A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass

NCT06566716 | Recruiting

• 1 other identifier: CSP-01-001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 8

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

Keywords

ovarian; adnexal; benign; malignant; cancer

Outcome Measures

Primary Outcomes (1)

• Calculation of the CleoDX adnexal mass score

  Determine the Cleo Diagnostics (CleoDX) adnexal mass score in patients identified with an adnexal mass requiring surgery, but who have not yet undergone this surgery.

  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.

Secondary Outcomes (3)

• Compare CleoDX adnexal mass score with pre- and post-surgical clinicopathologic information

  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.

• Determine performance and accuracy of the CleoDX test against post-surgical pathology findings

  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.

• Identify rate of accurately predicted diagnoses by CleoDX compared to that of standard clinical workflow

  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.

Study Arms (2)

Malignant

Patients with an adnexal mass that is surgically diagnosed as malignant

Diagnostic Test: CleoDX ovarian cancer test

Non-Malignant

Patients with an adnexal mass that is surgically diagnosed as benign

Diagnostic Test: CleoDX ovarian cancer test

Interventions

CleoDX ovarian cancer test DIAGNOSTIC_TEST

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

Malignant; Non-Malignant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants identified at general medical clinics and hospital in-patient gynecology clinics with visible ovarian or pelvic abnormality on ultrasound

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cleo Diagnostics Ltd: lead
• Lindus Health: collaborator

Study Sites (8)

New Horizons Clinical Trials

Chandler, Arizona, 85224, United States

RECRUITING

Emerald Coast Clinical Research

Panama City, Florida, 32405, United States

RECRUITING

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89106, United States

RECRUITING

The Jackson Clinic

Jackson, Tennessee, 38305, United States

RECRUITING

Next Innovative Clinical Research

Houston, Texas, 77008, United States

RECRUITING

Prime Clinical Research - Lewisville

Lewisville, Texas, 75067, United States

RECRUITING

Vast Clinical Research-Holy Cross

Mesquite, Texas, 75149, United States

RECRUITING

Virginia Women's Health Associates

Annandale, Virginia, 22003, United States

RECRUITING

Related Publications (3)

• Stephens AN, Hobbs SJ, Kang SW, Bilandzic M, Rainczuk A, Oehler MK, Jobling TW, Plebanski M, Allman R. A Novel Predictive Multi-Marker Test for the Pre-Surgical Identification of Ovarian Cancer. Cancers (Basel). 2023 Nov 2;15(21):5267. doi: 10.3390/cancers15215267.

  PMID: 37958440 BACKGROUND

• Stephens AN, Hobbs SJ, Kang SW, Oehler MK, Jobling TW, Allman R. Utility of a Multi-Marker Panel with Ultrasound for Enhanced Classification of Adnexal Mass. Cancers (Basel). 2024 May 28;16(11):2048. doi: 10.3390/cancers16112048.

  PMID: 38893167 BACKGROUND

• Stephens AN, Hobbs SJ, Kang SW, Oehler MK, Jobling TW, Allman R. ReClassification of Patients with Ambiguous CA125 for Optimised Pre-Surgical Triage. Diagnostics (Basel). 2024 Mar 22;14(7):671. doi: 10.3390/diagnostics14070671.

  PMID: 38611584 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Chief Scientific Officer

  Cleo Diagnostics Ltd

  STUDY DIRECTOR

Central Study Contacts

Assoc. Director of Operations Assoc. Director of Operations

CONTACT

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

Trial Coordinator

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2024
• First Posted: August 22, 2024
• Study Start: September 6, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 4, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)