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Symptom Clusters in Children With Leukemia

This study is currently recruiting participants.
Verified April 2013 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01708421
First received: October 15, 2012
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to examine the phenotypic and genotypic characteristics and their associations with symptom clusters experienced during treatment for childhood leukemia.


Condition
Childhood Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phenotypic and Genotypic Associations With Symptom Clusters During Childhood Leukemia Treatment

Resource links provided by NLM:

MedlinePlus related topics: Leukemia
U.S. FDA Resources

Further study details as provided by Duke University:

Biospecimen Retention:   Samples With DNA

A baseline CSF sample will be obtained prior to intrathecal chemotherapy. CSF biomarkers will be obtained at the initiation of post-induction, 4 and 6 months into post-induction therapy, and at the start of maintenance therapy.A saliva sample will be obtained for genotypic analysis at one of the four data collection times.


Estimated Enrollment: 400
Study Start Date: November 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Detailed Description:

A repeated measures research design will evaluate phenotypic and genotypic treatment-related symptom associations experienced by children and adolescents 3-17 years of age with a diagnosis of leukemia.

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children between 3-18 years of age undergoing treatment for leukemia.

Criteria

Inclusion Criteria:

  • Phenotypic and genotypic treatment-related symptom associations will be evaluated in children and adolescents 3-18 years of age with a diagnosis of leukemia.

Exclusion Criteria:

  • Children without a definite diagnosis of leukemia will be excluded.
  • Children must be able to understand and answer the questions on the questionnaires.
  • Children with have a cognitive impairment (e.g. Down syndrome) will not be able to complete the questionnaires and will not be eligible for the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708421

Contacts
Contact: Marilyn Hockenberry, PhD 919-684-9330 marilyn.hockenberry@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Marilyn Hockenberry, PhD     919-684-9330        
Principal Investigator: Sharron Docherty, PhD,CPNP            
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Marilyn Hockenberyy, PhD Duke University School of Nursing
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01708421     History of Changes
Other Study ID Numbers: Pro00037891
Study First Received: October 15, 2012
Last Updated: April 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Syndrome
Neoplasms by Histologic Type
 Neoplasms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013