Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Genetic Predisposition to Disease

Disease Susceptibility

Disease Attributes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Qing Lan, M.D.

Background:

* Women in Xuan Wei County, China, are almost all non-smokers, yet they have the highest lung cancer rate in that country.
* Non-smoking women in Xuan Wei who use smoky coal for cooking and heating homes can inhale 10 times higher levels of polycyclic aromatic hydrocarbons (PAH, compounds formed in many burning organic substances, including smoky coal) than someone who smokes 20 cigarettes a day.

Objectives:

* Determine the health effects of smoky coal in Xuan Wei and Fu Yuan counties in China's Yun Nan Province
* Determine how different levels of exposure to smoky coal and other types of fuel affect the amount of smoky coal emissions that are absorbed into the body
* Determine genetic risk factors for lung cancer in the study population and determine how they interact with smoky coal and PAH exposure.

Eligibility:

* Women from Xuan Wei and Fu Yuan counties between 18 and 79 years of age who have lung cancer and do or do not use smoky coal
* Women from Xuan Wei and Fu Yuan counties between 18 and 79 years of age who do not have lung cancer and do or do not use smoky coal

Design:

-Exposure assessment study for users of smoky coal - 150 households

Use of air badges, monitors, and dermal badges to determine subjects' exposure to smoky coal

Collection of blood, urine, cheek cell and sputum samples to measure the amount of smoky coal emissions absorbed into the body and evaluate the types of biologic changes they cause

Interview subjects about their health and family history, occupational exposures, lifestyle factors (e.g., tobacco smoking and diet), and inherited differences in genes

-Case-control study - 1,000 women

Collection of blood, urine, cheek cell and sputum samples to measure how amount of smoky coal emissions absorbed into the body and evaluate types of biologic changes they cause

Interview subjects about their health and family history, occupational exposures, lifestyle factors (e.g., tobacco smoking and diet), and inherited differences in genes

Gene analysis to determine if a genetic variation is associated with an increased or decreased risk of health effects from smoky coal exposure

Females in Xuan Wei County are almost all non-smokers, yet they have the highest lung cancer rate in China. Non-smoking women in Xuan Wei who use smoky coal in their home can inhale ten times higher levels of PAHs than a 20 cigarette per day active smoker, and air concentrations approach levels experienced by workers on the top-side of coke ovens. Several lines of research have provided strong support that the excess lung cancer in this region is caused primarily by PAHs derived from smoky coal exposure. As such, this region of China provides one of the best opportunities in the world to carry out a model study of gene-environment interactions in lung cancer. We have designed a hospital-based case-control study of 500 lung cancer cases and 500 controls among non-smoking women, with controls to be selected through a randomized recruitment design to achieve balance for the main effects of smoky coal exposure and ultimately greater power to detect interactions. The study will be carried out over a three-year period in Xuan Wei and Fu Yuan Counties in Yun Nan Province, China. In addition, we will be carrying out an exposure assessment study (n=150 households) to evaluate air and dermal exposure to PAHs from smoky coal use in order to model PAH exposure experienced by subjects in the case-control study. We will collect buccal cell, sputum, blood, and urine samples from all subjects. The primary goal of the study is to characterize genetic risk factors at the DNA level for lung cancer in this population and determine how they interact with smoky coal and PAH exposure. In addition, the hospital-based design will enable us to collect venous blood samples and cryopreserve lymphocytes, which will allow us to carry out state-of-the-art functional susceptibility assays such as testing ability to repair PAH-damaged DNA and apoptotic capacity, and to measure integrative markers of genomic stability such as telomere length and oxidative damage in mitochondrial DNA. These types of assays have never been conducted in this population and hold great promise to provide insights into cancer risk that will compliment those obtained by genotyping. This study will provide an important complement to and contrast with both DCEG and extramural studies of tobacco smoking and lung cancer, where unraveling the genetic component is challenging in part because hundreds of tobacco carcinogens in various combinations likely contribute.

Smoky Coal Exposure, Genetic Susceptibility, and Lung Cancer in Non-Smoking Women in China

A Hospital-Based Case-Control Study of Non-Smoking Women in Xuan Wei and Fu Yua, China: PAH Exposure, Genetic Susceptibility, and Lung Cancer

Outcome from this study will include the observation of response-gradient for PAHs exposure due to indoor burning biomass and risk of lung cancer.

Outcome will involve discovering genes related to lung cancer risks among non-smoking Asian women.

Outcome will also involve the GXE analysis to explore the interaction between genetic factors and environmental exposure.

National Cancer Institute (NCI)

All Drugs and Chemicals

Anti-Infective Agents

Tin Fluorides

Antitubercular Agents

Bilirubin

Age 50 to 80 years who have at least a 20-pack-year smoking history with successful smoking cessation history (stopping smoking for more than 6 months), but less than 15 years

First-degree relatives of lung cancer patients

1. aged more than 50 years
2. age less than 50 years old, but older than the age at diagnosis of the youngest lung cancer proband in the family

Age 50 to 80 years, meet one or more of the following criteria.

1. air-pollution exposed occupations (such as traffic policeman, street cleaners....) for at least 10 years
2. cooking index ≥ 110, defined as 2/7 \* days cooking by pan frying, stir frying, or deep frying in one week \* years cooking.
3. cooking without using ventilation for more than 20 years
4. history of pulmonary tuberculosis and complete anti-tuberculosis treatment with interval more than 5 years before this study

1. Participants belonging to modified Lung RADS category 1 and 2 at baseline screening will undergo the LDCT next year after the discussion with the physicians in charge.
2. Participants with nodules belonging to modified Lung RADS category 3 and 4, growing nodules, or new nodules found on follow-up LDCT scans will undergo repeat CT every 3 to 6 months or be referred for diagnostic workup depending on the size and characteristics of the nodules as the regular clinical practice.
3. Volume doubling time (VDT) will be performed in the special groups with Lung RADS category 3 or 4, but the nodules with solid components ≧ 6mm and \< 9mm. A repeat LDCT scan will be performed around 3 months after the baseline screening.
4. Check total bilirubin, urinary heavy metals, serum tumor marker, including CEA, alpha-fetal protein, etc.
5. Check pulmonary function test.

