Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT05773651
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2023-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rare Tumours in Children and Adolescents (STEP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '50 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2055-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2050-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free survival', 'timeFrame': '5 years', 'description': 'Period between study entry and failure of induction therapy, recurrence or death from any cause is measured.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epidemiological data collection', 'Rare tumors in children', 'Rare tumors in adolescents', 'Clinical data collection'], 'conditions': ['Rare Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.seltene-tumoren.de/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of the STEP registry is to collect and evaluate experience and data on the diagnosis and treatment of rare childhood tumors in order to use the knowledge gained to improve the treatment prospects for our patients. The rarity of a disease should not be a disadvantage for the young patients.', 'detailedDescription': 'The objective of the STEP registry is to optimise the diagnosis and treatment of patients with rare tumour diseases in childhood and adolescence. Therefore, a continuous prospective collection of clinical data on rare paediatric tumours is conducted to improve the understanding of these tumours. Beyond analysis of clinical data, further scientific research on the biological and molecular genetic characteristics of these tumours is performed. These data and a close collaboration with international partners, especially the European EXPeRT group, enable the improvement of treatment recommendations for these tumours along with establishment a global interdisciplinary network of rare tumour specialists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adolescents with rare solid tumors from primary care clinic, university hospitals, specialty centers, ...', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of a rare solid tumor\n* Age at diagnosis: Neonatal period to 18 years (In the case of young adults, registration in the database and/or referral to advisory contact persons within the framework of the competence network can take place upon request and after declaration of consent.)\n* Information, education, written consent of the patient or the guardian\n* Not recorded in any of the existing clinical studies/ registers of the German Society for Pediatric Oncology and Hematology (GPOH)\n\nExclusion Criteria:\n\n* Registration of the tumor diagnosis in a prospective therapy study/ another clinical registry of the GPOH\n* Lack of information, explanation and/or written consent of the patient or the legal guardian.'}, 'identificationModule': {'nctId': 'NCT05773651', 'acronym': 'STEP 2 0', 'briefTitle': 'Rare Tumours in Children and Adolescents (STEP)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Rare Tumours in Children and Adolescents (STEP 2.0) - Register for the Documentation of Rare Tumours in Children and Adolescents', 'orgStudyIdInfo': {'id': 'STEP 2.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rare tumor disease', 'description': 'Prospective epidemiological and clinical data collection of subjects with diagnosis of a rare solid tumor.', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'The data collection includes, among other things: Diagnosis of the rare tumor (pathological findings/ reference pathological findings), full name, birth date, gender, clinical registry inclusion and exclusion criteria met - yes / no, signed declaration of consent-yes / no, if yes: date of signature', 'armGroupLabels': ['Rare tumor disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ines Brecht, PD Dr. med.', 'role': 'CONTACT', 'email': 'ines.brecht@med.uni-tuebingen.de', 'phone': '+49 7071 29', 'phoneExt': '81380'}, {'name': 'Michael Abele, Dr. med.', 'role': 'CONTACT', 'email': 'michael.abele@med.uni-tuebingen.de', 'phone': '+49 7071 29', 'phoneExt': '61387'}], 'facility': 'University Hospital Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Ines Brecht, PD Dr. med.', 'role': 'CONTACT', 'email': 'ines.brecht@med.uni-tuebingen.de', 'phone': '+49 7071 29', 'phoneExt': '81380'}, {'name': 'Michael Abele, Dr. med.', 'role': 'CONTACT', 'email': 'michael.abele@med.uni-tuebingen.de', 'phone': '+49 7071 29', 'phoneExt': '61837'}], 'overallOfficials': [{'name': 'Ines Brecht, PD Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Tübingen'}, {'name': 'Dominik Schneider, Prof. Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinic for Pediatric and Adolescent Medicine at Dortmund Hospital'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data will become available after analysis and unlimited.', 'ipdSharing': 'YES', 'description': 'The STEP Register will provide data in a pseudonymised manner to national and international databases set up to optimize the diagnosis and treatment of rare tumors in children and adolescents'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}