RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Validation of Ovarian Adnexal Mass Assessment Score Test System

Quick Facts

Study Start:2024-09-06
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06566716

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * female patients =\> 18 years of age at the time of consent
  2. * Can provide written informed consent
  3. * 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
  1. * Any prior confirmed diagnosis of, or treatment for, ovarian cancer
  2. * Any prior surgery resulting in removal of both ovaries
  3. * Prior history of gynecological malignancy (within last 2 years)
  4. * Prior history of melanoma (within last 2 years)
  5. * Prior treatment (within 12 months of sample collection) with chemotherapy, radiotherapy or immunotherapy
  6. * 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).
  7. * Pregnant currently or within the last 3 months based on participant self-report

Contacts and Locations

Study Contact

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

Principal Investigator

Chief Scientific Officer
STUDY_DIRECTOR
Cleo Diagnostics Ltd

Study Locations (Sites)

New Horizons Clinical Trials
Chandler, Arizona, 85224
United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106
United States
ES Clinical Research Group LLC
Fresh Meadows, New York, 11365
United States
Prime Clinical Research - Lewisville
Lewisville, Texas, 75067
United States
Vast Clinical Research-Holy Cross
Mesquite, Texas, 75149
United States

Collaborators and Investigators

Sponsor: Cleo Diagnostics Ltd

  • Chief Scientific Officer, STUDY_DIRECTOR, Cleo Diagnostics Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-06
Study Completion Date2026-08

Study Record Updates

Study Start Date2024-09-06
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

  • ovarian
  • adnexal
  • benign
  • malignant
  • cancer

Additional Relevant MeSH Terms

  • Ovarian Neoplasms