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临床试验/NCT00384735
NCT00384735已完成不适用

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

Terry Fox Foundation1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2006年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
Overall Survival

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Non-extremity sarcomas.
  • Metastatic at presentation
  • Patients unreliable for follow up.

结局指标

主要结局

Overall Survival

时间窗: Minimum 2 years

次要结局

  • Disease free survival(Minimum 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Ajay Puri

Professor

Terry Fox Foundation

研究点 (1)

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