Genotoxicity Assessment for Patients Undergoing Radiation Treatment

Genotoxicity Assessment for Patients Receiving Large Field Irradiation

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms

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 Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

• Study Contact: Name: Therese Smudzin, BS; Phone Number: 585-275-7848; Email: therese_smudzin@urmc.rochester.edu
• Study Contact Backup: Name: Yuhchyau Chen, MD, Ph.D; Phone Number: 585-275-5623; Email: yuhchyau_chen@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester, Dept. Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients that are scheduled to begin radiotherapy to the large-field chest region

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure the Change in MN-RET in the blood	Baseline and 1 day

Collaborators and Investigators

• Sponsor: Yuhchyau Chen
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Yuhchyau Chen, MD, Ph.D, Universtiy of Rochester, Dept of Radiation Oncology

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): February 23, 2024
• Study Completion (Actual): February 23, 2024

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimated): September 14, 2005

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: URCC 3705; 1U19AI067733-01 (U.S. NIH Grant/Contract)