Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Familial Pancreatic Cancer

Pancreatic cancer patients or family member.

Questionnaire taking about 30-40 minutes to complete.

Questionnaire

Carrie Daniel-MacDougall, PHD

The goal of this research study is to investigate the role of genes that may point to a higher risk of developing pancreatic cancer.

Participants in this study will be part of a pancreatic cancer genetic epidemiology consortium (herein referred to as "PACGENE"), which includes researchers at these institutions: Mayo Clinic; Johns Hopkins University; Creighton University; University of Toronto Mount Sinai Hospital; Dana Farber; and Karmanos Cancer Institute. Participants have either been diagnosed with pancreatic cancer or are family members of pancreatic cancer patients.

Participants will be asked questions by a trained interviewer using an approved questionnaire. The topics will include demographic data (age, race, etc.), exposures, medical history data, family history of cancer and other conditions, and other lifestyle factors. It should take about 30-40 minutes to complete the questionnaire.

Participants in this study will also have about one and a half tablespoons of blood drawn. Blood that is collected will only be used by researchers involved in this study. If obtaining a blood sample is not possible, the study staff will ask for a saliva sample using an ORAGENE kit. Neither participants nor their physicians will receive individual reports of this research. Results will not be placed in the participant's health records. All information will be kept confidential and used only for this research.

There is a rare chance that a research team member could be accidentally exposed to your blood or body fluids. If that occurs, extra blood (about 2 teaspoons) may be drawn to test for infections such as hepatitis and HIV (the AIDS virus). An existing blood sample may be used for these tests instead. You will be told that your blood is being tested and the results of your test. Researchers will ask how you would like to receive the results, such as by phone or certified letter. The test results and your name, address, date of birth, and sex will be recorded in the confidential M. D. Anderson medical records.

If you test positive for hepatitis or HIV, the test results and your name, address, date of birth, and sex will be shared with appropriate health authorities as required by law. You will also be given a list of places in your area so that you can receive further testing and treatment.

For the protection of your privacy, the study staff has obtained a Certificate of Confidentiality from the National Institutes of Health. With this certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the certificate to resist any demands for information that would identify you, except as explained below.

The certificate cannot be used to resist a demand for information from personnel of the United State Government that is used for auditing or evaluation of Federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).

You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the certificate to withhold that information.

This is an investigational study. This study will include a total of 1,000 participants recruited at M. D. Anderson.

Pancreatic Cancer Genetic Epidemiology (PACGENE) Study

Data collection from patient response to 30-40 minute questionnaire and blood test.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Blood and Lymph Conditions

Symptoms and General Pathology

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Genetic Predisposition to Disease

Disease Susceptibility

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Interview lasting approximately 50 minutes.

Interview

Jian Gu, PHD

Little is known about the epidemiologic risk factors associated with the development of acute myelogenous leukemia (AML), and less is known about the role that genetic susceptibility plays in the development of AML. We propose to conduct a population-based study to investigate genetic susceptibility in adult AML patients, both de novo and treatment-related in a well-defined geographical area. Using a case-control design, we will prospectively enroll 400 patients from Texas and 800 healthy controls. Controls will be recruited using random digit dialing, and will be matched to the cases by age, gender, and ethnicity. Epidemiological and demographic information will be obtained through personal interviews, and will be integrated with clinical information, cytogenetic data, and genotypic markers. Blood specimens will be collected on all participants, who will be genotyped for markers associated with activation and detoxification of chemical carcinogens, including chemotherapy drugs. Polymorphisms in genes such as cytochrome p450 (CYP2E1), glutathione S-transferases (GSTT1, GSTM1, GSTP1), epoxide hydrolase (HYL1), NADPH-quinone oxidoreductase (NQO1), and myeloperoxidase (MPO) will be analyzed.

This study will provide insight into the role that these susceptibility markers, along with clinical epidemiological, and cytogenetic factors, play in the identification of people at risk of developing AML. Understanding how genetic predisposition and exogenous exposures interact to determine AML susceptibility will allow the development of prevention strategies in the future.

