Genotoxicity Assessment for Patients Undergoing Radiation Treatment

Completed

• Conditions: Neoplasms

• Registration Number: NCT00167427
• Lead Sponsor: Yuhchyau Chen

Brief Summary

The purpose of the research study is to evaluate an automated, laser-based technique for measuring DNA damage caused by radiation during cancer treatment in immature red blood cells.

Detailed Description

Correlative studies: analysis of RT effect on genotoxicity by assessing cytogenetic changes (dicentrics), micronucleated lymphocytes (MN-lymph), and micronucleated reticulocytes (MN-RET) using peripheral blood of patients receiving radiation.

i) document the kinetics by which radiation-induced MN-RET enter the peripheral blood stream.

ii) benchmark the MN-RET endpoint against current gold-standard biodosimetry endpoints-dicentrics and MN-lymphocytes.

iii) measure inter-individual variation in baseline and radiation-induced MN-RET frequencies.

iv) in collaboration with several FCM-equipped laboratories, evaluate the transferability of the human MN-RET scoring assay.

Study Timeline

• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Study Start: 2006-04
• Primary Completion: 2024-02-23
• Study Completion: 2024-02-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Patients that are scheduled to begin radiotherapy to the large-field chest region are eligible if:

  • Daily radiation dose is between 1.8 and 5 Gy/day
  • Any single dimension of field size is ≥ 15 cm
  • Provision of written informed consent

or

• Or patients receiving IMRT or Tomotherapy, when low-dose radiation is spread out to the normal tissues, irrespective of daily radiation doses.
• Or patients receiving radionucleotides as part of the medical treatment (cancer or non-malignant conditions)
• Or patients who will receive diagnostic CT scans, PET/CT scans, mammograms, or diagnostic imaging requiring radionucleotides

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure the Change in MN-RET in the blood	Baseline and 1 day

Trial Locations

Locations (1)

University of Rochester, Dept. Radiation Oncology; 🇺🇸 Rochester, New York, United States