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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00228787




Registration number
NCT00228787
Ethics application status
Date submitted
14/05/2004
Date registered
19/05/2004
Date last updated
8/04/2024

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
COG-ALTE03N1
Secondary ID [2] 0 0
ALTE03N1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Observational (genetic analysis) - DNA from peripheral blood or saliva sample of patients is analyzed for the presence of polymorphisms in genes associated with an increased risk of late-occurring complications.
Comparator / control treatment
Control group

Outcomes

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 saliva specimen) to the Coordinating Center at the University of Alabama at Birmingham 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
* Ischemic stroke (IS)
* Avascular necrosis (AVN)
* Subsequent malignant neoplasm (SMN)
* CONTROLS: Submission of a blood specimen (or in certain cases a saliva specimen) to the Coordinating Center Laboratory at the University of Alabama at Birmingham 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
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/03/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3885
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country

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, avascular necrosis, 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/study/NCT00228787
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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/study/NCT00228787