Clinical trial · Observational
Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors
Key Adverse Events After Childhood Cancer
NCT00082745CI-TRIAL-00111841completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Malignant Neoplasm | Childhood Malignant Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (genetic analysis)
- description
- 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.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Questionnaire Administration
Primary outcomes (3)
- measure
- Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control)
- timeFrame
- Up to 1 year
- description
- 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.
- measure
- Frequency of mutations or polymorphisms in specific candidate genes in cases and controls
- timeFrame
- Up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDSingh P, Zhou L, Shah DA, Cejas RB, Crossman DK, Jouni M, Magdy T, Wang X, Sharafeldin N, Hageman L, McKenna DE, Horvath S, Armenian SH, Balis FM, Hawkins DS, Keller FG, Hudson MM, Neglia JP, Ritchey AK, Ginsberg JP, Landier W, Burridge PW, Bhatia S. Identification of novel hypermethylated or hypomethylated CpG sites and genes associated with anthracycline-induced cardiomyopathy. Sci Rep. 2023 Aug 4;13(1):12683. doi: 10.1038/s41598-023-39357-2. PMID 37542143
- DERIVEDWang X, Sun CL, Quinones-Lombrana A, Singh P, Landier W, Hageman L, Mather M, Rotter JI, Taylor KD, Chen YD, Armenian SH, Winick N, Ginsberg JP, Neglia JP, Oeffinger KC, Castellino SM, Dreyer ZE, Hudson MM, Robison LL, Blanco JG, Bhatia S. CELF4 Variant and Anthracycline-Related Cardiomyopathy: A Children's Oncology Group Genome-Wide Association Study. J Clin Oncol. 2016 Mar 10;34(8):863-70. doi: 10.1200/JCO.2015.63.4550. Epub 2016 Jan 25. PMID 26811534