Childhood LeukemiaNCT01708421
Symptom Clusters in Children With Leukemia
An observational study of Childhood Leukemia, run by Duke University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Childhood Leukemia
- How many people
- 338 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2012to 1 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children between 3-18 years of age undergoing treatment for leukemia.
Who may be able to join
- Phenotypic and genotypic treatment-related symptom associations will be evaluated in children and adolescents 3-18 years of age with a diagnosis of leukemia.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine/ Texas Children's Cancer Center
Houston, Texas, 77030
Children's Hospitals & Clinics of Minnesota
Minneapolis, Minnesota, 55404
University of Arizona
Tucson, Arizona, 85721-0203
About this study
Official title: Phenotypic and Genotypic Associations With Symptom Clusters During Childhood Leukemia Treatment
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.
Read the 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.
- Conditions
- Childhood Leukemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startNov 2012
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood LeukemiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marilyn Hockenberyy, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708421
- Sponsor's protocol ID
- Pro00037891
- Status last verified
- Nov 2018
- First submitted
- 15 Oct 2012
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Genotypic Associations With Symptom Clusters During Childhood Leukemia Treatment
- ClinicalTrials.gov ID
- NCT01708421
- Acronym / sponsor ID
- Pro00037891
- Conditions
- Childhood Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 17 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children between 3-18 years of age undergoing treatment for leukemia.
Key inclusion criteria (1 listed)
- Phenotypic and genotypic treatment-related symptom associations will be evaluated in children and adolescents 3-18 years of age with a diagnosis of leukemia.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn Hockenberyy, PhD principal investigator
Duke University School of Nursing
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Leukemia, run by Duke University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.