Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Adenocarcinoma

Lung Neoplasms

Adenocarcinoma of Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Lung Adenocarcinoma

Chao Hsiung, PhD

Lung adenocarcinoma in Chinese females is hypothesized to be determined by both genetic and environmental factors. In this grant proposal, we propose to map the loci of susceptibility genes of female lung adenocarcinoma based on multiplex families recruited in Taiwan. We focus on a unique pathological type of a unique population in order to reduce heterogeneity of the genetic background. Compared with western women, female Chinese population has a high prevalence of lung adenocarcinoma. Our reasoning is that if we focus on a specific sub-type, which has a familial basis, we will increase the probability of identifying genes associated with female lung adenocarcinoma. The primary goal of this study is to identify the genetic and environmental determinants of female lung adenocarcinoma, and study the relationship between gene polymorphisms and clinical manifestation profiling of lung cancer.

This research proposal intends to integrate epidemiologists, biostatisticians, clinicians, molecular biologists/geneticists to identify susceptible genes for lung cancer, especially for female lung adenocarcinoma, and to study the relationship between gene polymorphisms and clinical outcomes of lung cancer patients. Our objective is to find gene markers for developing useful screening tools for the high risk group in order to prevent or early detect lung cancer, especially female lung adenocarcinoma.

The specific aims of this subproject include:

1. Establish and maintain the research network that will recruit and follow up the subjects and families for the GEFLAC study; keeping control of the progress of the study.
2. Coordinate all the subprojects such as integrating genotyping data with clinical data and environment data.
3. Continue to employ the candidate gene approach to examine the contribution of specific genes to the lung cancer.
4. Generate genotyping data for candidate genes in the exploring stage and prioritize SNPs of candidate genes for large scale studies.
5. Identify susceptible genes/candidate genes to develop multiplex PCR for screening.

Genetic Epidemiological Study of Lung Cancer in Taiwan and Clinical Applications

Genetic Epidemiological Study of Lung Cancer in Taiwan and Clinical Applications-focusing on Female Lung Adenocarcinoma (GEFLAC)

National Taiwan University Hospital

Taipei Veterans General Hospital, Taiwan

Chang Gung Memorial Hospital

Taichung Veterans General Hospital

National Cheng-Kung University Hospital

Kaohsiung Medical University

National Health Research Institutes, Taiwan

Dr. Chao Agnes Hsiung

Diseases and Abnormalities at or Before Birth

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Congenital Abnormalities

Urogenital Abnormalities

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

The rates of renal, breast, uterine, ovarian and vaginal cancers in women who have been diagnosed with a CUA will be studies

Alla Vash-Margita, MD

Miranda Margetts, PhD

Monica G Konstantino, RN

Alla Vash-Margita, MD, FACOG

Emanuele Pelosi, MD

The purpose of this research study is to learn more about the health outcomes associated with congenital uterine anomalies (CUAs), and the possible environmental and genetic causes of the condition. The researchers plan to investigate whether any cancer associations (with breast, renal, ovarian, vaginal and uterine cancers) exist in females with CUAs. The investigator will also investigate any environmental and genetic factors that may be responsible for causing CUAs.

Aim 1: To identify female subjects diagnosed with a Congenital Uterine Anomaly (CUA) receiving care at Yale New Haven Health.

Aim 2: Identify (i) the prevalence of renal, breast, ovarian, uterine and vaginal cancers associated with CUAs, and (ii) the association of environmental factors, via a survey obtained by phone, email or interview.

Aim 3: Conduct genetic evaluation of the index subjects, parents, sister(s) (as feasible), and female offspring to identify potential causes and patterns of inheritance using whole exome sequencing (WES) and microarray.

Following informed consent, blood will be collected for genetic evaluation. DNA will be extracted from EDTA-blood and analyzed using an integrated approach of microarray for copy number variations (CNV), and Whole Exome Sequencing (WES) for Single Nucleotide Variation (SNV).

Undertaking review of the medical records will identify the cohort of patients we wish to survey to then ascertain further information regarding their CUA diagnosis and other related details. The information to be elicited from the survey are outlined in the attached survey questions. Key associations we seek to investigate include (1) the type and prevalence of renal, breast, ovarian, uterine and vaginal cancers among patients with Mullerian Anomaly, and (2) identifying potential in-utero exposure to particular environmental agents in patients with CUAs.

Review of the medical records will enable us to undertake this first key step of establishing a cohort of subjects with MA and an initial data set related to their specific health information. We anticipate further investigations may build upon this initial data set, both with the cohort established, and more broadly with collaborators and additional national and international cohorts of patients with MA.

Following informed consent, blood will be collected for genetic evaluation. DNA will be extracted from EDTA-blood and analyzed using an integrated approach of microarray for copy number variations (CNV), and Whole Exome Sequencing (WES) for Single Nucleotide Variation (SNV).

Congenital Uterine Anomalies: Identifying Cancer Associations and Genetic and Environmental Factors to Improve Clinical Care

Prevalence of breast cancer in women with CUA's compared to women without CUA's will be measured

Prevalence of ovarian cancer in women with CUA's compared to women without CUA's will be measured

Prevalence of uterine cancer in women with CUA's compared to women without CUA's will be measured

Prevalence of cervical cancer in women with CUA's compared to women without CUA's will be measured

Prevalence of vaginal cancer in women with CUA's compared to women without CUA's will be measured

Prevalence of renal cancer in women with CUA's compared to women without CUA's will be measured

WES and microarray will be conducted in subjects with CUAs. The discovery of possible causative genes would be measured using yes/no outcome variable.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Yale University

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Obesity

Newsletters, Physical Activity (PA) Prescription Plan, Pedometer

PA Prescription Plan

Pedometer

4 Newsletters with topics based on PA progression phases of adoption and maintenance.

Newsletters

Lorna H. McNeill, PHD, MPH

The goal of this study is to learn why some black and Latino men and women choose not to exercise very often. Researchers also want to learn more about any social and environmental factors that may affect the way an exercise program is followed.

