Genotoxicity Assessment for Patients Undergoing Radiation Treatment

Yuhchyau Chen

Status: Completed

Conditions: Neoplasms

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00167427

1U19AI067733-01 (U.S. NIH Grant/Contract)

URCC 3705

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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