Genotoxicity Assessment for Patients Undergoing Radiation Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Rochester
Sponsor:
Information provided by (Responsible Party):
Yuhchyau Chen, University of Rochester
ClinicalTrials.gov Identifier:
NCT00167427
First received: September 9, 2005
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition
Neoplasms

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.

  Eligibility

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

Criteria

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
  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 ClinicalTrials.gov identifier: NCT00167427

Contacts
Contact: Therese Smudzin, BS 585-275-7848 therese_smudzin@urmc.rochester.edu
Contact: Yuhchyau Chen, MD, Ph.D 585-275-5623 yuhchyau_chen@urmc.rochester.edu

Locations
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
Investigators
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
ClinicalTrials.gov Identifier: NCT00167427     History of Changes
Other Study ID Numbers: URCC 3705, 1 U19 AI067733-01
Study First Received: September 9, 2005
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014