Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Genotoxicity Assessment for Patients Undergoing Radiation Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Rochester
Information provided by (Responsible Party):
Yuhchyau Chen, University of Rochester Identifier:
First received: September 9, 2005
Last updated: December 5, 2014
Last verified: December 2014

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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genotoxicity Assessment for Patients Receiving Large Field Irradiation

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Measure the Change in MN-RET in the blood [ Time Frame: Baseline and 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2006
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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


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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00167427

Contact: Therese Smudzin, BS 585-275-7848
Contact: Yuhchyau Chen, MD, Ph.D 585-275-5623

United States, New York
University of Rochester, Dept. Radiation Oncology Recruiting
Rochester, New York, United States, 14642
Contact: Yuhchayau Chen, MD, Ph.D.         
Principal Investigator: Yuhchyau Chen, MD, Ph.D         
Sponsors and Collaborators
Yuhchyau Chen
Principal Investigator: Yuhchyau Chen, MD, Ph.D Universtiy of Rochester, Dept of Radiation Oncology
  More Information

No publications provided

Responsible Party: Yuhchyau Chen, Investigatory, University of Rochester Identifier: NCT00167427     History of Changes
Other Study ID Numbers: URCC 3705, 1 U19 AI067733-01
Study First Received: September 9, 2005
Last Updated: December 5, 2014
Health Authority: United States: Institutional Review Board processed this record on March 03, 2015