Suspended

Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors

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What is being collected

Data Collection

+ other Data
Collected from today forward - Prospective
Other
DNA Samples
Who is being recruted

Childhood Malignant Neoplasm

Until 99 Years

See all eligibility criteria

How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: March 2004

See protocol details

Summary

Principal SponsorChildren's Oncology Group
Last updated: March 7, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: March 25, 2004Actual date on which the first participant was enrolled.

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. 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.

Official TitleKey Adverse Events After Childhood Cancer 
Principal SponsorChildren's Oncology Group
Last updated: March 7, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
3885 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Case-Control
These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

What happens to patients' samples
Samples from participants are kept, and they can be used to extract DNA in the future. These might include things like blood or frozen tissue. This allows researchers to study genetics and how DNA may relate to the disease.

Other Options for Sample Use
Samples Without DNA: Samples are kept but not usable for DNA analysis.
None Retained: No samples are kept after the study.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective: These studies use existing medical records or past data.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Until 99 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Childhood Malignant Neoplasm
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.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.
Study Objectives
Primary Objectives

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.

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.

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.

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
Suspended
Children's Hospital of AlabamaBirmingham, United StatesSee the location
Suspended
University of Alabama at Birmingham Cancer CenterBirmingham, United States
Suspended
Arkansas Children's HospitalLittle Rock, United States
Suspended
University of Arkansas for Medical SciencesLittle Rock, United States
Suspended156 Study Centers