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NCT06566716 · ClinicalTrials.gov registry record

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

A clinical trial of Ovarian Neoplasms, sponsored by Cleo Diagnostics.

Recruiting
Registry status
1,000
Enrollment target
8
Study locations

NCT06566716 is a study of Ovarian Neoplasms that is actively recruiting participants, run by Cleo Diagnostics. The registered enrollment target is 1,000 participants, above the 342-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (192% higher). The trial reports 8 study locations across 6 states.

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The verdict

NCT06566716, a study of Ovarian Neoplasms, is actively recruiting participants, sponsored by Cleo Diagnostics.

RECRUITING
Registry status
1,000 participants
Enrollment target
8
Study locations

Study 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 Studied

Ovarian Neoplasms

Interventions

  • DIAGNOSTIC_TEST CleoDX ovarian cancer test

Study Locations (8)

Texas

  • Next Innovative Clinical Research - Houston
  • Prime Clinical Research - Lewisville - Lewisville
  • Vast Clinical Research-Holy Cross - Mesquite

Arizona

  • New Horizons Clinical Trials - Chandler

Florida

  • Emerald Coast Clinical Research - Panama City

Nevada

  • Women's Cancer Center of Nevada - Las Vegas

Tennessee

  • The Jackson Clinic - Jackson

Virginia

  • Virginia Women's Health Associates - Annandale

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2024-09-06
Est. Completion 2026-08

Sponsor

Cleo Diagnostics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06566716

The ClinicalTrials.gov registry entry for NCT06566716 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 342-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (192% higher). The listed sponsor is Cleo Diagnostics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Ovarian Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which CleoDX ovarian cancer test is the first listed.

NCT06566716 reports 8 study locations spanning 6 distinct geographic areas - top geographies include Texas, Arizona, Florida.

Frequently Asked Questions

What is clinical trial NCT06566716 about?

NCT06566716 is a clinical study titled "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...

What is the current status of trial NCT06566716?

This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2024-09-06. Estimated completion is 2026-08.

What conditions does trial NCT06566716 study?

This clinical trial studies the following conditions: Ovarian Neoplasms.

What interventions are being tested in trial NCT06566716?

The interventions under investigation include: CleoDX ovarian cancer test (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT06566716?

This trial is sponsored by Cleo Diagnostics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06566716 being conducted?

This trial has 8 study locations across Arizona, Florida, Nevada, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.