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Genotoxicity Assessment for Patients Undergoing Radiation Treatment

Genotoxicity Assessment for Patients Receiving Large Field Irradiation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00167427
Enrollment
47
Registered
2005-09-14
Start date
2006-04-30
Completion date
2024-02-23
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

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.

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.

Interventions

None listed

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
Yuhchyau Chen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Measure the Change in MN-RET in the bloodBaseline and 1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026