Mr. John Easton
5841 S. Maryland Ave., MC 6063
Chicago, IL 60637
Phone: 773-702-3171
Email: jeaston@mcis.bsd.uchicago.edu
Projects are approved by an IRB located at: University of Chicago.
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: M1264-01
Number of Human Subjects Projects reported: 1
Project Identifier: UCHI-86-DEFG0286ER60408
Project Title:
Correlation of Chromosome Patterns in Leukemic Cells of Patients with Exposure to Chemicals and/or Radiation
Principal Investigator:
Dr. Janet D. Rowley
Project started in: 1986
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Human subjects were used only as a source of material. The funds received under this grant are used entirely for the cytogenetic and molecular analysis of this material.
Total Funding: $1,237,741
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: July 26, 1996
IRB Approval Number: 6609
Number of Human Subjects who participated in this project/protocol during
07/26/95 - 07/26/96: 150
Type of Human Subjects Involvement:
A. Objectives
To identify recurring chromosome abnormalities in human acute leukemia that occurs after prior treatment with radiation and/or chemotherapy for a prior malignant disease. To clone the translocation breakpoints in selected recurring translocations. To determine the function of the affected genes in normal cells and their altered function in leukemic cells.
B. Methodology
Samples of tissues involved with leukemia, including peripheral blood, bone marrow, lymph nodes and spleen, are obtained by the patient's physician and are sent for cytogenetic and molecular genetic analysis. At the time we received the sample, we do not know whether the patient will be part of our research program.
We process part of the sample for cytogenetic analysis using standard techniques. We also often use some of the cells for specialized studies including fluorescence in situ hybridization (FISH). If there are sufficient cells, some are frozen in dimehylsulphoxide (DMSO) and stored in liquid nitrogen for future molecular analysis. After we analyze the karyotype and receive the pertinent clinical information, we determine which patients should be included.
C. Ionizing Radiation, Radioactive Substances, or Chemical Substances
No chemical or radioactive substances or ionizing radiation is administered to individuals as part of this research.
I have no responsibility for the medical treatment of patients. The attending physicians obtain the diagnostic x-rays that are appropriate and then recommend the treatment that is indicated for patients diagnosis and stage of the disease. This can include radiation and/or chemotherapy. The treatment varies for different patients.
D. Involvement of Human Subjects
As noted in section C, the treatment is tailored to the patient's disease. In our analysis of samples from the patients, especially in the molecular diagnostics laboratory, we may use DNA probes labelled with an isotope of phosphorous (32P) to determine whether a patient has a chromosome rearrangement that can be detected with DNA probes.
The project primarily uses samples obtained for clinical evaluation for this research project. On occasion, if we do not have any material for a particularly important research question, we might ask another research laboratory that may also have received a sample whether they have extra material they could share with us.
We are not involved in vitro fertilization or genetic engineering. We do culture leukemic cells for two to three days to obtain mitotic cells.
We provide reports on the patients to the referring physician. The cytogenetic reports are kept in file cabinets in a locked room. Because all of the samples are obtained by the physician to enable him/her to provide the best treatment for the patient, there is no harm to the patient.
When patients are reported on in scientific papers, they are identified only by case numbers.