia, United States, 22003

Contacts

Camilla Hersh, MD

888-407-9881chersh@smrdoctors.com

More Information

Sponsor

Cleo Diagnostics Ltd

Last update posted

Feb 4, 2025

Last verified

Aug, 2024

Keywords

  • ovarian
  • adnexal
  • benign
  • malignant
  • cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cleo Diagnostics Ltd on 2025-02-04.