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Health Effects After Leukemia (HEAL) Research Study


Phase 1
8 Years
21 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

Health Effects After Leukemia (HEAL) Research Study


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.


Inclusion Criteria:



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

- 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

Exclusion Criteria:

- Lack of ability to speak, read, and write English

- Active treatment for graft versus host disease

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers

Outcome Time Frame:

2009-2011

Safety Issue:

No

Principal Investigator

Jill Simmons, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000635797

NCT ID:

NCT00897078

Start Date:

January 2009

Completion Date:

October 2011

Related Keywords:

  • Leukemia
  • cancer survivor
  • healthy, no evidence of disease
  • long-term effects secondary to cancer therapy in children
  • childhood acute lymphoblastic leukemia in remission
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Vanderbilt-Ingram Cancer Center - Cool Springs Nashville, Tennessee  37064