Brain and Central Nervous System TumorsNCT00920738
Metabolic Syndrome in Childhood Cancer Survivors
An observational study of Brain and Central Nervous System Tumors and Leukemia, run by University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood cancer may help doctors learn more about the disease. PURPOSE: This clinical trial is studying metabolic syndrome in survivors of childhood cancer and in their healthy sisters and brothers. Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain and Central Nervous System Tumors, Leukemia, Lymphoma
- What is being tested?
- metabolic assessment and questionnaire administration
- How many people
- 512 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jun 2011
- 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 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The childhood cancer survivor (CCS) subjects for this study will be selected from Pediatric Oncology databases at the University of Minnesota Medical Center and Children"s Hospitals and Clinics of Minneapolis and St. Paul as described previously. CCS will complete a comprehensive evaluation in the Masonic Clinical Research Unit (MCRU) over a 2 day time period. The comparative data on normal children and adolescents will be obtained from healthy siblings frequency matched by age and gender and who will be evaluated in a manner similar to the CCS.
Who may be able to join
- Subjects must be survivors of childhood cancer, treated at Fairview-University Medical Center or Children's Hospitals and Clinics of Minneapolis and St Paul or siblings of survivors.
- Subjects will be 9-17 years old at the time of their visit.
- Subjects who are cancer survivors must have survived childhood cancer for a minimum of 5 years and be in remission.
Who cannot join
- Eligibility will not be restricted by race or sex.
- Any women currently pregnant will not be eligible, but may participate 3 or more months after the end of her pregnancy if the study is still ongoing.
- Subjects who underwent hematopoietic cell transplant (HCT) are not eligible for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Children's Hospital - Fairview
Minneapolis, Minnesota, 55455
About this study
RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood cancer may help doctors learn more about the disease.
PURPOSE: This clinical trial is studying metabolic syndrome in survivors of childhood cancer and in their healthy sisters and brothers.
Read the detailed description
OBJECTIVES:
Primary
- Determine the manifestations of metabolic syndrome (MS) in children and adolescents who are survivors of childhood cancer (CCS).
- Compare the prevalence of MS in CCS to that of matched healthy siblings of similar age and gender.
- Evaluate insulin resistance (as measured by the euglycemic insulin clamp) in CCS and compare to that of healthy siblings of similar age and gender.
- Assess the extent to which prevalent obesity and insulin resistance are correlated with other factors that have been identified in the causal pathway associated with the development of the MS that may be altered in the CCS ( e.g., growth-hormone secretion, adipokines [adiponectin, leptin], inflammatory mediators [e.g., interleukin-6], tumor necrosis factor-α, and C-reactive protein).
- Obtain dietary and physical activity assessments of CCS and healthy siblings.
Secondary
- Explore demographic (age at treatment, sex-specific differences) and treatment-related factors (exposures and dose-related associations with chemotherapeutic agents, radiation, steroids) as potential correlates with insulin resistance, vascular function, and MS in CCS.
OUTLINE: Patients undergo a comprehensive medical examination including current and past medical history, family history, review of prescription medications, a physical examination including a body and visceral-fat assessment, and anthropometric (DEXA and bone-age x-ray) and blood pressure measurement. Blood samples are collected to measure growth hormone, adipokines (adiponectin, leptin), cytokines (IL-6 and CRP), fasting insulin, fasting glucose, lipids, oxidized LDL, hypothalami-pituitary-gonadal function (estrogen, FSH, LH, testosterone), and thyroid function (free T4 and TSH). Patients also complete questionnaires on dietary intake and physical activity.
Healthy siblings undergo a complete medical examination as patients do, including blood samples collection and questionnaire administration.
