Genotoxicity Assessment for Patients Undergoing Radiation Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2024-02-23

Brief Summary

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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

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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.

Conditions

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Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No