An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial

Conditions
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Sarcoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients operated for primary or recurrent extremity bone & soft tissue sarcomas.(both limb salvage and amputations) Non Metastatic at presentation. Patients reliable for follow-up. Exclusion Criteria: Non-extremity sarcomas. Metastatic at presentation Patients unreliable for follow up.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1A<br>Intensive - 3 monthly follow up | |
| 1B<br>Intensive - 6 monthly follow up | |
| IIA<br>Cost Effective - 3 monthly follow up | |
| IIB<br>Cost Effective - 6 monthly follow up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Minimum 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | Minimum 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone tumor, soft tissue tumor