- Being tested
- metabolic assessment, questionnaire administration
- Keywords
- metabolic syndrome, cancer survivor, childhood soft tissue sarcoma, unspecified childhood solid tumor, protocol specific, childhood acute lymphoblastic leukemia, childhood chronic myelogenous leukemia, childhood Hodgkin lymphoma, childhood non-Hodgkin lymphoma, childhood acute myeloid leukemia/other myeloid malignancies, chronic lymphocytic leukemia, childhood brain stem glioma, childhood cerebellar astrocytoma, childhood cerebral astrocytoma/malignant glioma, childhood choroid plexus tumor, childhood craniopharyngioma, childhood embryonal tumor, childhood ependymoma, childhood oligodendroglioma, childhood pineal parenchymal tumor, childhood mixed glioma
- Medical subject headings
- Central Nervous System Neoplasms, Leukemia, Lymphoma, Metabolic Syndrome, Sarcoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metabolic assessmentOther
Physical examination, medical history, blood pressure, anthropometrics, laboratory studies and other procedures (body composition, bone density, growth hormone, vascular, functional mobility, body fat assessments, etc).
questionnaire administrationOther
Also called MAQA, AQA
Dietary habits will be evaluated using the Youth/ Adolescent Questionnaire (YAQ)and the Modifiable Activity Questionnaire for Adolescents (MAQA) will be used to assess participation in leisure time and competitive activities during the past year will be administered on Day 2.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Survivors | Subjects who are cancer survivors must have survived childhood cancer (diagnosed < or = 18 years) for a minimum of 5 years and be in remission. Receives: Other: metabolic assessment; Other: questionnaire administration | |
| Healthy Siblings of Cancer Survivor | Healthy populations similar in age and gender distribution, derived from a frequency matched control population of 350 healthy siblings. Receives: Other: metabolic assessment; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome (MS) in survivors of childhood cancer (CCS) vs controls
Measured: Day 1 and Day 2
Insulin resistance (IR) in CCS vs controls
Measured: Day 1 and Day 2
Correlation of obesity and IR to other factors associated with the development of the MS that may be altered in the CCS
Measured: Day 1 and Day 2
Dietary and a physical activity assessments of CCS vs controls
Measured: Day 1 and Day 2
Secondary outcomes (1)
Demographic and treatment-related factors as potential correlates with IR, vascular function, and MS in CCS
Measured: Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startApr 2005
- Primary completionJul 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Prospective
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Steinberger, MD, MS, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920738
- Sponsor's protocol ID
- 2003NT064
- Other IDs
- 0411M65666
- Status last verified
- Aug 2014
- First submitted
- 12 Jun 2009
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome in Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT00920738
- Acronym / sponsor ID
- 2003NT064
- Keywords
- metabolic syndrome, cancer survivor, childhood soft tissue sarcoma, unspecified childhood solid tumor, protocol specific, childhood acute lymphoblastic leukemia, childhood chronic myelogenous leukemia, childhood Hodgkin lymphoma, childhood non-Hodgkin lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Jun 2009 (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.
RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood cancer may help doctors learn more about the disease.
PURPOSE: This clinical trial is studying metabolic syndrome in survivors of childhood cancer and in their healthy sisters and brothers.
Detailed description
OBJECTIVES:
Primary
- Determine the manifestations of metabolic syndrome (MS) in children and adolescents who are survivors of childhood cancer (CCS).
- Compare the prevalence of MS in CCS to that of matched healthy siblings of similar age and gender.
- Evaluate insulin resistance (as measured by the euglycemic insulin clamp) in CCS and compare to that of healthy siblings of similar age and gender.
- Assess the extent to which prevalent obesity and insulin resistance are correlated with other factors that have been identified in the causal pathway associated with the development of the MS that may be altered in the CCS ( e.g., growth-hormone secretion, adipokines [adiponectin, leptin], inflammatory mediators [e.g., interleukin-6], tumor necrosis factor-α, and C-reactive protein).
- Obtain dietary and physical activity assessments of CCS and healthy siblings.
Secondary
- Explore demographic (age at treatment, sex-specific differences) and treatment-related factors (exposures and dose-related associations with chemotherapeutic agents, radiation, steroids) as potential correlates with insulin resistance, vascular function, and MS in CCS.
