Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT06566716
Status:
RECRUITING
Last Update Posted:
2025-02-04
First Post:
2024-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-02', 'studyFirstSubmitDate': '2024-08-17', 'studyFirstSubmitQcDate': '2024-08-21', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': '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.'}], 'secondaryOutcomes': [{'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.', 'description': '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.'}, {'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.', 'description': '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.'}, {'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.', 'description': 'Demonstrate superiority of the CleoDX adnexal mass scoring system compared to standard clinical workflows including CA125 and Risk of Malignancy Index (RMI) measurements.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ovarian', 'adnexal', 'benign', 'malignant', 'cancer'], 'conditions': ['Ovarian Neoplasms']}, 'referencesModule': {'references': [{'pmid': '37958440', 'type': 'BACKGROUND', '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.'}, {'pmid': '38893167', 'type': 'BACKGROUND', '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.'}, {'pmid': '38611584', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nCleo 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants identified at general medical clinics and hospital in-patient gynecology clinics with visible ovarian or pelvic abnormality on ultrasound', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female patients =\\> 18 years of age at the time of consent\n* Can provide written informed consent\n* 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\n\nExclusion Criteria:\n\n* Any prior confirmed diagnosis of, or treatment for, ovarian cancer\n* Any prior surgery resulting in removal of both ovaries\n* Prior history of gynecological malignancy (within last 2 years)\n* Prior history of melanoma (within last 2 years)\n* Prior treatment (within 12 months of sample collection) with chemotherapy, radiotherapy or immunotherapy\n* 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).\n* Pregnant currently or within the last 3 months based on participant self-report'}, 'identificationModule': {'nctId': 'NCT06566716', 'briefTitle': 'A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cleo Diagnostics Ltd'}, 'officialTitle': 'Validation of Ovarian Adnexal Mass Assessment Score Test System', 'orgStudyIdInfo': {'id': 'CSP-01-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Malignant', 'description': 'Patients with an adnexal mass that is surgically diagnosed as malignant', 'interventionNames': ['Diagnostic Test: CleoDX ovarian cancer test']}, {'label': 'Non-Malignant', 'description': 'Patients with an adnexal mass that is surgically diagnosed as benign', 'interventionNames': ['Diagnostic Test: CleoDX ovarian cancer test']}], 'interventions': [{'name': 'CleoDX ovarian cancer test', 'type': 'DIAGNOSTIC_TEST', 'description': 'A diagnostic test to assist in predicting risk of malignancy prior to surgery for patients with an adnexal mass.', 'armGroupLabels': ['Malignant', 'Non-Malignant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Monte Swarup, MD', 'role': 'CONTACT', 'email': 'Mswarup@womenshealthaz.com', 'phone': '480 496-2236'}], 'facility': 'New Horizons Clinical Trials', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '32405', 'city': 'Panama City', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samuel Wolf, DO', 'role': 'CONTACT', 'email': 'swolfdo@gmail.com', 'phone': '850-250-0194'}], 'facility': 'Emerald Coast Clinical Research', 'geoPoint': {'lat': 30.15946, 'lon': -85.65983}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicola M Spirtos', 'role': 'CONTACT', 'email': 'nmspirtos@wccenter.com', 'phone': '702 851 4672'}], 'facility': "Women's Cancer Center of Nevada", 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Fleming, DO', 'role': 'CONTACT', 'email': 'dfleming@jacksonclinic.com', 'phone': '731-660-8396'}], 'facility': 'The Jackson Clinic', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '77008', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Arturo Sandoval, MD', 'role': 'CONTACT', 'email': 'Arturo.Sandoval@nexticr.com', 'phone': '312-761-4244'}], 'facility': 'Next Innovative Clinical Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75067', 'city': 'Lewisville', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Munira Dudhbhai', 'role': 'CONTACT', 'email': 'mdudhbhai@primeclinicalresearchinc.com', 'phone': '817-907-7330'}], 'facility': 'Prime Clinical Research - Lewisville', 'geoPoint': {'lat': 33.04623, 'lon': -96.99417}}, {'zip': '75149', 'city': 'Mesquite', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maduka Odogwu, MD', 'role': 'CONTACT', 'email': 'dr.odogwu@vastclinicalresearch.com', 'phone': '469 862 3756'}], 'facility': 'Vast Clinical Research-Holy Cross', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '22003', 'city': 'Annandale', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Camilla Hersh, MD', 'role': 'CONTACT', 'email': 'chersh@smrdoctors.com', 'phone': '888-407-9881'}], 'facility': "Virginia Women's Health Associates", 'geoPoint': {'lat': 38.83039, 'lon': -77.19637}}], 'centralContacts': [{'name': 'Assoc. Director of Operations Assoc. Director of Operations', 'role': 'CONTACT', 'email': 'cleo_csp01001@lindushealth.com', 'phone': '1-855-264-4064'}, {'name': 'Trial Coordinator', 'role': 'CONTACT', 'email': 'cleo_csp01001@lindushealth.com', 'phone': '1-855-264-4064'}], 'overallOfficials': [{'name': 'Chief Scientific Officer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cleo Diagnostics Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cleo Diagnostics Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Lindus Health', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}