Genotoxicity Assessment for Patients Undergoing Radiation Treatment
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 9, 2005 | ||||||||
| Last Updated Date | December 10, 2012 | ||||||||
| Start Date ICMJE | April 2006 | ||||||||
| Estimated Primary Completion Date | October 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Measure the Change in MN-RET in the blood [ Time Frame: Baseline and 1 day ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00167427 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Genotoxicity Assessment for Patients Undergoing Radiation Treatment | ||||||||
| Official Title ICMJE | Genotoxicity Assessment for Patients Receiving Large Field Irradiation | ||||||||
| Brief Summary | 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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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients that are scheduled to begin radiotherapy to the large-field chest region |
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| Condition ICMJE | Neoplasms | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 120 | ||||||||
| Estimated Completion Date | October 2018 | ||||||||
| Estimated Primary Completion Date | October 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
or
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00167427 | ||||||||
| Other Study ID Numbers ICMJE | URCC 3705, 1 U19 AI067733-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Yuhchyau Chen, University of Rochester | ||||||||
| Study Sponsor ICMJE | Yuhchyau Chen | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Rochester | ||||||||
| Verification Date | December 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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