Childhood Cancer Survivors Treated With Abdominal RadiationNCT02248779
Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal Irradiation
An observational study of Childhood Cancer Survivors Treated With Abdominal Radiation, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Childhood Cancer Survivors Treated With Abdominal Radiation
- Type of treatment
- Pill or oral medicine
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2014to 9 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Childhood cancer survivors followed by the Pediatric Long-Term Follow-Up Program or Adult Long-Term Follow-Up Program will be recruited for the current study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal Irradiation: A Pilot Study
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.
- Keywords
- Diabetes Risk, 14-202
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| treated < 20 years prior to study enrollment | The following information will be gathered: A. Height, weight, waist circumference, blood pressure B. Oral glucose tolerance testing (OGTT) where in participants will ingest a standard oral glucose load (75 grams) in liquid formulation after an overnight fast. Blood samples for glucose and insulin concentrations will be taken at 0, 30, 60, 90, and 120 minutes post-glucose load. C. Glutamic acid decarboxylase (GAD), islet cell (ICA-512), and insulin autoantibody (IAA) titers as well as serum adiponectin and hemoglobin A1c. All enrolled patients will have a discussion with an LTFU doctor regarding the results of testing. Counseling and referral to a specialist will be provided if indicated. | |
| treated ≥ 20 years prior to study enrollment | The following information will be gathered: A. Height, weight, waist circumference, blood pressure B. Oral glucose tolerance testing (OGTT) where in participants will ingest a standard oral glucose load (75 grams) in liquid formulation after an overnight fast. Blood samples for glucose and insulin concentrations will be taken at 0, 30, 60, 90, and 120 minutes post-glucose load. C. Glutamic acid decarboxylase (GAD), islet cell (ICA-512), and insulin autoantibody (IAA) titers as well as serum adiponectin and hemoglobin A1c. All enrolled patients will have a discussion with an LTFU doctor regarding the results of testing. Counseling and referral to a specialist will be provided if indicated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
characterize β cell function
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.
Measured: 2 years
insulin sensitivity
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study start22 Sep 2014
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Cancer Survivors Treated With Abdominal RadiationStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle N. Friedman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248779
- Sponsor's protocol ID
- 14-202
- Status last verified
- Oct 2019
- First submitted
- 22 Sep 2014
- Last updated
- 15 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal Irradiation: A Pilot Study
- ClinicalTrials.gov ID
- NCT02248779
- Acronym / sponsor ID
- 14-202
- Keywords
- Diabetes Risk, 14-202
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 22 Sep 2014 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treated < 20 years prior to study enrollment | – | –The following information will be gathered: A. Height, weight, waist circumference, blood pressure B. Oral glucose tolerance testing (OGTT) where in participants will ingest a standard oral glucose load (75 grams) in liquid formulation after an overnight fast. Blood samples for glucose and insulin concentrations will be taken at 0, 30, 60, 90, and 120 minutes post-glucose load. C. Glutamic acid decarboxylase (GAD), islet cell (ICA-512), and insulin autoantibody (IAA) titers as well as serum adiponectin and hemoglobin A1c. All enrolled patients will have a discussion with an LTFU doctor regarding the results of testing. Counseling and referral to a specialist will be provided if indicated. |
| treated ≥ 20 years prior to study enrollment | – | –The following information will be gathered: A. Height, weight, waist circumference, blood pressure B. Oral glucose tolerance testing (OGTT) where in participants will ingest a standard oral glucose load (75 grams) in liquid formulation after an overnight fast. Blood samples for glucose and insulin concentrations will be taken at 0, 30, 60, 90, and 120 minutes post-glucose load. C. Glutamic acid decarboxylase (GAD), islet cell (ICA-512), and insulin autoantibody (IAA) titers as well as serum adiponectin and hemoglobin A1c. All enrolled patients will have a discussion with an LTFU doctor regarding the results of testing. Counseling and referral to a specialist will be provided if indicated. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Childhood cancer survivors followed by the Pediatric Long-Term Follow-Up Program or Adult Long-Term Follow-Up Program will be recruited for the current study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle N. Friedman, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cancer Survivors Treated With Abdominal Radiation, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characterize β cell function (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.