Study of Late-Occurring Complications in Childhood Cancer Survivors
Recruitment status was Recruiting
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Purpose
RATIONALE: A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, 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.
PURPOSE: This clinical trial is studying cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer.
| Condition | Intervention |
|---|---|
|
Cancer |
Genetic: cytogenetic analysis Genetic: mutation analysis Genetic: polymorphism analysis Other: questionnaire administration |
| Study Type: | Observational |
| Official Title: | Key Adverse Events After Childhood Cancer |
| Estimated Enrollment: | 6900 |
| Study Start Date: | March 2004 |
| Estimated Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Identify key late-occurring complications, specifically, cardiac dysfunction (closed to accrual as of 4/17/09), myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis (closed to accrual as of 11/26/08), and subsequent malignant neoplasm, in childhood cancer survivors.
- Correlate key late-occurring complications with pathology and staging of the primary malignancy and therapeutic treatment protocol details in these patients.
- Identify treatment-related and demographic risk factors by comparing patients who develop late-occurring complications (case group) vs those with the same primary malignancy who do not develop late-occurring complications (control group).
- Compare the frequency of mutations or polymorphisms in specific candidate genes in both the case and control groups using constitutional DNA and RNA from both groups.
- Explore the role and nature of gene-environment interaction in the development of late-occurring complications in these patients.
OUTLINE: This is a multicenter study.
DNA from peripheral blood or buccal sample of patients is analyzed for the presence of polymorphisms in candidate genes associated with an increased risk of late-occurring complications, such as cardiac dysfunction (closed to accrual as of 4/17/09), myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis (closed to accrual as of 11/26/08), and subsequent malignant neoplasms.
Patients also complete a questionnaire detailing family history and health history.
PROJECTED ACCRUAL: A total of 6,900 patients (1,725 with late-occurring complications [case group] and 5,175 without late-occurring complications [control group] [myocardial infarction patients closed to accrual as of 6/5/06, avascular necrosis patients closed to accrual as of 11/26/08, cardiac dysfunction patients closed to accrual as of 4/17/09]) will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Diagnosis of primary cancer at age 21 or younger
In active follow-up by a Children's Oncology Group (COG) institution
- Date of last visit or contact by a COG institution within the past 24 months
Case group
Development of one of the following key adverse events after initiation of prior cancer therapy:
Cardiac dysfunction, meeting 1 of the following criteria (closed to accrual as of 4/17/09):
Symptomatic cardiac dysfunction, including current or previous diagnosis of congestive heart failure based on any of the following clinical criteria:
- Pulmonary and/or peripheral edema
- Dyspnea
- Orthopnea
- Fatigue
- Hepatomegaly
Asymptomatic cardiac dysfunction
- Ejection fraction < 40% on echocardiogram OR MUGA and/or fractional shortening < 28% on echocardiogram without clinical symptoms
Myocardial infarction, meeting 1 of the following criteria (closed to accrual as of 6/5/06):
- Definite ECG changes
- Typical, atypical, or inadequately described symptoms AND probable ECG, AND abnormal enzymes, including creatine kinase MB
- Typical symptoms AND abnormal enzymes, including creatine kinase MB, AND ischemic ECG, non-codable ECG, or ECG not available
Ischemic stroke, meeting the following criteria:
- Fixed neurological deficit lasting more than 24 hours
- Confirmed by CT scan or MRI within 7 days of onset of symptoms
- No subarachnoid or intracerebral hemorrhage, transient ischemic attacks, or amaurosis fugax
Avascular necrosis, meeting the following criteria (closed to accrual as of 11/26/08):
- Clinical symptoms of joint pain, joint stiffness, or decreased range of motion
- Confirmed by plain radiographs, CT scan, MRI, or bone scan
Subsequent malignant neoplasm, meeting the following criteria:
- Histologically distinct neoplasm developing in patients treated for a primary cancer
- Confirmed by an institutional pathology report
Control group
No clinical evidence of any of the following:
- Cardiac dysfunction (closed to accrual as of 4/17/09)
- Myocardial infarction (closed to accrual as of 6/5/06)
- Ischemic stroke
- Avascular necrosis (closed to accrual as of 11/26/08)
- Subsequent malignant neoplasm
PATIENT CHARACTERISTICS:
Age
- 21 and under at diagnosis, any age at study entry
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- See Disease Characteristics
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No prior allogeneic (non-autologous) hematopoietic cell transplant
Contacts and Locations
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Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00082745 History of Changes |
| Obsolete Identifiers: | NCT00228787 |
| Other Study ID Numbers: | CDR0000360708, COG-ALTE03N1 |
| Study First Received: | May 14, 2004 |
| Last Updated: | April 5, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
cancer survivor unspecified childhood solid tumor, protocol specific long-term effects secondary to cancer therapy in children recurrent/refractory childhood Hodgkin lymphoma stage I childhood Hodgkin lymphoma stage II childhood Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma childhood acute lymphoblastic leukemia in remission childhood acute lymphoblastic leukemia recurrent childhood acute lymphoblastic leukemia de novo myelodysplastic syndromes previously treated childhood rhabdomyosarcoma previously treated myelodysplastic syndromes secondary myelodysplastic syndromes |
childhood acute myeloid leukemia in remission childhood acute myeloid leukemia/other myeloid malignancies recurrent childhood acute myeloid leukemia childhood grade III lymphomatoid granulomatosis recurrent childhood grade III lymphomatoid granulomatosis recurrent childhood large cell lymphoma stage I childhood large cell lymphoma stage II childhood large cell lymphoma stage III childhood large cell lymphoma stage IV childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma stage I childhood lymphoblastic lymphoma stage II childhood lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma |
Additional relevant MeSH terms:
|
Lymphoma, Non-Hodgkin Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 22, 2013