Viewing Study NCT00384735



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Last Modification Date: 2024-10-26 @ 9:28 AM
Study NCT ID: NCT00384735
Status: COMPLETED
Last Update Posted: 2020-10-08
First Post: 2006-10-04

Brief Title: An Adequate Cost Effective Follow Up Protocol For Bone Soft Tissue Sarcomas - A Prospective Randomized Trial
Sponsor: Terry Fox Foundation
Organization: Terry Fox Foundation

Study Overview

Official Title: An Adequate Cost Effective Follow Up Protocol For Bone Soft Tissue Sarcomas - A Prospective Randomized Trial
Status: COMPLETED
Status Verified Date: 2020-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: TOSS
Brief Summary: 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
Detailed Description: 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

In 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

This 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None