A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass
NCT ID: NCT06566716
Last Updated: 2025-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2024-09-06
2026-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Malignant
Patients with an adnexal mass that is surgically diagnosed as malignant
CleoDX ovarian cancer test
A diagnostic test to assist in predicting risk of malignancy prior to surgery for patients with an adnexal mass.
Non-Malignant
Patients with an adnexal mass that is surgically diagnosed as benign
CleoDX ovarian cancer test
A diagnostic test to assist in predicting risk of malignancy prior to surgery for patients with an adnexal mass.
Interventions
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CleoDX ovarian cancer test
A diagnostic test to assist in predicting risk of malignancy prior to surgery for patients with an adnexal mass.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Lindus Health
INDUSTRY
Cleo Diagnostics Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Scientific Officer
Role: STUDY_DIRECTOR
Cleo Diagnostics Ltd
Locations
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New Horizons Clinical Trials
Chandler, Arizona, United States
Emerald Coast Clinical Research
Panama City, Florida, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
The Jackson Clinic
Jackson, Tennessee, United States
Next Innovative Clinical Research
Houston, Texas, United States
Prime Clinical Research - Lewisville
Lewisville, Texas, United States
Vast Clinical Research-Holy Cross
Mesquite, Texas, United States
Virginia Women's Health Associates
Annandale, Virginia, United States
Countries
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Central Contacts
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Assoc. Director of Operations Assoc. Director of Operations
Role: CONTACT
Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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CSP-01-001
Identifier Type: -
Identifier Source: org_study_id
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