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NCT Number: NCT06566716

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

New Horizons Clinical Trials, Chandler, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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.

    Correlate post-surgical pathology findings with the CleoDX adnexal mass score, and evaluate the performance metrics (including sensitivity, specificity, Negative Predictive Value and Positive Predictive Value) of the CleoDX adnexal mass assessment scoring system.

  2. 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.

    Correlate post-surgical pathology findings with the CleoDX adnexal mass score, and evaluate the performance metrics (including sensitivity, specificity, Negative Predictive Value and Positive Predictive Value) of the CleoDX adnexal mass assessment scoring system.

  3. 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.

    Demonstrate superiority of the CleoDX adnexal mass scoring system compared to standard clinical workflows including CA125 and Risk of Malignancy Index (RMI) measurements.

Study contacts

Contact information is provided by the study sponsor or research team.

Assoc. Director of Operations Assoc. Director of Operations

CONTACT

[email protected]

1-855-264-4064

Trial Coordinator

CONTACT

[email protected]

1-855-264-4064

Sponsors and collaborators

Lead sponsor

Cleo Diagnostics Ltd

Industry

Collaborators

  • Lindus Health

Registry information

Official study title

Validation of Ovarian Adnexal Mass Assessment Score Test System

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 22, 2024
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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