Key Adverse Events After Childhood Cancer
Data Collection
Collected from today forward - ProspectiveNeoplasms
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: March 25, 2004
Actual date on which the first participant was enrolled.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 the nature of the primary malignancy (pathology, stage) and coded details of the therapeutic protocol. III. To identify treatment-related and demographic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis. IV. To compare the frequency of mutations or polymorphisms in specific candidate genes in cases and controls, using constitutional deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) from the cases and controls. V. To explore the role and nature of gene-environment interaction in the development of key adverse events. OUTLINE: DNA and RNA 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.3885 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 99 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 156 locations
University of Alabama at Birmingham Cancer Center
Birmingham, United StatesArkansas Children's Hospital
Little Rock, United StatesUniversity of Arkansas for Medical Sciences
Little Rock, United States