Clinical trial NCT06566716: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Neoplasms
Keywords: ovarian
adnexal
benign
malignant
cancer
Lead sponsor: Cleo Diagnostics Ltd
Sponsor class: INDUSTRY
Collaborators: name: Lindus Health
First posted: 2024-08-22
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants identified at general medical clinics and hospital in-patient gynecology clinics with visible ovarian or pelvic abnormality on ultrasound

Brief 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.


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

Primary outcomes:
measure: Calculation of the CleoDX adnexal mass score
timeFrame: 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 outcomes:
measure: Compare CleoDX adnexal mass score with pre- and post-surgical clinicopathologic information
timeFrame: 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.
measure: Determine performance and accuracy of the CleoDX test against post-surgical pathology findings
timeFrame: 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.
measure: Identify rate of accurately predicted diagnoses by CleoDX compared to that of standard clinical workflow
timeFrame: 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.
Other outcomes:
Locations:
city: Chandler
country: United States
facility: New Horizons Clinical Trials
state: Arizona
city: Panama City
country: United States
facility: Emerald Coast Clinical Research
state: Florida
city: Las Vegas
country: United States
facility: Women's Cancer Center of Nevada
state: Nevada
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Houston
country: United States
facility: Next Innovative Clinical Research
state: Texas
city: Lewisville
country: United States
facility: Prime Clinical Research - Lewisville
state: Texas
city: Mesquite
country: United States
facility: Vast Clinical Research-Holy Cross
state: Texas
city: Annandale
country: United States
facility: Virginia Women's Health Associates
state: Virginia
Study officials:
affiliation: Cleo Diagnostics Ltd
name: Chief Scientific Officer
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.