| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10021 |
| Conditions: |
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Leukemia - Hodgkin's Lymphoma - Non-Hodgkin's Lymphoma - Myelodysplastic Syndrome |
| Purpose: |
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The purpose of this study is to better understand why some women who survived cancer or a
related illness later develop diabetes, problems with their cholesterol, or other problems
that may lead to heart disease. Because these problems may be related to treatment with
total body irradiation and a stem cell transplant, the investigators will compare the rates
of obesity, cholesterol problems, and diabetes between women who were treated with total
body irradiation and a stem cell transplant and women who were not.
The amount and location of fat stores in the abdomen is more important than overall weight
or total body fat in the development of diabetes and cholesterol problems. In general, fat
can be stored in several areas in the abdomen: around the organs (visceral fat), under the
skin (subcutaneous fat), and in the liver (liver fat). People with higher amounts of fat
around the organs (visceral fat), even those with a normal weight, are more likely to become
diabetic or have high cholesterol. The amount of fat in each of these areas can be measured
with an abdominal magnetic resonance imaging (MRI).
In this study, the investigators will use blood tests, height, weight, waist circumference,
blood pressure measurements, and an abdominal MRI to evaluate for several risk factors of
heart disease, including cholesterol problems, diabetes and pre-diabetes, elevated blood
pressure, and increased abdominal fat.
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| Study summary: |
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We will enroll 60 female participants in this study. From the population of interest, female
cancer survivors (or women treated for a related illness) who were treated with TBI prior to
a SCT, we will enroll 30 participants, 10 from each of the following cancer groups: acute
lymphoblastic leukemia, acute myeloid leukemia, and chronic myeloid leukemia. We are
interested in determining the outcomes in adult survivors who have completed their growth by
the time of study and yet are younger than the age when most women generally begin to
develop insulin resistance or dyslipidemia in the general population. For this reason, we
will enroll women who are 18 - 49 years of age at the time of study. |
| Criteria: |
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Inclusion Criteria:
Target population
- Females 18 - 49 years of age at time of study
- Previous diagnosis of ALL, AML, CML, CLL, Hodgkin's lymphoma, Non-hodgkin's lymphoma,
aplastic anemia, and myelodysplastic syndrome
- Previously treated with TBI (1200 - 1500 cGy) prior to SCT
- Free of cancer
- Two years or more from completion of cancer therapy
- Able and willing to give informed consent
Comparison group
- Females 18 - 49 years of age at time of study
- Previous diagnosis of ALL, AML, CML CLL, Hodgkin's lymphoma, Non-hodgkin's lymphoma,
aplastic anemia, and myelodysplastic syndrome
- Free of cancer
- Two years or more from completion of cancer therapy
- Able and willing to give informed consent
Exclusion Criteria:
Target population
- Pregnant at time of study
- Previous cranial radiotherapy (other than TBI)
- Second primary malignancy (other than non-melanoma skin cancer)
- Any patient who has received glucocorticoids or tacrolimus within 60 days prior to
the study
- Currently on a medication for diabetes mellitus or dyslipidemia
- Patients with a creatinine > 1.5 mg/dL or biopsy-proven chronic active hepatitis
- Contraindication to an MRI
Comparison group
- pregnant at time of study
- Previous cranial radiotherapy
- Second primary malignancy (other than non-melanoma skin cancer)
- Any patient who has received glucocorticoids or tacrolimus within 60 days prior to
the study
- Currently on a medication for diabetes mellitus or dyslipidemia
- Patients with a creatinine > 1.5 or biopsy-proven chronic active hepatitis
- Contraindication to an MRI |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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