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Evaluation of Immunological Changes in patients treated with CyberKnife® radiosurgery and Radiotherapy

Evaluation of Immunological Changes in patients treated with CyberKnife® radiosurgery and Radiotherapy ? A prospective and comparative study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2011/06/001800
Enrollment
100
Registered
2011-06-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Intervention1: CyberKnife Radiosurgery: CyberKnife is a robotic stereotactic machine which combines potent dose fractionation, careful target definition, motion control (four dimensional therapy), ima
patients undergoing radiotherapy will also be enrolled in the study.

Sponsors

Health Care Global Enterprises Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To correlate marker values with survival outcomes.Timepoint: To correlate marker values with survival outcomes such as 6 months response, disease free survival and overall survival.—

Countries

India

Contacts

Public ContactDr ChennaKeshava
raswamy2002@yahoo.com08040206000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026