If you chose to take part in this study, you will receive an exercise program, a pedometer, access to a social networking site, and newsletters to help you start becoming more physically active. A pedometer is a small device worn on the hip that counts the number of steps you have taken each day.

Study Visits:

You will come in for study visits 6 times while you are on study; 1 time at the beginning of the study called "screening", 1 time for an orientation visit 7 days after the screening visit, and for follow-up visits at 8, 26, 39, and 52 weeks after you begin the exercise program.

Baseline Tests:

If you are found to be eligible to take part on this study based on the results of the screening tests, the following tests and procedures will be performed:

* You will be asked to complete a computer-based survey. The questionnaires will ask questions about stress, your motivation for physical activity, any social support you may receive from others, the neighborhood you live in, and other physical activity-related topics. The questionnaires should take about 2 hours total to complete.
* Your blood pressure will be measured.
* Your height, weight, and waistline will be measured. To measure your waistline accurately, you may be asked to lift your shirt to expose your stomach area and to lower your pants to expose your mid-hip area. Waistline measurements will only take about 10 minutes to complete and will be performed in a private area.
* You will complete a fitness test. To complete the fitness test, you will either walk a circular path at the clinic for 6 minutes or complete a step test. The study staff will decide which test you will complete and will discuss the test with you in more detail. A study staff member will monitor you during this test.

Study Devices:

At the baseline visit, you will be given the following study devices:

* You will be given a smartphone to take home with you.
* You will fill out a set of questions on the smartphone each time you exercise. The questions will ask about the kind physical activity you are participating in, the location of where the physical activity is taking place, and the weather conditions outside. These questions will take about 1-2 minutes per day. Also, the smartphone will "beep" at random times (3 times per day) and set times (in the morning and evening) throughout the day to prompt you to answer a set of questions about your thoughts and feelings. The device will also automatically record your location using a Global Positioning System (GPS) during the time you are carrying the phone. This will take about 7-8 minutes per day. The research staff will call you 1 time each week to remind you to use the smartphone and will help with any smartphone problems that may occur. Each reminder phone call should last about 3 minutes. You will return the smartphone with you at the orientation visit for the study staff to download your answers.
* You will be given an accelerometer. You will wear the accelerometer for 7 days and then return it at the orientation study visit. An accelerometer is a small device that is worn on your hip that measures the amount of physical activity you do.

Orientation Study Visit:

At the orientation study visit, the following tests and procedures will be performed:

* You will be given a newsletter that contains information and strategies to help you start your exercise program.
* You will be given a smartphone again to take home.
* You will be given a physical activity (PA) prescription. The PA prescription outlines your exercise program and has instructions on the proper way to walk to decrease the chance of getting an injury. You will be instructed to start your PA prescription and carry the smartphone with you for 2 weeks. After 2weeks, you will return the smartphone by mail in a prepaid envelope that will be provided to you by the study staff.
* You will be given a pedometer to wear when you are ready to start your PA prescription.

Weeks 8, 26, 39, and 52 Study Visits:

For each of these study visits, the following tests and procedures will be performed:

* You will return the accelerometer at each visit for the study staff to review, and you will take it home at the end of each visit. The staff member will provide you with the device at your Week 8 visit and you will receive an envelope for return. The smartphone will also be given to you at Weeks 26 and 39, and you will be required to mail it back. For Week 52 you will receive the device 1 week before and return it at your Week 52 visit. You should tell a research staff member right away about any problems you may have using the smartphone.
* You will complete the computer-based survey.
* Your blood pressure will be measured.
* Your height, weight, and waistline will be measured.

You will receive phone calls between study visits to remind you to complete the questions on the smartphone.

At the Weeks 26 and 52 study visits, in addition to the tests and procedures listed above, you will complete the fitness test again and return the smartphone.

Length of Study:

You will remain in the study for up to 1 year. Your participation on this study will be over after you complete the study visit at Week 52.

Other Information:

You may be contacted by phone, mail, text messaging, and/or email at any time while you are taking part in this study to be reminded about the study visits. You will be asked to give the names and contact information of family members and/or friends for the study staff to contact in the event they cannot reach you first.

This is an investigational study.

Up to 300 participants will take part in this study. All will be enrolled at MD Anderson.

Social Contextual Influences on Physical Activity

Social, Contextual, and Environmental Determinants of Physical Activity in Sedentary Minority Adults

Physical Activity (PA) outcome measured at four time points post baseline (weeks 8, 26, 39, and 52)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Genetic Epidemiological Study of Lung Cancer in Taiwan and Clinical Applications	NCT00260871	Lung Cancer		-	National Health Research Institutes, Taiwan
Congenital Uterine Anomalies: Identifying Cancer Associations and Genetic and Environmental Factors to Improve Clinical Care	NCT04661072	Congenital Uter...		13 Years -	Yale University
Social Contextual Influences on Physical Activity	NCT01195337	Cancer Prevention Harm...	PA Prescription... Pedometer Newsletters	25 Years - 60 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for environmental factors