NCT00949052终止不适用
Radiation Sensitivity, DNA Repair, and Second Cancers.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Genetic susceptibility to the carcinogenic effects of radiotherapy, tobacco, and UV light and risk of second malignant neoplasms (SMN)
研究概览
简要总结
RATIONALE: Identifying genes that increase a person's susceptibility to second cancers may help the study of cancer treatment.
PURPOSE: This study is looking at genetic susceptibility and risk of second cancers in patients who have undergone stem cell transplant for cancer.
详细描述
OBJECTIVES:
Primary
- Determine whether genetic susceptibility (e.g., inherited differences in radiation sensitivity to normal tissue or genes of xenobiotic metabolism, nucleotide provision, or DNA repair) to the carcinogenic effects of radiotherapy, tobacco, and UV light modifies the risk of second malignant neoplasms (SMN) in patients with cancer treated with hematopoietic stem cell transplantation (HSCT).
Secondary
- Measure inherent sensitivity to radiotherapy via G_2 chromosome radiation sensitivity assay using B-cell lymphoblastoid cell lines derived from pre-HSCT cryopreserved peripheral blood mononuclear cells of patients with and without SMN.
- Measure the frequency of allelic variants of genes involved in xenobiotics metabolism, DNA repair, and provision of nucleotide pool and compare the frequencies among patients with and without SMN, determine the transmission of specific alleles of these genes from parents to patients, and correlate allelic variants of DNA repair and nucleotide provision in genes with in vitro radiation sensitivity.
- Evaluate the role of potentially carcinogenic environmental exposures (tobacco and sun light) pre- or post-HSCT in the risk of SMN and examine the association of these exposures with SMN and the interaction of these exposures with allelic variants of genes involved in xenobiotic metabolism, nucleotide provision, and DNA repair.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CASES are those who:
- •Survived at least 100 days post-hematopoietic stem cell transplantation (HSCT).
- •Developed an SMN after that time point.
- •And received TBI as part of the preparative regimen.
- •CONTROLS are randomly selected:
- •In a 4:1 ratio to cases from the same cohort of 100 day + survivors of HSCT who received TBI.
- •Controls will be matched to the cases by race and primary diagnosis.
- •In addition, they must have survived for at least the elapsed time between the case's HSCT and the secondary cancer, without development of an SMN.
- •We are matching on primary diagnosis, as genotype or radiation sensitivity may predispose to specific primary cancers, as well as the SMNs.
- •We are matching on race, as allele frequencies vary widely across ethnic groups.
排除标准
- •Did not survive at least 100 days post-hematopoietic stem cell transplantation (HSCT).
- •Did not develop an SMN after that time point.
- •Did not receive TBI as part of the preparative regimen.
结局指标
主要结局
Genetic susceptibility to the carcinogenic effects of radiotherapy, tobacco, and UV light and risk of second malignant neoplasms (SMN)
时间窗: At study entry
次要结局
- Allelic variants of genes involved in xenobiotics metabolism, DNA repair, and provision of nucleotide pool of patients with SMN compared to their first-degree relatives and patients without SMN(At study entry)
- Role of potentially carcinogenic environmental exposures (tobacco and sun light) pre- and post-HSCT in the risk of SMN(At study entry)
- Radiation sensitivity in B-cell lymphoblastoid cells(At study entry)
研究者
Debra Friedman
Associate Professor of Pediatrics
Vanderbilt University Medical Center
研究点 (1)
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