Genotoxicity Assessment for Patients Undergoing Radiation Treatment
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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 |
- 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) |
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 |
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
- 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| 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 |
| 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 | |
| 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, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013