INFORMED CONSENTS FOR AML PATIENTS:

For this study, participant will be asked to complete a personal interview. During the interview, participant will be asked questions about participant's demographics (age, sex, etc.), any chemicals participant may have been exposed to, participant's medical history, family history of cancer, participant's diet, and participant's smoking and alcohol use histories. It should take around 50 minutes to complete the interview.

Participant will also have around 1 tablespoon of blood drawn for special tests. These tests will look for any biologic factors associated with AML.

The interview and the blood draw may be done during a regularly scheduled visit to M. D. Anderson, or may be scheduled at the time and place of participant's convenience.

Participant may be contacted at home by phone so that researchers can collect information about any changes in participant's health status.

This is an investigational study. Up to 1,200 participants will take part in this study.

INFORMED CONSENT FOR CONTROL SUBJECTS:

For this study, participant will be asked to complete a personal interview. During the interview, participant will be asked questions about participant's demographics (age, sex, etc.), any chemicals participant may have been exposed to, participant's medical history, family history of cancer, participant's diet, and participant's smoking and alcohol use histories. It should take around 50 minutes to complete the interview.

Participant will also have around 1 tablespoon of blood drawn for special tests. These tests will look for any biologic factors associated with AML. The interview and blood draw will be scheduled at the time and place of participant's convenience.

This is an investigational study. Up to 1,200 participants will take part in this study.

Blood sample collection to look for any biologic factors associated with AML.

Molecular Epidemiology of Acute Myelogenous Leukemia

Nutritional and Metabolic Diseases

Diabetes Mellitus, Type 2

Diabetes Mellitus

Pancreatitis

Pancreatitis, Chronic

Cysts

Pancreatic Cyst

Metabolic Diseases

Glucose Metabolism Disorders

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Blood Draw

This proposed project is designed to collect data and specimens from patients/subjects presenting to the University of Michigan with a disease affecting the pancreas (or specific control populations). This protocol is focused on collecting data, blood samples, and tissue on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts, pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy controls.

We are collecting up to 50 mls of blood for research purposes only. Plasma, serum and buffy coat are collected and stored according to strict SOPs.

The recently funded GI SPORE, here at the University of Michigan, is focused on pancreatic and colon diseases. This protocol is focused on collecting data, blood samples, and tissue on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts, pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy controls. A SPORE is an NCI-funded, Specialized Program in Research Excellence, with specific requirements. Those requirements include 4 projects with a clinical and a basic science Co-PI and several COREs, including a biospecimen core. Each project that has a human subjects component will require a separate protocol and IRB submission when those projects are to begin.

The specific populations we are recruiting are determined by the aims of project 2 and by the need to create a repository as part of the biospecimen core (please see the grant for details on the aims of these 2 projects).

A specially designed database is being built for this study to handle the data aspects. Our collaborators at Dartmouth College have significant experience in managing data as they have been our partners for our work in the EDRN (PI Brenner). Case report forms and other data collection tools have been developed and are being used to populate the database. All of the actual data will be completely deidentified per HIPAA regulations.

We intend to model the data and specimen collection on the model used by our work with the NCI-EDRN. This includes a customized database, the use of kits with pre-labled, bar-coded aliquots, and standardized data collection forms (CRFs).

Biospecimens for Identification of Diseases of the Pancreas.

Biospecimens for the Early Detection, Prevention, Diagnosis and Treatment of Diseases of the Pancreas.

To create a set of cases and controls to validate a novel glycoprotein panel for non-invasive or early detection of pancreatic cancer.

University of Michigan

Project manager

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Lung Neoplasms

Lung Diseases

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Mitogens

Control group of healthy subjects : simple blood analysis of EPCs

COPD: one initial blood sample and simple clinical follow-up

NSCLC: one initial blood sample and usual clinical follow-up

Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures

Boris MELLONI, Professor

Bone-marrow-derived progenitor cells (EPCS) play an important role in neovascularization and tumor growth. In lung cancer, angiogenesis is an important event in mechanisms of tumor proliferation and metastasis. Recent evidences suggest that EPCS can be recruited and differentiate in mature endothelial cells to form new blood vessels. The role of EPCs in NSCLC is unclear. In contrast, angiogenic drugs are proposed combined to systemic chemotherapy in NSCLC. The aim of this study is to identify EPCs in peripheral blood from patients with NSCLC, by comparison to Chronic Pulmonary Obstructive Disease (COPD), an inflammatory disease.

