Evaluation of Immunological Changes in patients treated with CyberKnife® radiosurgery and Radiotherapy
Not Applicable
Completed
- Conditions
- Health Condition 1: null- 1. Patient with histologically confirmed carcinoma.2. Patients planned to undergo CyberKnife Radiosurgery or Radiotherapy and available during pre & post treatment for blood sample collection.
- Registration Number
- CTRI/2011/06/001800
- Lead Sponsor
- Health Care Global Enterprises Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Histologically confirmed carcinoma.
Adult (18 years old or older).
Willingness to give informed consent.
Patients planned to undergo CyberKnife Radiosurgery or Radiotherapy and available during pre & post treatment for blood sample collection.
Exclusion Criteria
HIV
Autoimmune disorders
Uncontrolled diabetes
Have any other condition, which the attending physician or staff considers a contraindication to the subjects participation in the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunological & inflammatory Response.The blood samples will be assessed for the following parameters viz. CD4 CD16 CD25 CD56 CD83 CD86 CD107A GRANZYME IL10 IL12 INF tumour markers.Timepoint: In 50 patients undergoing CyberKnife the blood samples are collected prior to first fraction of CyberKnife and within 48 hours of last fraction of CyberKnife. In 50 patients undergoing Radiotherapy, the blood samples are collected before start of radiotherapy and on 10th day of radiotherapy. The blood sample collection between 21st-45th day 90th-120th day and 180th-210th day of start of treatment in either arm are optional.
- Secondary Outcome Measures
Name Time Method To correlate marker values with survival outcomes.Timepoint: To correlate marker values with survival outcomes such as 6 months response, disease <br/ ><br>free survival and overall survival. <br/ ><br>