Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 1:15 AM
Study NCT ID:
NCT07396402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-09
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SCUBE Proteins in Polycystic Ovary Syndrome (IPSOS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2026-02-02', 'studyFirstSubmitQcDate': '2026-02-02', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circulating SCUBE-1 levels', 'timeFrame': 'At enrollment', 'description': 'Comparison of SCUBE-1 plasma concentrations among normoinsulinemic PCOS, hyperinsulinemic PCOS, and healthy controls'}], 'secondaryOutcomes': [{'measure': 'Circulating SCUBE-3 levels', 'timeFrame': 'At enrollment', 'description': 'Comparison of SCUBE-3 plasma concentrations among study groups'}, {'measure': 'Correlation with clinical and laboratory parameters', 'timeFrame': 'At enrollment', 'description': 'Association between SCUBE-1 and SCUBE-3 levels and clinical (age, BMI, hirsutism, acne, menstrual irregularities) and laboratory variables (lipid profile, androgen levels)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SCUBE-1', 'SCUBE-3', 'Polycystic Ovary Syndrome', 'PCOS', 'Insulin Resistance', 'Inflammation', 'Cardiovascular Risk'], 'conditions': ['Polycystic Ovary Syndrome (PCOS)', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'This study investigates circulating levels of SCUBE-1 and SCUBE-3 proteins in women with polycystic ovary syndrome (PCOS) compared with healthy controls. Differences between normoinsulinemic and hyperinsulinemic PCOS subgroups will be evaluated, as well as correlations with clinical and metabolic parameters related to inflammation and cardiovascular risk.', 'detailedDescription': 'Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age and is frequently associated with insulin resistance, chronic low-grade inflammation, and increased cardiovascular risk.\n\nSCUBE proteins (Signal peptide-CUB-EGF domain-containing proteins) are recently identified molecules involved in inflammation, angiogenesis, and platelet activation. Their role in PCOS has not been fully elucidated.\n\nThis interventional, non-randomized study will measure circulating SCUBE-1 and SCUBE-3 levels in women with PCOS and healthy controls. PCOS patients will be stratified into normoinsulinemic and hyperinsulinemic subgroups based on previously performed metabolic assessments. Blood samples will be collected during routine clinical practice and analyzed using ELISA assays. The study aims to assess SCUBE proteins as potential biomarkers of inflammation and cardiovascular risk in PCOS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects aged 18-35 years\n* Diagnosis of polycystic ovary syndrome (normoinsulinemic or hyperinsulinemic)\n* Availability of basal hormonal evaluation and oral glucose tolerance test\n* Healthy women for control group\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* History of cardiovascular disease\n* Diabetes mellitus or impaired glucose tolerance\n* Hypertension\n* Significant hepatic or renal disease\n* Other endocrine disorders\n* Neoplastic diseases\n* Psychiatric disorders\n* Autoimmune diseases\n* Shift work\n* Obesity\n* Refusal to sign informed consent'}, 'identificationModule': {'nctId': 'NCT07396402', 'acronym': 'IPSOS', 'briefTitle': 'SCUBE Proteins in Polycystic Ovary Syndrome (IPSOS)', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Study of Scube-1 and Scube-3 in Polycystic Ovary Syndrome (PCOS) and Their Possible Use as Inflammatory Markers and as a Link Between PCOS and Cardiovascular Events.', 'orgStudyIdInfo': {'id': '7725'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: PCOS - Normoinsulinemic', 'description': 'Description: Women with PCOS and normal insulin sensitivity Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA', 'interventionNames': ['Diagnostic Test: Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: PCOS - Hyperinsulinemic', 'description': 'Description: Women with PCOS and insulin resistance Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA', 'interventionNames': ['Diagnostic Test: Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: Healthy Controls', 'description': 'Description: Healthy women of reproductive age without PCOS Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA', 'interventionNames': ['Diagnostic Test: Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement']}], 'interventions': [{'name': 'Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood sample collection performed specifically for research purposes to measure circulating SCUBE-1 and SCUBE-3 levels using enzyme-linked immunosorbent assay (ELISA).', 'armGroupLabels': ['Arm 1: PCOS - Normoinsulinemic', 'Arm 2: PCOS - Hyperinsulinemic', 'Arm 3: Healthy Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'contacts': [{'name': 'Rosanna Apa, MD, PhD', 'role': 'CONTACT', 'email': 'rosanna.apa@policlinicogemelli.it', 'phone': '+390630155872'}], 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Rosanna Apa, MD, PhD', 'role': 'CONTACT', 'email': 'rosanna.apa@policlinicogemelli.it', 'phone': '+390630155872'}, {'name': 'Anna Tropea, MD, PhD', 'role': 'CONTACT', 'email': 'anna.tropea@policlinicogemelli.it', 'phone': '+390630155872'}], 'overallOfficials': [{'name': 'Rosanna Apa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}