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OpenTrials
Completed

NCT Number: NCT02248779

Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal Irradiation

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.

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Key information

Conditions

Childhood Cancer Survivors Treated With Abdominal Radiation

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. characterize β cell function

    Time frame: 2 years

    we will be able to estimate the proportion of patients with abnormalities of insulin sensitivity or β cell function, as assessed by the OGTT, to within ± 0.14.

  2. insulin sensitivity

    Time frame: 2 years

    we will be able to estimate the proportion of patients with abnormalities of insulin sensitivity or β cell function, as assessed by the OGTT, to within ± 0.14.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal Irradiation: A Pilot Study

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2014
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.