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Completed

NCT Number: NCT00167427

Genotoxicity Assessment for Patients Undergoing Radiation Treatment

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester, Dept. Radiation Oncology

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Measure the Change in MN-RET in the blood

    Time frame: Baseline and 1 day

Sponsors and collaborators

Lead sponsor

Yuhchyau Chen

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Genotoxicity Assessment for Patients Receiving Large Field Irradiation

Important dates

Study start
2006
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2005
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.