An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial (TOSS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00384735|
Recruitment Status : Unknown
Verified November 2014 by Dr. Ajay Puri, Terry Fox Foundation.
Recruitment status was: Active, not recruiting
First Posted : October 6, 2006
Last Update Posted : November 14, 2014
|Condition or disease||Phase|
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 Type :||Observational|
|Actual Enrollment :||500 participants|
|Official Title:||An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial|
|Study Start Date :||January 2006|
|Primary Completion Date :||June 2010|
|Estimated Study Completion Date :||June 2015|
Intensive - 3 monthly follow up
Intensive - 6 monthly follow up
Cost Effective - 3 monthly follow up
Cost Effective - 6 monthly follow up
- Overall Survival [ Time Frame: Minimum 2 years ]
- Disease free survival [ Time Frame: Minimum 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384735
|Tata Memorial Hospital|
|Mumbai, Maharashtra, India, 400012|
|Principal Investigator:||Dr. Ajay Puri||Tata Memorial Hospital|