Status:
ACTIVE_NOT_RECRUITING
Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Childhood Malignant Neoplasm
Eligibility:
All Genders
Up to 99 years
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 m...
Detailed Description
PRIMARY OBJECTIVES: I. To identify key adverse events developing in patients (cases) with a primary cancer diagnosed at age 21 or younger. II. To characterize the key adverse events with respect to ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 25 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
3885 Patients enrolled
Trial Details
Trial ID
NCT00082745
Start Date
March 25 2004
Last Update
March 7 2025
Active Locations (156)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
3
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
4
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205