OUTLINE: Patients undergo a comprehensive medical examination including current and past medical history, family history, review of prescription medications, a physical examination including a body and visceral-fat assessment, and anthropometric (DEXA and bone-age x-ray) and blood pressure measurement. Blood samples are collected to measure growth hormone, adipokines (adiponectin, leptin), cytokines (IL-6 and CRP), fasting insulin, fasting glucose, lipids, oxidized LDL, hypothalami-pituitary-gonadal function (estrogen, FSH, LH, testosterone), and thyroid function (free T4 and TSH). Patients also complete questionnaires on dietary intake and physical activity.
Healthy siblings undergo a complete medical examination as patients do, including blood samples collection and questionnaire administration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Survivors | – | Other: metabolic assessment, Other: questionnaire administrationSubjects who are cancer survivors must have survived childhood cancer (diagnosed < or = 18 years) for a minimum of 5 years and be in remission. |
| Healthy Siblings of Cancer Survivor | – | Other: metabolic assessment, Other: questionnaire administrationHealthy populations similar in age and gender distribution, derived from a frequency matched control population of 350 healthy siblings. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The childhood cancer survivor (CCS) subjects for this study will be selected from Pediatric Oncology databases at the University of Minnesota Medical Center and Children"s Hospitals and Clinics of Minneapolis and St. Paul as described previously. CCS will complete a comprehensive evaluation in the Masonic Clinical Research Unit (MCRU) over a 2 day time period. The comparative data on normal children and adolescents will be obtained from healthy siblings frequency matched by age and gender and who will be evaluated in a manner similar to the CCS.
Key inclusion criteria (3 listed)
- Subjects must be survivors of childhood cancer, treated at Fairview-University Medical Center or Children's Hospitals and Clinics of Minneapolis and St Paul or siblings of survivors.
- Subjects will be 9-17 years old at the time of their visit.
- Subjects who are cancer survivors must have survived childhood cancer for a minimum of 5 years and be in remission.
Key exclusion criteria (3 listed)
- Eligibility will not be restricted by race or sex.
- Any women currently pregnant will not be eligible, but may participate 3 or more months after the end of her pregnancy if the study is still ongoing.
- Subjects who underwent hematopoietic cell transplant (HCT) are not eligible for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metabolic assessmentPhysical examination, medical history, blood pressure, anthropometrics, laboratory studies and other procedures (body composition, bone density, growth hormone, vascular, functional mobility, body fat assessments, etc). | Other | Cancer Survivors, Healthy Siblings of Cancer Survivor |
| questionnaire administrationAlso: MAQA, AQADietary habits will be evaluated using the Youth/ Adolescent Questionnaire (YAQ)and the Modifiable Activity Questionnaire for Adolescents (MAQA) will be used to assess participation in leisure time and competitive activities during the past year will be administered on Day 2. | Other | Cancer Survivors, Healthy Siblings of Cancer Survivor |
Primary outcome
Metabolic syndrome (MS) in survivors of childhood cancer (CCS) vs controls
Time frame: Day 1 and Day 2
Insulin resistance (IR) in CCS vs controls
Time frame: Day 1 and Day 2
Correlation of obesity and IR to other factors associated with the development of the MS that may be altered in the CCS
Time frame: Day 1 and Day 2
Dietary and a physical activity assessments of CCS vs controls
Time frame: Day 1 and Day 2
1 secondary outcome
Demographic and treatment-related factors as potential correlates with IR, vascular function, and MS in CCS
Time frame: Day 1 and Day 2
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 22 Aug 2014.
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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.
Julia Steinberger, MD, MS principal investigator
Masonic Cancer Center, University of Minnesota
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 Brain and Central Nervous System Tumors and Leukemia, run by University of Minnesota 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 3 inclusion and 3 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 22 Aug 2014. 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?
Metabolic syndrome (MS) in survivors of childhood cancer (CCS) vs controls (time frame: Day 1 and Day 2). The study lists 4 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 22 Aug 2014.