Childhood Cancer Survivors Treated With Abdominal Radiation Clinical Trial
Official title:
Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal Irradiation: A Pilot Study
| NCT number | NCT02248779 |
| Other study ID # | 14-202 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 22, 2014 |
| Est. completion date | October 9, 2019 |
| Verified date | October 2019 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to better understand the risk factors and causes of diabetes in people who received radiation to the abdomen as children. The investigators hope this information will allow them to improve how they screen people at risk for diabetes and how they treat patients in the future.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | October 9, 2019 |
| Est. primary completion date | October 9, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Diagnosis of childhood cancer between 0-21 years of age - Prior treatment with abdominal radiation at MSKCC - Two or more years from completion of therapy - Records of cancer diagnosis and treatment (including radiation records) available Exclusion Criteria: - Known diagnosis of diabetes - Previous treatment with any radiation impacting the brain (cranial radiation, craniospinal radiation, total body irradiation) - Neurocognitive deficits that impair ability to give informed consent or assent - Patients predicted to have difficult intravenous access, who will likely require multiple venipuncture attempts |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | characterize ß cell function | we will be able to estimate the proportion of patients with abnormalities of insulin sensitivity or ß cell function, as assessed by the OGTT, to within ± 0.14. | 2 years | |
| Primary | insulin sensitivity | we will be able to estimate the proportion of patients with abnormalities of insulin sensitivity or ß cell function, as assessed by the OGTT, to within ± 0.14. | 2 years |