Study of Metabolic Syndrome in Young Patients Who Are Acute Lymphoblastic Leukemia Survivors and Their Healthy Siblings

NCT00897078 | Completed DMC

• 3 other identifiers: CDR0000635797VU-VICC-PED-0888081208
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 2

Brief 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 healthy sibling volunteers.

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

Outcome Measures

Primary Outcomes (2)

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

  2009-2011

• Host- and treatment-related risk factors for MS

  2009-2011

Interventions

laboratory biomarker analysis OTHER

Also known as: none noted

medical chart review OTHER

Also known as: none noted

metabolic assessment OTHER

Also known as: none noted

questionnaire administration OTHER

will be obtained at a single clinic visit

Also known as: none noted

assessment of therapy complications PROCEDURE

Also known as: none noted

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Lack of ability to speak, read, and write English
• Active treatment for graft versus host disease

Sponsors & Collaborators

• Vanderbilt University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Banked DNA

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jill Simmons, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: January 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 13, 2013

Record last verified: 2013-06

Locations

US (2)