Genotoxicity Assessment for Patients Undergoing Radiation Treatment

This study is currently recruiting participants.
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

Resource links provided by NLM:


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
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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 20, 2014