NCT00949052

Genetic Susceptibility and Risk of Second Cancers in Patients Who Have Undergone Stem Cell Transplant for Cancer

Radiation Sensitivity, DNA Repair, and Second Cancers.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. OUTLINE: Patients complete self-reported questionnaires and medical records are reviewed to collect information on UV light and tobacco exposure pre- and post-transplantation. Information is analyzed for association with second malignancy neoplasms. Blood samples are collected from patients pre-hematopoietic stem cell transplantation and from their parents (when available) or other first-degree relatives for genetic biomarkers of susceptibility to second malignancies, DNA repair and provision nucleotide, genetic susceptibility to toxicity from combined cancer therapies, and environmental carcinogens. PROJECTED ACCRUAL: A total of 1,000 patients (800 patients without second malignant neoplasms \[SMN\] and 200 patients with SMN) will be accrued for this study.

Conditions

• Cancer

Interventions

Type	Name	Description
GENETIC	DNA analysis
GENETIC	polymorphism analysis
OTHER	laboratory biomarker analysis
OTHER	medical chart review
OTHER	questionnaire administration
PROCEDURE	assessment of therapy complications
PROCEDURE	evaluation of cancer risk factors

Timeline

• Start date: 2009-01-01
• Primary completion: 2014-12-01
• Completion: 2018-02-01
• First posted: 2009-07-30
• Last updated: 2018-08-16

Locations

1 site across 1 country: United States