Symptom Clusters in Children With Leukemia
This study is currently recruiting participants.
Verified October 2013 by Duke University
Information provided by (Responsible Party):
First received: October 15, 2012
Last updated: October 15, 2013
Last verified: October 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Phenotypic and Genotypic Associations With Symptom Clusters During Childhood Leukemia Treatment
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2017 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||3 Years to 18 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Children between 3-18 years of age undergoing treatment for leukemia.
- Phenotypic and genotypic treatment-related symptom associations will be evaluated in children and adolescents 3-18 years of age with a diagnosis of leukemia.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708421
|Duke University Medical Center
|Durham, North Carolina, United States, 27710 |
|Contact: Marilyn Hockenberry, PhD 919-684-9330 |
|Principal Investigator: Sharron Docherty, PhD,CPNP |
||Marilyn Hockenberyy, PhD
||Duke University School of Nursing
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 15, 2012
||October 15, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 08, 2013
Neoplasms by Histologic Type