The aim of this study is to study blood circulating levels bone-marrow-derived progenitor cells (EPCS).

In a first phase, EPCs will be detected in healthy non-smokers volunteers to validate flow cytometry method (n=25). In addition, EPC will e characterized by primary cultures to analyze EPC-specific markers.

In a second phase, EPCs will detect in peripheral blood from 50 patients with Chronic Obstructive Pulmonary Disease (COPD) and 50 patients with non-small cell lung cancers (NSCLC). Primary cultures will be made to confirm EPCS isolation.

Methods: EPCs will be numerated by flow cytometry using CD133, CD146, CD34, CD45 and VEGFR2 antibodies. Primary cultures will be used to identify EPCs at 5-days culture by the same markers. In addition, for BPCO et NSCLC patients, Vascular endothelial cell growth factor (VEGF) concentration will be measured in peripheral sera by ELISA commercial test.

Overall survival will be analyzed for NSCLC in function of initial EPCs concentration. Correlation will be studied between initial VEGF serum concentration and EPCs level.

This study focus on the possibility that EPC determination in peripheral blood could be used as a surrogate marker of standard or antiangiogenic treatment in NSCLC.

Detection of Circulating Endothelial Progenitors Cells (EPCs) in Non-small Cell Lung Cancer (NSCLC)

Detection of Circulating Endothelial Progenitor Cells (EPCs) in Peripheral Blood From Non-small Cell Lung Cancer Patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pancreatic Cancer Genetic Epidemiology (PACGENE) Study	NCT00526578	Pancreatic Canc...	Questionnaire	18 Years -	M.D. Anderson Cancer Center
Molecular Epidemiology of Acute Myelogenous Leukemia	NCT00502983	Leukemia	Interview	18 Years -	M.D. Anderson Cancer Center
Biospecimens for Identification of Diseases of the Pancreas.	NCT01392027	Pancreatic Canc... Chronic Pancrea... Type II Diabete... Pancreatic Cyst... Healthy Control	Blood Draw	18 Years -	University of Michigan
Detection of Circulating Endothelial Progenitors Cells (EPCs) in Non-small Cell Lung Cancer (NSCLC)	NCT00826683	Non-Small Cell ... Chronic Obstruc...	Enumeration of ...	18 Years -	University Hospital, Limoges
Integrated Cancer Repository for Cancer Research	NCT02012699	Pancreatic Canc... Thyroid Cancer Lung Cancer Esophageal Canc... Thymus Cancer Colon Cancer Rectal Cancer Gastrointestina... Anal Cancer Bile Duct Cance... Duodenal Cancer Gallbladder Can... Gastric Cancer Liver Cancer Small Intestine... Peritoneal Surf... Familial Adenom... Lynch Syndrome Bladder Cancer Kidney Cancer Penile Cancer Prostate Cancer Testicular Canc... Ureter Cancer Urethral Cancer Hypopharyngeal ... Laryngeal Cance... Lip Cancer Oral Cavity Can... Nasopharyngeal ... Oropharyngeal C... Paranasal Sinus... Nasal Cavity Ca... Salivary Gland ... Skin Cancer Central Nervous... Central Nervous... Mesothelioma Breast Cancer Leukemia Melanoma Sarcoma Unknown Primary... Multiple Myelom... Ovarian Cancer Endometrial Can... Vaginal Cancer Neuroendocrine ... Plasma Cell Dys... Healthy Control		19 Years - 110 Years	University of Nebraska
Thermal Signature of Patients Undergoing Radiation Therapy	NCT00508313	Lung Cancer	Thermal Imaging	18 Years -	M.D. Anderson Cancer Center

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