Ovarian NeoplasmsNCT06566716
A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women With an Ovarian Mass
An observational study of Ovarian Neoplasms, run by Cleo Diagnostics Ltd at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- CleoDX ovarian cancer test
- How many people
- 1,000 participants
- Where
- 19 sitesUnited States
- Study dates
- 6 Sep 2024to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants identified at general medical clinics and hospital in-patient gynecology clinics with visible ovarian or pelvic abnormality on ultrasound
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Virginia Women's Health Associates
Annandale, Virginia, 22003
Dana-Farber Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
New Horizons Clinical Trials
Chandler, Arizona, 85224
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Medical Centre
Durham, North Carolina, 27710
Next Innovative Clinical Research
Houston, Texas, 77008
Women's Health Pavilion
Howard Beach, New York, 11414
The Jackson Clinic
Jackson, Tennessee, 38305
University of Florida - Jacksonville
Jacksonville, Florida, 32209
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106
Maximos Ob/Gyn
League City, Texas, 77573
Prime Clinical Research - Lewisville
Lewisville, Texas, 75067
Vast Clinical Research-Holy Cross
Mesquite, Texas, 75149
HCA Florida Physicians
Miami, Florida, 33173
Velocity Clinical Research - Annapolis
Miami, Florida, 33176
Columbia University Irving Medical Center
New York, New York, 10032
Emerald Coast Clinical Research
Panama City, Florida, 32405
Rush University Medical Centre
Poughkeepsie, New York, 12601
Springfield Clinic
Springfield, Illinois, 62702
About this study
Official title: Validation of Ovarian Adnexal Mass Assessment Score Test System
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
- Ovarian Neoplasms
- Being tested
- CleoDX ovarian cancer test
- Keywords
- ovarian, adnexal, benign, malignant, cancer
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CleoDX ovarian cancer testDiagnostic test
A diagnostic test to assist in predicting risk of malignancy prior to surgery for patients with an adnexal mass.
| Study group | Role | What they receive |
|---|---|---|
| Malignant | Patients with an adnexal mass that is surgically diagnosed as malignant Receives: Diagnostic Test: CleoDX ovarian cancer test | |
| Non-Malignant | Patients with an adnexal mass that is surgically diagnosed as benign Receives: Diagnostic Test: CleoDX ovarian cancer test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (3)
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start6 Sep 2024
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cleo Diagnostics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Responsible party
- Sponsor
- Investigators
- Chief Scientific Officer, Study director, Cleo Diagnostics Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566716
- Sponsor's protocol ID
- CSP-01-001
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37958440Stephens 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.
PubMed 38893167Stephens 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.
PubMed 38611584
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Ovarian Adnexal Mass Assessment Score Test System
- ClinicalTrials.gov ID
- NCT06566716
- Acronym / sponsor ID
- CSP-01-001
- Conditions
- Ovarian Neoplasms
- Keywords
- ovarian, adnexal, benign, malignant, cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cleo Diagnostics LtdIndustry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malignant | – | Diagnostic Test: CleoDX ovarian cancer testPatients with an adnexal mass that is surgically diagnosed as malignant |
| Non-Malignant | – | Diagnostic Test: CleoDX ovarian cancer testPatients with an adnexal mass that is surgically diagnosed as benign |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants identified at general medical clinics and hospital in-patient gynecology clinics with visible ovarian or pelvic abnormality on ultrasound
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CleoDX ovarian cancer testA diagnostic test to assist in predicting risk of malignancy prior to surgery for patients with an adnexal mass. | Diagnostic test | Malignant, Non-Malignant |
Primary outcome
Calculation of the CleoDX adnexal mass score
Time frame: 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.
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.
3 secondary outcomes
Compare CleoDX adnexal mass score with pre- and post-surgical clinicopathologic information
Time frame: 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.
Determine performance and accuracy of the CleoDX test against post-surgical pathology findings
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 37958440Stephens 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.
- Background: PubMed 38893167Stephens 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.
- Background: PubMed 38611584Stephens 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Scientific Officer study director
Cleo Diagnostics Ltd
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms, run by Cleo Diagnostics Ltd at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of the CleoDX adnexal mass score (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06566716, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.