Emphysema/COPD Research Registry
| Status: | Recruiting |
|---|---|
| Conditions: | Bronchitis, Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 7/1/2018 |
| Start Date: | August 2000 |
| End Date: | July 2030 |
| Contact: | Paula Consolaro, CCRC |
| Email: | consolaropj@upmc.edu |
| Phone: | 412-692-4800 |
Emphysema Research Registry; Screening Study and Genetic Testing
The Comprehensive Lung Center (CLC) at the University of Pittsburgh Medical Center (UPMC
Health System) provides patients with any type of breathing or lung disorder a full range of
diagnostic and therapeutic services. The Emphysema/COPD Research Center (ECRC) is a specialty
clinic, within this center, that attempts to advance the understanding of emphysema and to
evaluate new therapies for patients with emphysema. The Emphysema Research Registry will
enable pulmonary research physicians to: 1) gather information and create a research registry
of people who have been diagnosed with emphysema; 2) utilize this research registry with the
purpose of conducting research that attempts to advance the understanding of emphysema and to
evaluate new therapies; and, 3) use the research registry to identify potential candidates
for future research programs. These aims will be achieved by the collection of DNA (genetic
material)for analysis and storage in addition to pulmonary function tests and other medical
information.
Health System) provides patients with any type of breathing or lung disorder a full range of
diagnostic and therapeutic services. The Emphysema/COPD Research Center (ECRC) is a specialty
clinic, within this center, that attempts to advance the understanding of emphysema and to
evaluate new therapies for patients with emphysema. The Emphysema Research Registry will
enable pulmonary research physicians to: 1) gather information and create a research registry
of people who have been diagnosed with emphysema; 2) utilize this research registry with the
purpose of conducting research that attempts to advance the understanding of emphysema and to
evaluate new therapies; and, 3) use the research registry to identify potential candidates
for future research programs. These aims will be achieved by the collection of DNA (genetic
material)for analysis and storage in addition to pulmonary function tests and other medical
information.
The Emphysema/COPD Research Center will enroll up to 3000 subjects at the University of
Pittsburgh. The experimental procedures that will be conducted as a part of the Emphysema
Research Registry include gathering basic personal information (e.g., name, address, phone
number, etc.), asking basic screening questions (which may involve the examination of past,
current, and future medical records with an authorized release and the collection of
personally identifiable medical record information), completing two breathing questionnaires,
performing screening lung function tests to determine breathing capacity and blood oxygen
levels, to have blood drawn, to complete a measurement of leg muscle strength, and to have a
measurement of body fat.
The breathing questionnaires are known as the St. George's Respiratory Questionnaire (SGRQ),
the Medical Research Council Dyspnea Questionnaire (MRCDQ) and COPD assessment Test (CAT).
These are paper and pencil questionnaires that inquire about respiratory symptoms, quality of
life, and shortness of breath.
Breathing tests are routine clinical tests that measure lung function; spirometry (measures
the ability to move air in and out of the lungs), lung volumes (measures the amount of air
trapped in the lungs), diffusing capacity (measures how well lungs transfer oxygen to blood),
forced oscillometry testing (measures respiratory resistance), and pulse oximetry (measures
blood oxygen levels). In addition, subjects will be asked to inhale two puffs of albuterol,
which is an inhaled medicine (bronchodilator) that may open up breathing passages, and to
repeat some of the breathing tests.
The initial blood work will consist of two samples. The first sample will examine routine
tests such as blood chemistries (such as sodium and potassium), hemoglobin, blood count, and
blood sugar. The second sample will involve DNA testing. The DNA in your cells is what
determines your genetic makeup. The DNA studies that will be done for this Research Registry
will be restricted to studies of genetics associated with COPD. The total amount of blood
drawn will be 5 tablespoons or less. A separate consent form, Consent 2, addresses this
second blood draw in detail. In addition to the initial blood draw, the participant will be
asked to contact the center when they are experiencing a COPD exacerbation (increased cough,
change in sputum, shortness of breath, etc.). At that time, the participant will be asked to
either come to the clinic or allow a study coordinator to go to them and obtain an additional
sample of blood. The total amount of this sample will be less than 2 tablespoons. Biologic
samples (serum plasma) will be under the control of the principal investigator of this
research project. To protect confidentiality, all personal identifiers (i.e. name, social
security number, birth date) will be removed (de-identified) and replaced with a specific
code number. The information linking these code numbers to the corresponding subjects'
identities will be kept in a separate, secure location. The investigators on this study will
keep the samples indefinitely. Biological samples may (or will or will not) be given to
investigators outside of UPMC or may be utilized in future studies.
Leg muscle strength will be measured using an isokinetic dynamometer (MERAC, Universal, Cedar
Rapids, IA) in all subjects. Strength will be measured as peak angular force (Newton-m)
generated at an angular velocity of 60º/sec during three maximal continuous repetitions.
Subjects will be provided standardized instructions and perform practice maneuvers to ensure
smooth torque curves.
Body fat testing, also known as Fat Free Mass (FFM) testing, will be measured using a single
frequency bioelectrical impedance method in the supine position, as the mean of two
measurements (one on each side of the body), using equipment previously used by the Emphysema
Research Center (BIA 101/s RJL-Systems, Detroit, MI). The FFM index will be calculated by
dividing FFM by height in meters2 as an accurate measure of muscle mass.
All study procedures including Informed Consent, breathing questionnaires, breathing tests,
blood work, leg muscle strength testing, and body fat testing will be conducted at the
Emphysema/COPD Research Center, located in Suite 1211, Kaufmann Building. The informed
consent usually takes 30 minutes, the Patient Data Form will require 5 minutes to fill out,
the two breathing questionnaires will take 15 minutes, the screening lung function tests
usually take less than 1 hour, the blood work will take 15 minutes, the leg muscle strength
testing will take 10 minutes, and the body fat testing will take 5 minutes.
The information from each subject will be entered into the Emphysema Research Registry. The
information will be held here until a research protocol is developed or an outside
investigator approaches Dr. Frank C. Sciurba. The information gathered (basic personal
information, basic screening questions, breathing questionnaires, screening lung function
tests, blood work, leg muscle strength, and body fat) will be updated periodically, based on
investigator need.
Pittsburgh. The experimental procedures that will be conducted as a part of the Emphysema
Research Registry include gathering basic personal information (e.g., name, address, phone
number, etc.), asking basic screening questions (which may involve the examination of past,
current, and future medical records with an authorized release and the collection of
personally identifiable medical record information), completing two breathing questionnaires,
performing screening lung function tests to determine breathing capacity and blood oxygen
levels, to have blood drawn, to complete a measurement of leg muscle strength, and to have a
measurement of body fat.
The breathing questionnaires are known as the St. George's Respiratory Questionnaire (SGRQ),
the Medical Research Council Dyspnea Questionnaire (MRCDQ) and COPD assessment Test (CAT).
These are paper and pencil questionnaires that inquire about respiratory symptoms, quality of
life, and shortness of breath.
Breathing tests are routine clinical tests that measure lung function; spirometry (measures
the ability to move air in and out of the lungs), lung volumes (measures the amount of air
trapped in the lungs), diffusing capacity (measures how well lungs transfer oxygen to blood),
forced oscillometry testing (measures respiratory resistance), and pulse oximetry (measures
blood oxygen levels). In addition, subjects will be asked to inhale two puffs of albuterol,
which is an inhaled medicine (bronchodilator) that may open up breathing passages, and to
repeat some of the breathing tests.
The initial blood work will consist of two samples. The first sample will examine routine
tests such as blood chemistries (such as sodium and potassium), hemoglobin, blood count, and
blood sugar. The second sample will involve DNA testing. The DNA in your cells is what
determines your genetic makeup. The DNA studies that will be done for this Research Registry
will be restricted to studies of genetics associated with COPD. The total amount of blood
drawn will be 5 tablespoons or less. A separate consent form, Consent 2, addresses this
second blood draw in detail. In addition to the initial blood draw, the participant will be
asked to contact the center when they are experiencing a COPD exacerbation (increased cough,
change in sputum, shortness of breath, etc.). At that time, the participant will be asked to
either come to the clinic or allow a study coordinator to go to them and obtain an additional
sample of blood. The total amount of this sample will be less than 2 tablespoons. Biologic
samples (serum plasma) will be under the control of the principal investigator of this
research project. To protect confidentiality, all personal identifiers (i.e. name, social
security number, birth date) will be removed (de-identified) and replaced with a specific
code number. The information linking these code numbers to the corresponding subjects'
identities will be kept in a separate, secure location. The investigators on this study will
keep the samples indefinitely. Biological samples may (or will or will not) be given to
investigators outside of UPMC or may be utilized in future studies.
Leg muscle strength will be measured using an isokinetic dynamometer (MERAC, Universal, Cedar
Rapids, IA) in all subjects. Strength will be measured as peak angular force (Newton-m)
generated at an angular velocity of 60º/sec during three maximal continuous repetitions.
Subjects will be provided standardized instructions and perform practice maneuvers to ensure
smooth torque curves.
Body fat testing, also known as Fat Free Mass (FFM) testing, will be measured using a single
frequency bioelectrical impedance method in the supine position, as the mean of two
measurements (one on each side of the body), using equipment previously used by the Emphysema
Research Center (BIA 101/s RJL-Systems, Detroit, MI). The FFM index will be calculated by
dividing FFM by height in meters2 as an accurate measure of muscle mass.
All study procedures including Informed Consent, breathing questionnaires, breathing tests,
blood work, leg muscle strength testing, and body fat testing will be conducted at the
Emphysema/COPD Research Center, located in Suite 1211, Kaufmann Building. The informed
consent usually takes 30 minutes, the Patient Data Form will require 5 minutes to fill out,
the two breathing questionnaires will take 15 minutes, the screening lung function tests
usually take less than 1 hour, the blood work will take 15 minutes, the leg muscle strength
testing will take 10 minutes, and the body fat testing will take 5 minutes.
The information from each subject will be entered into the Emphysema Research Registry. The
information will be held here until a research protocol is developed or an outside
investigator approaches Dr. Frank C. Sciurba. The information gathered (basic personal
information, basic screening questions, breathing questionnaires, screening lung function
tests, blood work, leg muscle strength, and body fat) will be updated periodically, based on
investigator need.
Inclusion Criteria:
- Patients would be required to have COPD based on at least one of the following:
clinical history, pulmonary function results, or radiographic results.
Exclusion Criteria:
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
Principal Investigator: Frank C. Sciurba, MD
Phone: 412-692-4800
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