Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lindus Health | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Malignant | Patients with an adnexal mass that is surgically diagnosed as malignant |
| |
| Non-Malignant | Patients with an adnexal mass that is surgically diagnosed as benign |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Calculation of the CleoDX adnexal mass score | 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. | 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 | Description | Time Frame |
|---|---|---|
| Compare CleoDX adnexal mass score with pre- and post-surgical clinicopathologic information | 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. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants identified at general medical clinics and hospital in-patient gynecology clinics with visible ovarian or pelvic abnormality on ultrasound
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Chief Scientific Officer | Cleo Diagnostics Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Horizons Clinical Trials | Recruiting | Chandler | Arizona | 85224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37958440 | Background | 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. | |
| 38893167 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Serum
| Determine performance and accuracy of the CleoDX test against post-surgical pathology findings | 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. | 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. |
| Identify rate of accurately predicted diagnoses by CleoDX compared to that of standard clinical workflow | Demonstrate superiority of the CleoDX adnexal mass scoring system compared to standard clinical workflows including CA125 and Risk of Malignancy Index (RMI) measurements. | 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. |
| Emerald Coast Clinical Research | Recruiting | Panama City | Florida | 32405 | United States |
|
| Women's Cancer Center of Nevada | Recruiting | Las Vegas | Nevada | 89106 | United States |
|
| The Jackson Clinic | Recruiting | Jackson | Tennessee | 38305 | United States |
|
| Next Innovative Clinical Research | Recruiting | Houston | Texas | 77008 | United States |
|
| Prime Clinical Research - Lewisville | Recruiting | Lewisville | Texas | 75067 | United States |
|
| Vast Clinical Research-Holy Cross | Recruiting | Mesquite | Texas | 75149 | United States |
|
| Virginia Women's Health Associates | Recruiting | Annandale | Virginia | 22003 | United States |
|
| 38611584 | Background | 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. |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |