Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
Study NCT ID:
NCT04300257
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2020-02-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Swiss Sarcoma Network: Prediction Model for Patient Selection in Sarcoma Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D012516', 'term': 'Osteosarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-03-05', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis,', 'timeFrame': '5 years', 'description': 'Data collected in the registry will be evaluated and analyzed to determine criteria to improve treatment strategies'}, {'measure': 'Local recurrence,', 'timeFrame': '5 years', 'description': 's.o.'}, {'measure': 'distant metastasis,', 'timeFrame': '5 years', 'description': 's.o.'}, {'measure': 'biopsy taken by operating surgeon-radiologist-team,', 'timeFrame': '5 years', 'description': 's.o.'}, {'measure': 'pathology centrally reviewed,', 'timeFrame': '5 years', 'description': 's.o.'}, {'measure': 'Surgery (yes/no),', 'timeFrame': '5 years', 'description': 's.o.'}, {'measure': 'Surgical margin status,', 'timeFrame': '5 years', 'description': 's.o.'}, {'measure': 'surgery performed by dedicated surgeon,', 'timeFrame': '5 years', 'description': 's.o.'}, {'measure': 'Radiation Therapy (yes/no),', 'timeFrame': '5 years', 'description': 's.o.'}, {'measure': 'Chemotherapy (yes/no),', 'timeFrame': '5 years', 'description': 's.o.'}, {'measure': 'decision of board carried out,', 'timeFrame': '5 years', 'description': 's.o.'}, {'measure': 'Status at last contact,', 'timeFrame': '5 years', 'description': 's.o.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcoma, Epithelioid', 'Sarcoma, Soft Tissue', 'Sarcoma, Spindle Cell', 'Sarcoma, Bone'], 'conditions': ['Sarcoma']}, 'referencesModule': {'references': [{'pmid': '28109409', 'type': 'RESULT', 'citation': 'Andritsch E, Beishon M, Bielack S, Bonvalot S, Casali P, Crul M, Delgado Bolton R, Donati DM, Douis H, Haas R, Hogendoorn P, Kozhaeva O, Lavender V, Lovey J, Negrouk A, Pereira P, Roca P, de Lempdes GR, Saarto T, van Berck B, Vassal G, Wartenberg M, Yared W, Costa A, Naredi P. ECCO Essential Requirements for Quality Cancer Care: Soft Tissue Sarcoma in Adults and Bone Sarcoma. A critical review. Crit Rev Oncol Hematol. 2017 Feb;110:94-105. doi: 10.1016/j.critrevonc.2016.12.002. Epub 2016 Dec 8.'}, {'pmid': '29633281', 'type': 'RESULT', 'citation': 'Abarca T, Gao Y, Monga V, Tanas MR, Milhem MM, Miller BJ. Improved survival for extremity soft tissue sarcoma treated in high-volume facilities. J Surg Oncol. 2018 Jun;117(7):1479-1486. doi: 10.1002/jso.25052. Epub 2018 Apr 6.'}]}, 'descriptionModule': {'briefSummary': 'The primary significance of this project is to perform a detailed analysis to assess the diagnostics, treatment and follow-up care, to develop a prediction model for future patient selection regarding various diagnostic and treatment procedures.', 'detailedDescription': 'Within the framework of interdisciplinary cooperation for a sarcoma problem, predictive and prognostic criteria will be developed that improve the treatment and particularly outcome.\n\nThe outcome variables include patient characteristics, tumor types and characteristics, histology, management and treatment strategies as well as recurrence rate and overall survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from bone or soft tissue tumors.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Malignant and intermediate and selected benign bone or soft tissue tumors, acc. to the WHO coding list of the SSN\n* Female and male subjects of all ages\n\nExclusion Criteria:\n\n* Documented objection of subsequent use of personal health data'}, 'identificationModule': {'nctId': 'NCT04300257', 'briefTitle': 'Swiss Sarcoma Network: Prediction Model for Patient Selection in Sarcoma Care', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Winterthur KSW'}, 'officialTitle': 'Swiss Sarcoma Network: Prediction Model for Patient Selection in Sarcoma Care', 'orgStudyIdInfo': {'id': '2019-01107'}}, 'contactsLocationsModule': {'locations': [{'zip': '8400', 'city': 'Winterthur', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Stefan Breitenstein, Prof. Dr. med.', 'role': 'CONTACT', 'phone': '+41 52 266 2121'}, {'name': 'Bruno Fuchs, MD PhD', 'role': 'CONTACT', 'email': 'bruno.fuchs@ksw.ch', 'phone': '+41 52 266 2121', 'phoneExt': '2553'}], 'facility': 'Kantonsspital Winterthur', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}, {'zip': '8400', 'city': 'Winterthur', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Larissa Slater', 'role': 'CONTACT', 'email': 'larissa.slater@ksw.ch', 'phone': '+41 52 266 24 88'}], 'facility': 'SwissSarcomaNetwork', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}, {'zip': '6500', 'city': 'Bellinzona', 'state': 'Canton Ticino', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Silke Gillessen Sommer, Prof. Dr. med.', 'role': 'CONTACT', 'phone': '+41 91 811 94 10'}], 'facility': 'Ente Ospedaliero Cantonale', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}, {'zip': '7000', 'city': 'Chur', 'state': 'Kanton Graubünden', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Christian Michelitsch, Dr. med.', 'role': 'CONTACT', 'phone': '+41 81 256 62 05'}], 'facility': 'Kantonsspital Graubünden', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}, {'zip': '6000', 'city': 'Lucerne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Gabriela Studer, Prof. Dr. med.', 'role': 'CONTACT', 'phone': '+41 41 205 58 01'}], 'facility': 'Luzerner Kantonsspital', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'zip': '8005', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Beata Bode, Prof. Dr. med.', 'role': 'CONTACT', 'phone': '+41 44 287 38 38'}], 'facility': 'Pathologie Institut Enge', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8032', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Paul Magnus Schneider, Prof. Dr.', 'role': 'CONTACT', 'email': 'sekretariat.professor-schneider@hin.ch', 'phone': '+41 44 387 31 66'}, {'name': 'Annelies Schnider, Dr. med.', 'role': 'CONTACT'}], 'facility': 'Klinik Hirslanden', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8063', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Markus Weber, Prof. Dr. med. Dr. h.c.', 'role': 'CONTACT', 'phone': '+41 44 416 43 01'}], 'facility': 'Stadtspital Zürich Triemli', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Bruno Fuchs, Prof.', 'role': 'CONTACT', 'email': 'bruno.fuchs@ksw.ch', 'phone': '+41 52 266 25 33'}, {'name': 'Larissa Slater', 'role': 'CONTACT', 'email': 'larissa.slater@ksw.ch', 'phone': '+41 52 266 24 88'}], 'overallOfficials': [{'name': 'Bruno Fuchs, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SwissSarcomaNetwork'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Winterthur KSW', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swiss Sarcoma Network', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}