Chronic Obstructive Pulmonary DiseaseNCT01982149
Incorporation of Genetic Expression of Airway Epithelium With CT Screening for Lung Cancer
An observational study of Chronic Obstructive Pulmonary Disease and COPD, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Lung cancer, largely the result of cigarette smoking, is the leading cause of cancer death in the United States, killing over 160,000 people in 2010, more than breast, colorectal, and prostate cancer combined. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- What is being tested?
- Group 1, Group 2 and Group 3
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: New York Metropolitan area residents
Who may be able to join
- HEALTHY VOLUNTEER RESEARCH SUBJECTS
- All study subjects should be able to provide informed consent
- Males or females ages 18 years and older
- Must provide HIV informed consent
- VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE
- Must provide informed consent
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- Males and females age 18 years and older
- Lung disease proven by at least one of the following: symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and/or (6) diseases of organs with known association with lung disease
- Must provide HIV informed consent
Who cannot join
- HEALTHY VOLUNTEER RESEARCH SUBJECTS
- Individuals not deemed in good overall health by the investigator will not be accepted into the study.
- Habitual use of drugs and/or alcohol within the past six months (Acceptable: - Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria).
- Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study.
- Individuals with allergies to atropine or any local anesthetic will not be accepted into the study.
- Individuals with allergies to pilocarpine, isoproterenol, terbutaline, atropine or aminophylline will not be accepted into the study.
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- Females who are pregnant or nursing will not be accepted into the study
- VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE
- Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, pilocarpine, isoproterenol, terbutaline, aminophylline, or any local anesthetic will not be included in the study.
- Habitual use of drugs and/or alcohol within the past six months (Acceptable: Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria)
- Females who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine
New York, New York, 10065
About this study
Lung cancer, largely the result of cigarette smoking, is the leading cause of cancer death in the United States, killing over 160,000 people in 2010, more than breast, colorectal, and prostate cancer combined. Since only 10% of heavy smokers develop lung cancer and 20% of lung cancers develop in nonsmokers, it is thought that genetic predisposition plays an important role. This study proposes to examine the genetic correlation between nasal and bronchial epithelium and to identify a patient's risk for lung cancer earlier.
Read the detailed description
Lung cancer, largely the result of cigarette smoking, is the leading cause of cancer death in the United States, killing over 160,000 people in 2010, more than breast, colorectal, and prostate cancer combined. Since only 10% of heavy smokers develop lung cancer and 20% of lung cancers develop in nonsmokers, it is thought that genetic predisposition plays an important role.
Without screening, lung cancer is only detected at an early stage 10% of the time, translating into a 7% cure rate. Published studies of screening for lung cancer using CT scans show that it is detectable at an early stage 85% of the time, translating into a cure rate over 60%. However, in a sample population of 1000 smokers over the age of 60 (high risk individuals), 233 will have suspicious abnormalities on CT scans, but only 27 had lung cancer. Two concerns are apparent. First, among the 233 individuals with suspicious abnormalities on CT, how does one choose the ones suspicious enough for biopsy, surgery, or other invasive procedures? Generally, follow-up CT scans over several months are used to assess the abnormalities for growth, since growth is a characteristic of malignancy. Unfortunately, repeated CT scans involve financial cost and potential radiation risk. An additional technique which is able to predict predisposition to lung cancer, if combined with the ability of CT scans to detect abnormalities in real time, could prove to be a powerful platform to efficiently screen for lung cancer and reduce its mortality.
Lung cancer develops as a consequence of a series of genetic injuries to the cells lining the airways which cause these bronchial cells to grow in a malignant manner, unchecked, resistant to normal homeostatic controls. By studying the gene expression signature of airway (bronchial) lining cells, differences are observed between normal nonsmokers, individuals exposed to smoke second-hand, and smokers who have developed COPD (chronic bronchitis and emphysema). Some genetic changes in bronchial lining cells near a lung cancer are specific to lung cancer --- the "field effect." Obtaining bronchial lining cells for genetic analysis requires an invasive and expensive procedure, fiberoptic bronchoscopy, and therefore bronchoscopically acquired bronchial lining cells are not suitable for screening of the public for lung cancer.
The lining cells of the nose, the nasal epithelium, which is part of the human airway, have many similarities to bronchial epithelium, but they are much more accessible. A gentle scraping of the nasal lining involves no risk to the patient, less cost, and, it is hoped, will provide the same genetic information as the bronchial lining cells.
This study proposes to examine the genetic correlation between nasal and bronchial epithelium in the hopes of developing an office-based test to identify a patient's risk for lung cancer. It is hoped that the genetic analysis of nasal epithelium may be combined with the other risk factors for lung cancer such as cigarette smoking, age over 50 years, and an obstructive ventilatory impairment noted on pulmonary function tests to find the ideal (or enriched) population to screen with CT to detect early lung cancer, thus reducing the financial cost, radiation exposure, and risk of invasive procedures to a minimum, furthering the ultimate goal of "personalized medicine."
