Endothelial Function, Arterial Stiffness and Components

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01439217
First received: September 21, 2011
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

Specific Aim: Compare the endothelial function, arterial stiffness and components of metabolic syndrome of childhood Acute Lymphoblastic Leukemia (ALL) survivors to healthy sibling controls. Plan: A cross sectional study comparing ALL survivors to sibling controls including measures of endothelial function and arterial stiffness obtained form a peripheral artery tonometry device, height, weight, waist circumference, fasting lipid, glucose and insulin.


Condition
Acute Lymphoblastic Leukemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Endothelial Function, Arterial Stiffness and Components of Metabolic Syndrome in Acute Lymphoblastic Leukemia (ALL) Survivors

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • measure of endothelial [ Time Frame: at enrollment ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: June 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   8 Years to 28 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

This descriptive, healthy sibling control study will utilize a convenience sample of 20 childhood ALL survivors, recruited from the Survivorship Program at Johns Hopkins (SPJH). The study will be introduced to survivors/parent/guardians during routine clinic visits. If they are interested in participation the consent form for both the survivor and sibling will be reviewed and taken home to discuss with the sibling and other family members. Follow-up phone call and questions will be encouraged. If all parties agree to participate an appointment will be set up to enroll the survivor/sibling and face to face informed consent will be obtained.

A second method for recruitment will include mailings (see attached) to ALL survivors seen/treated at Johns Hopkins. Letters will include phone and email contacts to acquire further information and a post card to decline further contact.

Criteria

Inclusion Criteria:

Survivor:

Inclusion

  1. Ages 8-28 (8 is chosen as lower age limit because developmental understanding will allow survivor to follow instructions for procedures, 28 is chosen as upper limit to include age ranges seen for treatment in the pediatric program)
  2. Off therapy for at least 6 months and not more than 10 years (6 months

Inclusion

  1. Biological sibling
  2. Ages 8-28 (when more than one sibling is available the one closest in age will be chosen.))

Exclusion Criteria:

  1. Uncontrolled medical conditions that could interfere with participation or interpretation of results
  2. History of relapsed ALL or history of bone marrow transplantation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439217

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01439217     History of Changes
Other Study ID Numbers: J1064, NA_00040838
Study First Received: September 21, 2011
Last Updated: April 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Acute lymphoblastic leukemia
Survivor
Sibling control

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014