Dr. James
Ruttenber
Dep't Preventive Medicine/Biometrics
4200 E. Ninth Ave.
Campus Box C-245
Denver, CO 80262-
Phone: 303-315-5627
Fax: 303-315-3183
E-mail: jim.ruttenber@uchsc.edu
Number of Human Subjects projects reported: 1
Project Identifier:
UCHSC-92-U50/CCU808715
Project Title:
"Epidemiologic Evaluation of Childhood Leukemia and Paternal Exposure to Ionizing Radiation"
Principal Investigator: Dr. A. James Ruttenber, University of Colorado Health Sciences Center
Project started in: 1992
This project ended in fiscal year 1999.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 02/12/99
IRB approval number: 94-033
Explanation of IRB approval:
Overall project reviewed by CDC IRB (approval renewal 2/12/99) and by University of Colorado IRB. Some case and control subjects are enrolled from Atlanta Metro area. This portion of project is conducted by Emory University.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 650
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
An Epidemiologic Study of the Relation Between Maternal and Paternal Preconception Exposure to Ionizing Radiation and Childhood Leukemia
A. Objectives.
This study is designed to determine whether preconception gonadal doses from ionizing radiation are higher in the parents of children with leukemia than in parents of healthy children. This hypothesis is based on previous study findings that, compared with control groups, children with leukemia were more likely to have fathers who worked at the Sellafield nuclear facility in Great Britain and to have received higher doses of ionizing radiation prior to the conception of the child.
B. Methods
This is conducted as a case-control study. Cases will be children with leukemia and controls will be children without leukemia selected at random from the same population as the cases. In addition, the next older sibling will be used in a second control group. The main exposure of interest, paternal and maternal gonadal absorbed doses from ionizing radiation during the six-month time period before conception, will be quantified by taking detailed histories from the parents about medical, occupational, and environmental exposures that they had during the time period of interest. Gonadal doses will be estimated from the documentation of each exposure.
By calculating the doses of ionizing radiation each parent received, we can compute odds ratios and confidence intervals for paternal and maternal doses separately and combined. These findings will clarify whether the previously determined risks can be detected in other populations with similar exposures. Consistency in the results of this study with those of the study in Great Britain would have a major impact on current medical practice and occupational exposure standards. If this study does not detect an elevated risk for leukemia, it will be unlikely that preconception gonadal doses from ionizing radiation that are received by the general public are related to childhood leukemia.
C. Radiation exposures
Study participants are not exposed to any radioactive substances or ionizing radiation during the course or the study.
D. Involvement of Human Subjects
1. Only an in-person interview with case or control subjects parents are conducted. The case or control subjects do not actively participate in the study.
2. The only risks are those associated with the psychological discomfort of parents of cases revealing exposures that may later be associated with their child's disease.
3. All personnel sign security agreements not to discuss identifying information. All computer files are password protected. All hard copy files are maintained in locked file cabinets.