NCT01708421

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

5.8 years

First QC Date

October 15, 2012

Last Update Submit

November 5, 2018

Conditions

Childhood Leukemia

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Arizona

Tucson, Arizona, 85721-0203, United States

Location

Children's Hospitals & Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Baylor College of Medicine/ Texas Children's Cancer Center

Houston, Texas, 77030, United States

Location

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.

Study Officials

  • Marilyn Hockenberyy, PhD

    Duke University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2012

First Posted

October 17, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

November 6, 2018

Record last verified: 2018-11

Locations

US(4)