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

Official title

Validation of Ovarian Adnexal Mass Assessment Score Test System

Overview

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.

Interventions

• Diagnostic test 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 measures

• 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.]

Secondary outcome measures (3)

• Compare CleoDX adnexal mass score with pre- and post-surgical clinicopathologic information [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.]
• Determine performance and accuracy of the CleoDX test against post-surgical pathology findings [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.]
• Identify rate of accurately predicted diagnoses by CleoDX compared to that of standard clinical workflow [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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-control

Study locations

United States · 8 centers

• New Horizons Clinical Trials — Chandler
• Emerald Coast Clinical Research — Panama City
• Women's Cancer Center of Nevada — Las Vegas
• The Jackson Clinic — Jackson
• Next Innovative Clinical Research — Houston
• Prime Clinical Research - Lewisville — Lewisville
• Vast Clinical Research-Holy Cross — Mesquite
• Virginia Women's Health Associates — Annandale

Publications

• 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
• 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
• 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

Identifiers

NCT: NCT06566716 · CSP-01-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