Low dose computed tomography

GeeChen Chang, MD. PhD

Chong-Jen Yu, MD PhD

Chung-Ping Hsu, MD PhD

Yu-Feng Wei, MD PhD

Inn-Wen Chong, MD PhD

Po-Hao Feng, MD PhD

GEECHEN CHANG, MD, PhD

Chao-Chi Ho, MD PhD

Lung cancer is the leading cause of mortality in the world, and also in Taiwan.Despite the researches and availability in new therapies, it causes the highest mortality and is one of the most preventable cancers as well. Smoking is the most common cause of lung cancer worldwide. Compared to lung cancer in smokers, lung cancer in never-smokers is associated with East Asian ethnicity, female sex, and adenocarcinoma histology. This unique risk group is likely to have distinct molecular drivers, especially EGFR, ALK, and ROS1 mutations.In National Taiwan Cancer Registry data, more than half (53%) of all newly diagnosed lung cancer patients and 93% of female patients are lifelong never-smokers. This scenario is common in East Asia. It is essential to develop a different strategy for screening lung cancer patients with other high-risk profiles. Several risk factors have been identified in never-smoking lung cancer and one of the most important factor is a lung cancer family history (LCFH) in a first-degree relative. Other high-risk occupational or environmental factors include air-pollution exposed occupations (such as traffic policeman and street cleaners) for at least 10 years, cooking index ≥ 110, defined as 2/7 \* days cooking by pan frying, stir frying, or deep frying in one week \* years cooking, cooking without using ventilation, passive smoke exposure, and history of pulmonary tuberculosis or chronic obstructive pulmonary disorders.

As described above, three high risk groups are interested in this study, the previous heavy smokers (group 1); those who has family history (group 2) and those who have high risk occupation or environment factors (group 3). From the published researches, we assume the detection rate to be 1.1% for group 1 based on NLST results16, 2.6% for group 2 (395 out of 12,011 subjects in TALENT), and we assume the detection Group 3 to be 1% after consulting board-certified senior specialists in this field.

This is a prospective, multi-center, single arm study in Taiwan of subjects who are eligible to receive LDCT screening based on recommendation of Health Promotion Administration of Taiwan.

The primary objective of TRIO part A is the LDCT screening acceptance rate of high lung cancer risk subjects.

The primary objective of TRIO part B is the exact lung cancer detection rates in these three groups.

Other secondary objectives are also included.

blood samples, urine samples, lung tissue samples.

Taiwan Real-world LDCT Screening Behavior and Outcome Research for High Risk Subjects Based on Health Promotion Administration

Taiwan Real-world Low-dose Computed Tomography Screening behavIor and Outcome Research for High Risk Subjects Based on Health Promotion Administration-part A: Questionnaire Survey -Part B: LDCT Screening Outcome and Management

1. Eligible participants must meet the inclusion and exclusion criteria of this study
2. Only the one who completes the detailed questionnaire survey is counted.

Cytological or Pathological proof of lung cancer to investigate the overall lung cancer detection rate

AstraZeneca

Gee-Chen Chang

Chung Shan Medical University

Controlled Exposure to Environmental Contaminant

The research is to evaluate benzene metabolism after exposure at levels that can be found in the environment, such as the higher end concentrations in the air inside cars and buses while being driven in heavy traffic and inside private and public parking garages. To do so breath, urine, and blood samples prior to, during and after being exposed to benzene as well as benzene levels and benzene metabolites present are measured.

The research is to evaluate benzene metabolism after exposure at levels that can be found in the environment, such as the higher end concentrations in the air inside cars and buses while being driven in heavy traffic and inside private and public parking garages. To do so breath, urine, and blood samples prior to, during and after being exposed to benzene as well as benzene levels and benzene metabolites present are measured. The exposures take place in the Controlled Environmental Facility operated by the Environmental and Occupational Health Sciences Institute (EOHSI). This allows us to control the exact benzene air level and to use benzene containing 13C, a stable (non-radioactive) form of carbon, one of the atoms that make up benzene. Isotopes are different forms of the same atom. Using 13C will allow us to tell the difference between the benzene and the compounds it changes to in the body that come from our experiment compared to what is present in your body from other sources. In addition to just benzene exposure on some days the subject is also be exposed to methyl tertiary butyl ether (MTBE), another component of gasoline, to take an iron supplement pill and/or to take vitamins C and E pills. How benzene is metabolized or changed in the body will be compared for these differences to better understand how the body deals with benzene.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Smoky Coal Exposure, Genetic Susceptibility, and Lung Cancer in Non-Smoking Women in China	NCT00482118	Lung Neoplasms		18 Years - 79 Years	National Institutes of Health Clinical Center (CC)
Taiwan Real-world LDCT Screening Behavior and Outcome Research for High Risk Subjects Based on Health Promotion Administration	NCT05557487	Lung Cancer High-Risk Cance... Smoking Pollution; Expo... Family Relation...	Low dose comput...	20 Years - 80 Years	Chung Shan Medical University
Modulation of Benzene Metabolism by Exposure to Environment	NCT00041860	Lung Diseases Cancer	Controlled Expo...	-	National Institute of Environmental Health Sciences (NIEHS)

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