Trial Title:
A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women With an Ovarian Mass
NCT ID:
NCT06566716
Condition:
Ovarian Neoplasms
Conditions: Official terms:
Ovarian Neoplasms
Conditions: Keywords:
ovarian
adnexal
benign
malignant
cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
CleoDX ovarian cancer test
Description:
A diagnostic test to assist in predicting risk of malignancy prior to surgery for
patients with an adnexal mass.
Arm group label:
Malignant
Arm group label:
Non-Malignant
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.
Criteria for eligibility:
Study pop:
Participants identified at general medical clinics and hospital in-patient gynecology
clinics with visible ovarian or pelvic abnormality on ultrasound
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
New Horizons Clinical Trials
Address:
City:
Chandler
Zip:
85224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Monte Swarup, MD
Phone:
480-496-2236
Email:
Mswarup@womenshealthaz.com
Facility:
Name:
Zillan Clinical Research
Address:
City:
Inglewood
Zip:
90303
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nwachukwu Anakwenze
Phone:
310-677-4600
Email:
site@zillanclinicalresearch.com
Facility:
Name:
GYN Research Institute
Address:
City:
Kissimmee
Zip:
34741
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anthony Gyang
Phone:
407-556-3973
Email:
tonygyang@hotmail.com
Facility:
Name:
Innovation Clinical Trials INC
Address:
City:
Palmetto Bay
Zip:
33157
Country:
United States
Status:
Recruiting
Contact:
Last name:
Juan Ruiz-Unger, MD
Phone:
786-298-5170
Email:
junger@innovationclinicaltrials.com
Facility:
Name:
Women's Cancer Center of Nevada
Address:
City:
Las Vegas
Zip:
89106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nicola M Spirtos
Phone:
702-851-4672
Email:
nmspirtos@wccenter.com
Facility:
Name:
ES Clinical Research Group LLC
Address:
City:
Fresh Meadows
Zip:
11365
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ziyad A Mansur
Phone:
713-724-6863
Email:
ziyadmansur@hotmail.com
Facility:
Name:
Prime Clinical Research - Lewisville
Address:
City:
Lewisville
Zip:
75067
Country:
United States
Status:
Recruiting
Contact:
Last name:
Munira Dudhbhai
Phone:
817-907-7330
Email:
mdudhbhai@primeclinicalresearchinc.com
Facility:
Name:
Vast Clinical Research-Holy Cross
Address:
City:
Mesquite
Zip:
75149
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maduka Odogwu, MD
Phone:
469-862-3756
Email:
dr.odogwu@vastclinicalresearch.com
Start date:
September 5, 2024
Completion date:
August 2026
Lead sponsor:
Agency:
Cleo Diagnostics Ltd
Agency class:
Industry
Collaborator:
Agency:
Lindus Health
Agency class:
Industry
Source:
Cleo Diagnostics Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06566716
