Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT02240966
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2014-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D013736', 'term': 'Testicular Neoplasms'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-13', 'studyFirstSubmitDate': '2014-09-08', 'studyFirstSubmitQcDate': '2014-09-12', 'lastUpdatePostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Metabolic Syndrome in the three groups of testicular cancer survivors according to International Diabetes Federation Guidelines and US National Cholesterol Education Program Adult Treatment Panel III criteria', 'timeFrame': 'Up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Lean body mass (Kilogram)', 'timeFrame': 'Up to 12 months', 'description': 'Lean body mass assessed by DXA-scan'}, {'measure': 'Bone Mineral Density (Gram/cm2)', 'timeFrame': 'Up to 12 months', 'description': 'Bone mineral density assessed by DXA-scan'}, {'measure': 'Pulmonary Function: Total lung capacity, Forced vital capacity, FEV1, Diffusing capacity or of the lung for carbon monoxide', 'timeFrame': 'Up to 12 months'}, {'measure': 'Renal function (Glomerular Filtration Rate ml/min)', 'timeFrame': 'Up to 12 months', 'description': 'Renal function is assessed with 51Cr-EDTA'}, {'measure': 'Fasting Blood Glucose', 'timeFrame': 'Up to 12 months'}, {'measure': 'plasma-insulin', 'timeFrame': 'Up to 12 months'}, {'measure': 'Adiponectin and leptin', 'timeFrame': 'Up to 12 months'}, {'measure': 'Ultrasonic appearance and size of the remaining testicle', 'timeFrame': 'Up to 12 months', 'description': 'Ultrasonic appearance and size of the remaining of testicle assessed by ultrasound'}, {'measure': 'Quality of life', 'timeFrame': 'Up to 12 months', 'description': 'Quality of Life is assessed by the EORTC QLQ-30 Questionnaire'}, {'measure': 'Anxiety and depression', 'timeFrame': 'Up to 12 months', 'description': 'Anxiety and depression is assessed by the questionnaire: Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Fatigue', 'timeFrame': 'Up to 12 months', 'description': 'Fatigue is assessed by the questionnaire: Multidimensional Fatigue Inventory (MFI-20)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Testicular Neoplasms', 'Hypogonadism', 'Metabolic Syndrome', 'Treatment related late effects'], 'conditions': ['Metabolic Syndrome', 'Hypogonadism', 'Cardio-vascular Disease']}, 'referencesModule': {'references': [{'pmid': '28772110', 'type': 'DERIVED', 'citation': 'Bandak M, Jorgensen N, Juul A, Lauritsen J, Oturai PS, Mortensen J, Hojman P, Helge JW, Daugaard G. Leydig cell dysfunction, systemic inflammation and metabolic syndrome in long-term testicular cancer survivors. Eur J Cancer. 2017 Oct;84:9-17. doi: 10.1016/j.ejca.2017.07.006. Epub 2017 Jul 31.'}, {'pmid': '28598554', 'type': 'DERIVED', 'citation': 'Bandak M, Jorgensen N, Juul A, Lauritsen J, Kier MGG, Mortensen MS, Oturai PS, Mortensen J, Hojman P, Helge JW, Daugaard G. Reproductive hormones and metabolic syndrome in 24 testicular cancer survivors and their biological brothers. Andrology. 2017 Jul;5(4):718-724. doi: 10.1111/andr.12355. Epub 2017 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the prevalence of signs and symptoms of hypogonadism in three groups of testicular cancer survivors.', 'detailedDescription': 'Recent studies have shown that metabolic syndrome is common among testicular cancer. Patients with low levels of testosterone appear to be at higher risk of metabolic syndrome.\n\nA substantial number of testicular cancer survivors might be in a state of "compensated hypogonadism" with testosterone levels low in the normal range due to an increased LH-drive from the pituitary gland.\n\nWhether this specific groups of testicular cancer survivors are at increased risk of cardio-vascular disease and might benefit from testosterone substitution is yet to be clarified.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Testicular cancer survivors', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Earlier treatment of testicular germ cell cancer\n* No sign of relapse \\> 1 year since latest treatment\n* Testosterone \\< 12 nmol/L and luteinizing hormone \\> 8 IE/L OR\n* Testosterone \\> 12 nmol/L and LH \\> 8 IE/L OR\n* Testosterone and LH within their normal ranges\n\nExclusion Criteria:\n\n* Testosterone substitution'}, 'identificationModule': {'nctId': 'NCT02240966', 'briefTitle': 'Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors', 'orgStudyIdInfo': {'id': 'H-3-2013-1 75'}}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Gedske Daugaard, DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mikkel Bandak', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}