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Genotoxicity Assessment for Patients Receiving Large Field Irradiation


N/A
18 Years
N/A
Open (Enrolling)
Both
Neoplasms

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Trial Information

Genotoxicity Assessment for Patients Receiving Large Field Irradiation


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Measure the Change in MN-RET in the blood

Outcome Time Frame:

Baseline and 1 day

Safety Issue:

No

Principal Investigator

Yuhchyau Chen, MD, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universtiy of Rochester, Dept of Radiation Oncology

Authority:

United States: Institutional Review Board

Study ID:

URCC 3705

NCT ID:

NCT00167427

Start Date:

April 2006

Completion Date:

October 2018

Related Keywords:

  • Neoplasms
  • Neoplasms

Name

Location

University of Rochester, Dept. Radiation OncologyRochester, New York  14642