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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00082745




Registration number
NCT00082745
Ethics application status
Date submitted
14/05/2004
Date registered
19/05/2004
Date last updated
18/07/2019

Titles & IDs
Public title
Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors
Scientific title
Key Adverse Events After Childhood Cancer
Secondary ID [1] 0 0
NCI-2011-03822
Secondary ID [2] 0 0
ALTE03N1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer Survivor 0 0
Cardiovascular Complication 0 0
Childhood Malignant Neoplasm 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Laboratory Biomarker Analysis
Other interventions - Questionnaire Administration

Ancillary-Correlative (genetic analysis) - DNA from peripheral blood or buccal sample of patients is analyzed for the presence of polymorphisms in candidate genes associated with an increased risk of late-occurring complications.


Other interventions: Laboratory Biomarker Analysis
Correlative studies

Other interventions: Questionnaire Administration
Ancillary studies

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control) - Epidemiological, clinical and laboratory variables will be tested for their association with key adverse events. McNemar?s test for paired data will be used to compare the unmatched general characteristics of cases and controls.
Timepoint [1] 0 0
Up to 1 year
Primary outcome [2] 0 0
Frequency of mutations or polymorphisms in specific candidate genes in cases and controls - Allele frequencies will be estimated by the gene counting method, and the chi-square test will be used to check for departures from Hardy-Weinberg equilibrium.
Timepoint [2] 0 0
Up to 1 year
Primary outcome [3] 0 0
Crude disease-exposure - The crude disease-exposure association will be determined by estimating the OR and its 95% confidence interval (CI). This will be done by univariate conditional logistic regression, to account for the matched design. The significance of the OR will be assessed by the Wald test. Backward stepwise regression procedures will be used to develop the final multivariate model and possible interactions will be examined. The fit of the model will be assessed by the logistic regression diagnostics procedure.
Timepoint [3] 0 0
Up to 1 year

Eligibility
Key inclusion criteria
- ELIGIBILITY CRITERIA - CASES

- Diagnosis of primary cancer at age 21 or younger, irrespective of current age

- No prior history of allogeneic (non-autologous) hematopoietic cell transplant

- Development of one of the following key adverse events at any time following
initiation of cancer therapy:

- Cardiac dysfunction; please note: case enrollment has been closed due to
achievement of target accrual

- Ischemic stroke (IS)

- Subsequent malignant neoplasm (SMN)

- Avascular necrosis (AVN); please note: case enrollment has been closed due to
achievement of target accrual

- Submission of a blood specimen (or in certain cases a buccal cell specimen) to the
Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital as per
the requirements; please note: if a patient is currently receiving active cancer
treatment, it is preferable to obtain the blood sample at a time when the patient's
white blood cell (WBC) is > 2,000

- Written informed consent from the patient and/or the patient?s legally authorized
guardian

- In active follow up by a COG institution; active follow up will be defined as date of
last visit or contact by a COG institution within the past 24 months; any type of
contact, including contact specifically for participation in ALTE03N1, qualifies as
active follow-up; please note: treatment on a COG (or legacy group) therapeutic
protocol for the primary cancer is NOT required

- ELIGIBILITY CRITERIA - CONTROLS

- CONTROL: Diagnosis of primary cancer at age 21 or younger, irrespective of current age

- CONTROLS: No prior history of allogeneic (non-autologous) hematopoietic cell
transplant

- CONTROLS: No clinical evidence of any of the following key adverse events:

- Cardiac dysfunction (CD); please note: if a patient is currently receiving active
cancer treatment, it is preferable to obtain the blood sample at a time when the
patient's WBC is > 2,000

- Myocardial infarction (MI)

- Ischemic stroke (IS)

- Avascular necrosis (AVN)

- Subsequent malignant neoplasm (SMN)

- CONTROLS: Submission of a blood specimen (or in certain cases a buccal cell specimen)
to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital
as per the requirements

- CONTROLS: Written informed consent from the patient and/or the patient?s legally
authorized guardian

- CONTROLS: In active follow up by a COG institution; active follow up will be defined
as date of last visit or contact by a COG institution within the past 24 months; any
type of contact, including contact specifically for participation in ALTE03N1,
qualifies as active follow-up; please note: treatment on a COG (or legacy group)
therapeutic protocol for the primary cancer is NOT required
Minimum age
No limit
Maximum age
21 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
Royal Children's Hospital-Brisbane - Herston
Recruitment hospital [3] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [5] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment hospital [7] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 0 0
6008 - Perth
Recruitment postcode(s) [6] 0 0
6009 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maine
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Utah
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Vermont
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Nova Scotia
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Ontario
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Quebec
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Saskatchewan
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Puerto Rico
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San Juan
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Switzerland
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Geneva

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This clinical trial studies cancer survivors to identify those who are at increased risk of
developing late-occurring complications after undergoing treatment for childhood cancer. A
patient's genes may affect the risk of developing complications, such as congestive heart
failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment.
Genetic studies may help doctors identify survivors of childhood cancer who are more likely
to develop late complications.
Trial website
https://clinicaltrials.gov/show/NCT00082745
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Smita Bhatia
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00082745