LeukemiaNCT00897078
Study of Metabolic Syndrome in Young Patients Who Are Acute Lymphoblastic Leukemia Survivors and Their Healthy Siblings
An observational study of Leukemia, run by Vanderbilt University at 2 sites in United States.
Trial summary
RATIONALE: Gathering information about metabolic syndrome from young patients who have survived acute lymphoblastic leukemia (ALL) may help doctors learn more about the disease. PURPOSE: This phase I trial is studying the metabolic syndrome in young patients who have survived acute lymphoblastic leukemia and in… Read more about this study
- Who is it for?
- Ages 8 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Leukemia
- What is being tested?
- laboratory biomarker analysis, medical chart review and metabolic assessment
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Oct 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 8 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: A minimum target accrual at each institution is 25 subjects for each treatment modality and 25 siblings, for a total of 75 study participants at VCH. An attempt will be made to approach equal numbers of male and female survivors.
Who may be able to join
- DISEASE CHARACTERISTICS:
- Meets one of the following eligibility criteria:
- Childhood acute lymphoblastic leukemia survivor
- Less than 22 years old at diagnosis
- Treated from 1990-2007 at one of the following locations:
- Fred Hutchinson Cancer Research Center and/or Children's Hospital and Regional Medical Center in Seattle, WA
Show all 20Show fewer
- Vanderbilt Children's Hospital in Nashville, TN
- Meets 1 of the following treatment criteria:
- Completed conventional therapy ≥ 11 months ago and in first complete remission
- Received an allogeneic hematopoietic cell transplantation ≥ 11 months ago and in complete remission
- No evidence of recurrent disease
- Healthy volunteer
- Full sibling of enrolled cancer survivor
- Age 8-21 (if more than 1 eligible sibling, sibling of closest age is preferred)
- No history of cancer
- PATIENT CHARACTERISTICS:
- Able to speak, read, and write English
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No active treatment for graft-vs-host disease
Who cannot join
- Lack of ability to speak, read, and write English
- Active treatment for graft versus host disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Health Effects After Leukemia (HEAL) Research Study
RATIONALE: Gathering information about metabolic syndrome from young patients who have survived acute lymphoblastic leukemia (ALL) may help doctors learn more about the disease.
PURPOSE: This phase I trial is studying the metabolic syndrome in young patients who have survived acute lymphoblastic leukemia and in healthy sibling volunteers.
Read the detailed description
OBJECTIVES:
- Determine the prevalence of the metabolic syndrome (MS) and its component traits (i.e., obesity, hypertension, dyslipidemia, and insulin resistance) in survivors of childhood acute lymphoblastic leukemia and in healthy sibling volunteers.
- Identify host- and treatment-related risk factors for MS.
OUTLINE: This is a multicenter study.
Patients' medical charts are reviewed and patients undergo anthropometric measuring (height and weight for BMI calculation and waist and hip circumferences) and blood pressure testing. Patients also complete questionnaires on their physical activity, diet, and family history over 30-45 minutes. Blood is collected to measure cytokines (e.g., adiponectin, leptin, interleukin-6, and C-reactive protein), fasting glucose, and fasting insulin.
Healthy volunteers undergo anthropometric measuring and blood pressure testing (if they are seen in the clinic). They also complete a baseline medical history and questionnaires on their physical activity and diet.
- Conditions
- Leukemia
- Being tested
- laboratory biomarker analysis, medical chart review, metabolic assessment, questionnaire administration, assessment of therapy complications
- Keywords
- cancer survivor, healthy, no evidence of disease, long-term effects secondary to cancer therapy in children, childhood acute lymphoblastic leukemia in remission
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Also called none noted
medical chart reviewOther
Also called none noted
metabolic assessmentOther
Also called none noted
questionnaire administrationOther
Also called none noted
will be obtained at a single clinic visit
assessment of therapy complicationsProcedure or surgery
Also called none noted
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers
Measured: 2009-2011
Host- and treatment-related risk factors for MS
Measured: 2009-2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jill Simmons, Vanderbilt University
- Investigators
- Jill Simmons, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897078
- Sponsor's protocol ID
- CDR0000635797
- Other IDs
- VU-VICC-PED-0888, 081208
- Status last verified
- Jun 2013
- First submitted
- 9 May 2009
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects After Leukemia (HEAL) Research Study
- ClinicalTrials.gov ID
- NCT00897078
- Acronym / sponsor ID
- CDR0000635797
- Conditions
- Leukemia
- Keywords
- cancer survivor, healthy, no evidence of disease, long-term effects secondary to cancer therapy in children, childhood acute lymphoblastic leukemia in remission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 12 May 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 metabolic syndrome from young patients who have survived acute lymphoblastic leukemia (ALL) may help doctors learn more about the disease.
PURPOSE: This phase I trial is studying the metabolic syndrome in young patients who have survived acute lymphoblastic leukemia and in healthy sibling volunteers.
Detailed description
OBJECTIVES:
- Determine the prevalence of the metabolic syndrome (MS) and its component traits (i.e., obesity, hypertension, dyslipidemia, and insulin resistance) in survivors of childhood acute lymphoblastic leukemia and in healthy sibling volunteers.
- Identify host- and treatment-related risk factors for MS.
OUTLINE: This is a multicenter study.
Patients' medical charts are reviewed and patients undergo anthropometric measuring (height and weight for BMI calculation and waist and hip circumferences) and blood pressure testing. Patients also complete questionnaires on their physical activity, diet, and family history over 30-45 minutes. Blood is collected to measure cytokines (e.g., adiponectin, leptin, interleukin-6, and C-reactive protein), fasting glucose, and fasting insulin.
Healthy volunteers undergo anthropometric measuring and blood pressure testing (if they are seen in the clinic). They also complete a baseline medical history and questionnaires on their physical activity and diet.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- A minimum target accrual at each institution is 25 subjects for each treatment modality and 25 siblings, for a total of 75 study participants at VCH. An attempt will be made to approach equal numbers of male and female survivors.
Key inclusion criteria (20 listed)
- Meets one of the following eligibility criteria:
- Able to speak, read, and write English
- See Disease Characteristics
- No active treatment for graft-vs-host disease
Key exclusion criteria (2 listed)
- Lack of ability to speak, read, and write English
- Active treatment for graft versus host disease
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 |
|---|---|---|
| laboratory biomarker analysisAlso: none noted | Other | – |
| medical chart reviewAlso: none noted | Other | – |
| metabolic assessmentAlso: none noted | Other | – |
| questionnaire administrationAlso: none notedwill be obtained at a single clinic visit | Other | – |
| assessment of therapy complicationsAlso: none noted | Procedure or surgery | – |
Primary outcome
Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers
Time frame: 2009-2011
Host- and treatment-related risk factors for MS
Time frame: 2009-2011
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 13 Jun 2013.
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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.
Jill Simmons, MD principal investigator
Vanderbilt-Ingram Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by Vanderbilt University at 2 sites 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 20 inclusion and 2 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 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers (time frame: 2009-2011). 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 13 Jun 2013.