跳至主要内容
临床试验/NCT00339859
NCT00339859已完成不适用

DNA Repair, p53 and Apoptosis Phenotypes in Lung Cancer

National Cancer Institute (NCI)2 个研究点 分布在 1 个国家目标入组 5,625 人开始时间: 1995年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,625
试验地点
2
主要终点
Lung cancer incidence

研究概览

简要总结

The Laboratory of Human Carcinogenesis and the Pharmocogenetics Section of the Genetic Epidemiology Branch will conduct a lung cancer case-control study in Baltimore, Maryland. The primary hypothesis of the study is to determine if mutagen sensitivity, p53 induction and apoptosis in cultured lymphocytes will be predictive of lung cancer risk. While there are some studies that examine mutagen sensitivity, none of these assays has been well-studied in an epidemiological setting. Because of methodological issues described herein, and the proposed development of new assays, this study will be viewed as a pilot and therefore hypotheses generating. The design of this molecular epidemiology study has been specifically developed to test the reliability and validity of the mutagen sensitivity assay, where a case-control study is needed to assess the possibility of case bias (i.e., results vary due to the concurrent presence of lung cancer rather than risk). Importantly, this protocol will establish a resource that will allow for the validation of these assays and also for the study of other biomarkers and gene-environment interactions, especially those related to DNA repair. Th secondary goals of this study are to 1) demonstrate gene-neuro-behavioral interactions for smoking addiction in controls and 2) assess the relationship of sex-steroid metabolism an and estrogen exposure to lung cancer risk. Cases will have histologically confirmed lung cancer and reside in Baltimore an and surrounding areas. They will be identified through six hospitals in Baltimore. Cases will be recently diagnosed and blood will be collected prior to chemotherapy or radiation therapy. Because of this requirement to obtain samples before treatment (or for surgical cases at least two months after surgery), we recognize that case ascertainment will be reduced, but critical data to assess differences between eligible and ineligible subjects will be collected through tumor registries. Two control groups will be used, the first will be hospital-based (frequency matched by age, gender, race, smoking and hospital) and the second will be population-based (frequency matched by age-, gender and race). The first control group will allow us to examine risk factors for lung cancer independent of smoking (odds ration for smoking = 1.0), and the second will allow the results to be extrapolated to the general population and also will be used to validate the phenotyping assays. The strategy for recruitment will allow us to over-sample for women and African Americans, so that after examination of data for the entire study group, we can assess differences by these subgroups. Cases and controls will receive a structured, in person interview assessing prior medical and cancer history, tobacco use, alcohol use, current medications, occupational history, family medical history, menstrual history and estrogen use, recent nutritional supplements and caffeine intake, and socioeconomic status. The questionnaire also will include the Fagerstrom index for nicotine dependence (FTND), Center for Epidemiologic Studies Depression (CES-D) scale, and a modified version of the Horn-Waingrow Reasons for Smoking (RFS) Scale. The phenotypic markers to be studied will assess DNA repair with cellular response by using lymphocyte cultures exposed in vitro to radiation, bleomycin, benzo(a)pyrene-diol-expoxide and N-methyl-nitrosurea and then measuring induction of chromosomal aberrations, p53 induction and apoptosis. DNA from cases and controls also will be used for genetic polymorphism analysis of carcinogen metabolism, and those relating to the dopaminergic system and nicotinic receptors. Tumors from cases will be evaluated for estrogen and progesterone receptors. The target accrual number of total subjects will be 1,200 where there will be 100 cases for each combination of gender and race (Caucasian- and African Americans), matched to 100 each of the hospital-based and population-based controls.

详细描述

Background:

The Laboratory of Human Carcinogenesis is conducting an observational non-small cell lung cancer (NSCLC) case-control study in Baltimore, MD. This molecular epidemiology study was developed to test the reliability and validity of the mutagen sensitivity assay, where a case-control study is needed to assess the possibility of case bias. Importantly, this protocol establishes a resource that allows for the study of additional biomarkers and gene-environment interactions. Upon recruitment, cases and controls receive a structured, in person interview assessing prior medical and cancer history, use of tobacco and electronic cigarettes, alcohol use, current medications, occupational history, family medical history, menstrual history and estrogen use, recent nutritional supplements and caffeine intake, and socioeconomic status. Specimen collection consists of a one-time blood sample and/or mouthwash to collect cheek cells (oral cells) and a one-time urine sample. In addition, cancer and surrounding non-cancer tissue that was surgically removed and not needed for diagnosis may be obtained for cases, as well as current medical information from medical records. Primary cell cultures may be established from available fresh tumor tissue. The phenotypic markers to be studied will assess proficiency of DNA repair in lymphocyte cultures exposed in vitro to radiation, bleomycin, benzo(a)pyrene-diol-epoxide by measuring induction of chromosomal aberrations, p53 and apoptosis. DNA from buffy coats or cheek cells will be used for analysis of germline variation in the form of Single Nucleotide Polymorphisms (SNPs) in genes involved in DNA repair, innate immunity, cell cycle control, angiogenesis, apoptosis, cytokines, nicotine addiction, inflammation, hormone metabolism and microRNA. Additionally, IRB approval was received in 2010 to include this study in a multi-institution genome-wide association study (GWAS) of lung cancer in African Americans. Tumors from cases will be evaluated for estrogen and progesterone receptors, somatic mutations, and gene expression. Urine, plasma, serum and tissue sample metabolomics will be analyzed by untargeted approach.

Objectives:

  1. To determine if mutagen sensitivity, p53 induction, and apoptosis in cultured lymphocytes are predictive of lung cancer risk.
  2. To determine the relationship between sex-steroid metabolism, estrogen exposure, and lung cancer risk.
  3. To investigate and develop phenotypic or predictive markers of lung cancer risk and survival, based on mutagen sensitivity, polymorphic markers, gene expression, and metabolomics.
  4. To investigate racial disparities associated with lung cancer risk and survival.
  5. To examine the relationship between circulating cytokines with risk and survival of lung cancer and to establish the most robust method of cytokine detection.
  6. To generate a more accurate measure of ancestry using ancestry informative marker analysis and to integrate this variable into our studies of health disparities
  7. To conduct studies of metabolomics on serum, plasma and urine for the purposes of discovering novel markers of risk, diagnosis and prognosis. We will use ultraperformance liquid chromatography coupled to mass spectrometry (UPLS-MS) to search for small molecular weight endogenous metabolites that can classify cancer and predict outcome.

This is a novel approach for biomarker discovery that also leverages the non-invasive process of biospecimen collection. Tumor and corresponding non tumor tissues from corresponding patients will also be tested using the same methods to extend the discovery of novel tumor metabolites. Further, metabolites of vitamin D will be examined on serum samples from lung cancer cases and controls to assess the relationship between circulating

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Lung cancer incidence

时间窗: At diagnosis

Pathological diagnosis of lung cancer

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验