Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-06 @ 8:30 PM
Study NCT ID:
NCT00384735
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2006-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D001859', 'term': 'Bone Neoplasms'}, {'id': 'D012983', 'term': 'Soft Tissue Neoplasms'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2006-10-04', 'studyFirstSubmitQcDate': '2006-10-04', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Minimum 2 years'}], 'secondaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': 'Minimum 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bone tumor', 'soft tissue tumor'], 'conditions': ['Sarcoma']}, 'referencesModule': {'references': [{'pmid': '24249538', 'type': 'DERIVED', 'citation': 'Puri A, Gulia A, Hawaldar R, Ranganathan P, Badwe RA. Does intensity of surveillance affect survival after surgery for sarcomas? Results of a randomized noninferiority trial. Clin Orthop Relat Res. 2014 May;472(5):1568-75. doi: 10.1007/s11999-013-3385-9. Epub 2013 Nov 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact on overall survival of an intensive follow-up protocol (as practiced today at TMH) against a more cost effective follow-up protocol in patients operated for extremity sarcoma.', 'detailedDescription': 'Follow up studies are performed for a variety of reasons. The detection of a recurrence of the index lesion is the foundation of surveillance. Detection of other medical conditions is a secondary benefit. Psychologically, follow up testing can serve as a source of reassurance. Whether an increased frequency of follow up and the use of various expensive imaging modalities for screening and early detection of recurrence actually results in improving overall survival of patients with extremity sarcomas is a question that remains as yet unanswered. Currently followed post -operative surveillance regimes are empirical and vary widely from centre to centre. Allocation of limited health funding should be guided by evidence based recommendations rather than empirical beliefs. An ideal surveillance regime should meet the criteria of easy implementation, accuracy and cost effectiveness.\n\nIn a vast country like India where patients often travel thousands of kilometers in their search for quality medical care the frequency of routine follow up visits is as important as studying the role of expensive screening modalities while drawing up guidelines for cost effective follow up strategies.\n\nThis study, a prospective randomized controlled trial, attempts to outline guidelines regarding the role of follow up vis a vis frequency and the use of various imaging modalities for early detection of recurrence in improving overall survival of patients with extremity sarcomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients operated for primary or recurrent extremity bone \\& soft tissue sarcomas', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients operated for primary or recurrent extremity bone \\& soft tissue sarcomas.(both limb salvage and amputations)\n2. Non Metastatic at presentation.\n3. Patients reliable for follow-up.\n\nExclusion Criteria:\n\n1. Non-extremity sarcomas.\n2. Metastatic at presentation\n3. Patients unreliable for follow up.'}, 'identificationModule': {'nctId': 'NCT00384735', 'acronym': 'TOSS', 'briefTitle': 'An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Terry Fox Foundation'}, 'officialTitle': 'An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'TOSS'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1A', 'description': 'Intensive - 3 monthly follow up'}, {'label': '1B', 'description': 'Intensive - 6 monthly follow up'}, {'label': 'IIA', 'description': 'Cost Effective - 3 monthly follow up'}, {'label': 'IIB', 'description': 'Cost Effective - 6 monthly follow up'}]}, 'contactsLocationsModule': {'locations': [{'zip': '400012', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Tata Memorial Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}], 'overallOfficials': [{'name': 'Dr. Ajay Puri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tata Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Terry Fox Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tata Memorial Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. Ajay Puri', 'investigatorAffiliation': 'Terry Fox Foundation'}}}}