Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-24 @ 1:15 AM
Study NCT ID:
NCT02380651
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2015-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Outcomes and HRQoL in Upper-extremity Sarcoma Patients After Limb Salvage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019042', 'term': 'Muscle Neoplasms'}], 'ancestors': [{'id': 'D012983', 'term': 'Soft Tissue Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D023821', 'term': 'Limb Salvage'}], 'ancestors': [{'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2015-03-01', 'studyFirstSubmitQcDate': '2015-03-01', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Visual Analogue Scale for pain', 'timeFrame': '6 months to five years', 'description': 'to assess pain'}], 'primaryOutcomes': [{'measure': 'Health-related quality of life and upper-extremity functional capability', 'timeFrame': '6 months to five years', 'description': 'To assess health-related quality of life and upper-extremity functional capability'}], 'secondaryOutcomes': [{'measure': 'Sarcoma recurrence', 'timeFrame': '6 months to five years', 'description': 'to assess sarcoma recurrence'}, {'measure': 'Quality of Life Questionnaire-Core 30', 'timeFrame': '6 months to five years', 'description': 'to assess the health-related quality of life'}, {'measure': 'the 15D health-related quality of life instrument', 'timeFrame': '6 months to five years', 'description': 'to assess the health-related quality of life'}, {'measure': 'The QuickDASH', 'timeFrame': '6 months to five years', 'description': 'to assess the upper-extremity function'}, {'measure': 'The MSTS upper extremity section', 'timeFrame': '6 months to five years', 'description': 'to assess the upper-extremity function'}, {'measure': 'The TESS upper extremity section', 'timeFrame': '6 months to five years', 'description': 'to assess the upper-extremity function'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer of Muscle']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the functional ability and health-related quality of life (HRQoL) of upper extremity sarcoma patients who have undergone limb salvage surgery.', 'detailedDescription': 'The purpose of this study is to assess the functional capabilities and health-related quality of life (HRQoL) of upper-extremity sarcoma patients who have undergone limb salvage surgery.\n\nPatient hospital records are retrospectively reviewed for demographic and clinical data.\n\nThe patient recruitment takes place at the outpatient clinic of the Comprehensive Cancer Center, Helsinki University Hospital, and Tampere University Hospital. The study includes a cross-sectional assessment at six months follow-up with five validated questionnaires. A follow-up is conducted two and five years after surgery in the outpatient clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Upper extremity sarcoma patient who underwent limb-salvage surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Upper extremity soft tissue sarcoma locating in between scapula to arm\n* No metastasis at the time of diagnosis\n* Undergone limb salvage surgery\n* A minimum of 6 months follow-up\n* Written consent\n* Age \\> 18\n\nExclusion Criteria:\n\n* Age \\<18\n* No limb-salvage surgery due to sarcoma\n* Deceased'}, 'identificationModule': {'nctId': 'NCT02380651', 'briefTitle': 'Functional Outcomes and HRQoL in Upper-extremity Sarcoma Patients After Limb Salvage', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Functional Outcomes and Health Related Quality of Life in Upper-extremity Sarcoma Patients After Limb Salvage: a Prospective Study', 'orgStudyIdInfo': {'id': '324/13/03/02/2014/1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Limb salvage', 'type': 'PROCEDURE', 'description': 'Local or free flaps'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'state': 'Uusimaa', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Erkki J Tukiainen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helsinki University Central Hospital'}, {'name': 'Carl Blomqvist, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tampere University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jussi Repo', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}