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Symptom Clusters in Children With Leukemia

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01708421
First Posted: October 17, 2012
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
  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:


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: August 2020
Estimated Primary Completion Date: August 2020 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708421


Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85721-0203
United States, Minnesota
Children's Hospitals & Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
Baylor College of Medicine/ Texas Children's Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Marilyn Hockenberyy, PhD Duke University School of Nursing
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01708421     History of Changes
Other Study ID Numbers: Pro00037891
First Submitted: October 15, 2012
First Posted: October 17, 2012
Last Update Posted: October 3, 2017
Last Verified: September 2017

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