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Interindividual Genetic Variability as a Determinant of Chemotherapy Toxicity and Response in Pediatric Bone Marrow Transplantation Patients

Interindividual Genetic Variability as a Determinant of Chemotherapy Toxicity and Response in Pediatric Oncology/Bone Marrow Transplantation Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00578630
Enrollment
128
Registered
2007-12-21
Start date
2003-10-14
Completion date
2018-11-30
Last updated
2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

pediatric tumors, genetic test development, All Pediatric patients with a histologically proven tumor.

Brief summary

The purpose of this study is to develop tests that will allow us to determine who will react differently to the drugs used to treat cancer. We also want to see who will react differently with preparing for a bone marrow transplant.

Detailed description

The title of this study is interindividual genetic variability as a determinant of chemotherapy toxicity and response in pediatric oncology/bone marrow transplantation patients. We will collect blood from pediatric oncology/bone marrow transplantation patients who are going to receive chemotherapy in order to assess several defined genetic polymorphisms that may be involved in chemotherapy toxicity and response. The polymorphisms will be assessed on normal mononuclear cells by a combination of techniques. We will determine whether these polymorphisms occur in pediatric oncology/bone marrow transplantation patients and their correlation with different clinical features during and following therapy including toxicity and response. The presence or absence of polymorphisms will be correlated with patient outcome and tumor recurrence.

Interventions

OTHERbuccal swabs and obtaining peripheral blood

will be the collection of normal cells and assessments of toxicity following chemotherapy at routine clinic visits.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
American Cancer Society, Inc.
CollaboratorOTHER
Montefiore Medical Center
CollaboratorOTHER
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All Pediatric Oncology and Bone Marrow Transplantation Service patients with a histologically proven tumor for whom there is an intent to treat with chemotherapy are eligible for participation in this study. The patient does not need to be newly diagnosed for enrollment on this protocol. * All patients or their guardians must provide written informed consent. Minors will be required to provide assent.

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
To determine if genetic polymorphisms are associated with the presence and extent of chemotherapy related toxicity in pediatric bone marrow transplantation patients and the response and outcome of these patients.12 months

Secondary

MeasureTime frame
To determine if the presence of genetic polymorphisms are associated with the response and outcome of pediatric oncology/bone marrow transplantation patients.12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026