Acute Lymphoblastic LeukemiaNCT01688752
Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia
An observational study of Acute Lymphoblastic Leukemia, run by University of Minnesota.
Trial summary
This is a prospective cohort study assessing measures of cardiometabolic status, body composition, IR and GH response to stimulation after therapy in children (age 7-21 years) treated for ALL. Read more about this study
- Who is it for?
- Ages 7 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 7 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Study entry is open to patients regardless of gender or ethnic background. While there will be every effort to seek out and include females and minority patients, the patient population is expected to be no different than the general pediatric oncology population seen at the participating institutions.
Who may be able to join
- Patients
- Age 7 years to less than or equal to 21 years at time of study enrollment.
- Acute lymphoblastic leukemia (ALL) as first cancer diagnosis and in first complete remission. Any subtype is eligible.
- Study enrollment must take place at/after six months of completion of all chemotherapy.
- Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.
- Any prior ALL therapy is allowable.
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- Siblings
- Age 7 years to less than or equal to 21 years at time of study enrollment.
- Sibling of ALL patient.
Who cannot join
- Patients
- Diagnosis of diabetes mellitus prior to ALL diagnosis or at time of study enrollment.
- Current pregnancy
- Prior hematopoietic cell transplant.
- Receiving growth hormone replacement or corticosteroids at the time of enrollment.
- Siblings
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- Previously diagnosed with malignancy.
- Diagnosis of diabetes mellitus.
- Current pregnancy
- Receiving growth hormone replacement or corticosteroids at the time of enrollment.
About this study
Official title: Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia, A Pilot Study
This is a prospective cohort study assessing measures of cardiometabolic status, body composition, IR and GH response to stimulation after therapy in children (age 7-21 years) treated for ALL. Patients and sibling controls will be recruited from the Pediatric Hematology-Oncology Clinic at the University of Minnesota Amplatz Children's Hospital.
Read the detailed description
This is a prospective cohort study with two groups: survivors of acute lymphoblastic leukemia (ALL) who have recently completed therapy (cases) and healthy siblings (controls) frequency matched by age and sex. Subjects in each group will have two visits. For cases, the first visit will be approximately 6 months after completion of treatment for ALL; for their siblings, the first visit occur at approximately the same time. For both cases and controls, the second visit will be 2 to 2.5 years after the first visit.
- Conditions
- Acute Lymphoblastic Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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 |
|---|---|---|
| Sibling Controls | Healthy siblings of acute lymphoblastic leukemia (ALL) subjects frequency matched by age and sex. | |
| Acute Lymphoblastic Leukemia Survivors | Survivors of acute lymphoblastic leukemia (ALL) who recently completed therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiometabolic Profile
To determine the cardiometabolic profile (as measured by a single score based on adiposity, serum lipids, and vascular function) shortly after therapy (6 months after completion of therapy [Visit 1]) and again 2.5-3 yrs after completion of therapy (Visit 2) in 300 ALL patients, and compare with 200 sibling controls.
Measured: up to 2.5-3 Years
Secondary outcomes (1)
Prevalence of Blunted Stimulated Growth Hormone Response
To determine the prevalence of blunted stimulated GH response suggesting GH deficiency (peak GH <7mcg/L) in ALL survivors and controls: GH level will be obtained at baseline, then +30, +60, +90 and +120 minutes after clonidine (5 mcg/kg up to 200 mcg by mouth), followed by infusion of arginine (0.5 grams/kg up to 30 grams) with a series of GH levels at +140, +160, +180, +210, and +240 minutes. Blunted response to GH stimulation will be defined as peak GH level<7 mcg/L.
Measured: Between 2.5 and 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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
- 0 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
- NCT01688752
- Sponsor's protocol ID
- 2012NTLS086
- Status last verified
- Aug 2014
- First submitted
- 17 Sep 2012
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
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
- Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia, A Pilot Study
- ClinicalTrials.gov ID
- NCT01688752
- Acronym / sponsor ID
- 2012NTLS086
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- First posted
- 20 Sep 2012 (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.
This is a prospective cohort study assessing measures of cardiometabolic status, body composition, IR and GH response to stimulation after therapy in children (age 7-21 years) treated for ALL. Patients and sibling controls will be recruited from the Pediatric Hematology-Oncology Clinic at the University of Minnesota Amplatz Children's Hospital.
Detailed description
This is a prospective cohort study with two groups: survivors of acute lymphoblastic leukemia (ALL) who have recently completed therapy (cases) and healthy siblings (controls) frequency matched by age and sex. Subjects in each group will have two visits. For cases, the first visit will be approximately 6 months after completion of treatment for ALL; for their siblings, the first visit occur at approximately the same time. For both cases and controls, the second visit will be 2 to 2.5 years after the first visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sibling Controls | – | –Healthy siblings of acute lymphoblastic leukemia (ALL) subjects frequency matched by age and sex. |
| Acute Lymphoblastic Leukemia Survivors | – | –Survivors of acute lymphoblastic leukemia (ALL) who recently completed therapy. |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study entry is open to patients regardless of gender or ethnic background. While there will be every effort to seek out and include females and minority patients, the patient population is expected to be no different than the general pediatric oncology population seen at the participating institutions.
Key inclusion criteria (9 listed)
- Patients
- Siblings
Key exclusion criteria (10 listed)
- Patients
- Siblings
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
Cardiometabolic Profile
Time frame: up to 2.5-3 Years
To determine the cardiometabolic profile (as measured by a single score based on adiposity, serum lipids, and vascular function) shortly after therapy (6 months after completion of therapy [Visit 1]) and again 2.5-3 yrs after completion of therapy (Visit 2) in 300 ALL patients, and compare with 200 sibling controls.
1 secondary outcome
Prevalence of Blunted Stimulated Growth Hormone Response
Time frame: Between 2.5 and 3 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by University of Minnesota.
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 9 inclusion and 10 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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Cardiometabolic Profile (time frame: up to 2.5-3 Years). 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.