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Being tested
- Group 1, Group 2, Group 3
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Smokers, Nonsmokers
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Genetic
Perform gene expression studies of airway epithelium to correlate findings in the gene expression of nasal bronchial epithelium
Group 2Genetic
Correlate gene expression data from nasal and bronchial epithelium
Group 3Genetic
Correlated nasal epithelial gene expression with the ultimate diagnosis (by biopsy or surgery)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Non-smokers (n=20) Receives: Genetic: Group 1 | |
| Group 2 | Non-smokers (n=20), Smokers (n=20) and Individuals with lung cancer (n=20) Receives: Genetic: Group 2 | |
| Group 3 | Subjects with abnormalities (nodules) detected on CT (n=20) Receives: Genetic: Group 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the correlation among gene expression levels between nasal and bronchial epithelium on an individual gene and multivariate basis
Measure the correlation among gene expression levels between nasal and bronchial epithelium on an individual gene and multivariate basis
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startJun 2014
- Primary completionMay 2019
- Study completionMay 2019
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald G Crystal, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982149
- Sponsor's protocol ID
- 1305013973
- Other IDs
- Weill Cornell Medical College
- Status last verified
- Jul 2020
- First submitted
- 25 Oct 2013
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporation of Genetic Expression of Airway Epithelium With CT Screening for Lung Cancer
- ClinicalTrials.gov ID
- NCT01982149
- Acronym / sponsor ID
- 1305013973
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Smokers, Nonsmokers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer, largely the result of cigarette smoking, is the leading cause of cancer death in the United States, killing over 160,000 people in 2010, more than breast, colorectal, and prostate cancer combined. Since only 10% of heavy smokers develop lung cancer and 20% of lung cancers develop in nonsmokers, it is thought that genetic predisposition plays an important role. This study proposes to examine the genetic correlation between nasal and bronchial epithelium and to identify a patient's risk for lung cancer earlier.
Detailed description
Lung cancer, largely the result of cigarette smoking, is the leading cause of cancer death in the United States, killing over 160,000 people in 2010, more than breast, colorectal, and prostate cancer combined. Since only 10% of heavy smokers develop lung cancer and 20% of lung cancers develop in nonsmokers, it is thought that genetic predisposition plays an important role.
Without screening, lung cancer is only detected at an early stage 10% of the time, translating into a 7% cure rate. Published studies of screening for lung cancer using CT scans show that it is detectable at an early stage 85% of the time, translating into a cure rate over 60%. However, in a sample population of 1000 smokers over the age of 60 (high risk individuals), 233 will have suspicious abnormalities on CT scans, but only 27 had lung cancer. Two concerns are apparent. First, among the 233 individuals with suspicious abnormalities on CT, how does one choose the ones suspicious enough for biopsy, surgery, or other invasive procedures? Generally, follow-up CT scans over several months are used to assess the abnormalities for growth, since growth is a characteristic of malignancy. Unfortunately, repeated CT scans involve financial cost and potential radiation risk. An additional technique which is able to predict predisposition to lung cancer, if combined with the ability of CT scans to detect abnormalities in real time, could prove to be a powerful platform to efficiently screen for lung cancer and reduce its mortality.
Lung cancer develops as a consequence of a series of genetic injuries to the cells lining the airways which cause these bronchial cells to grow in a malignant manner, unchecked, resistant to normal homeostatic controls. By studying the gene expression signature of airway (bronchial) lining cells, differences are observed between normal nonsmokers, individuals exposed to smoke second-hand, and smokers who have developed COPD (chronic bronchitis and emphysema). Some genetic changes in bronchial lining cells near a lung cancer are specific to lung cancer --- the "field effect." Obtaining bronchial lining cells for genetic analysis requires an invasive and expensive procedure, fiberoptic bronchoscopy, and therefore bronchoscopically acquired bronchial lining cells are not suitable for screening of the public for lung cancer.
The lining cells of the nose, the nasal epithelium, which is part of the human airway, have many similarities to bronchial epithelium, but they are much more accessible. A gentle scraping of the nasal lining involves no risk to the patient, less cost, and, it is hoped, will provide the same genetic information as the bronchial lining cells.
This study proposes to examine the genetic correlation between nasal and bronchial epithelium in the hopes of developing an office-based test to identify a patient's risk for lung cancer. It is hoped that the genetic analysis of nasal epithelium may be combined with the other risk factors for lung cancer such as cigarette smoking, age over 50 years, and an obstructive ventilatory impairment noted on pulmonary function tests to find the ideal (or enriched) population to screen with CT to detect early lung cancer, thus reducing the financial cost, radiation exposure, and risk of invasive procedures to a minimum, furthering the ultimate goal of "personalized medicine."
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: Group 1Non-smokers (n=20) |
| Group 2 | – | Genetic: Group 2Non-smokers (n=20), Smokers (n=20) and Individuals with lung cancer (n=20) |
| Group 3 | – | Genetic: Group 3Subjects with abnormalities (nodules) detected on CT (n=20) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- New York Metropolitan area residents
Key inclusion criteria (9 listed)
- HEALTHY VOLUNTEER RESEARCH SUBJECTS
- All study subjects should be able to provide informed consent
- Males or females ages 18 years and older
- Must provide HIV informed consent
- VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE
Key exclusion criteria (11 listed)
- HEALTHY VOLUNTEER RESEARCH SUBJECTS
- Individuals not deemed in good overall health by the investigator will not be accepted into the study.
- Habitual use of drugs and/or alcohol within the past six months (Acceptable: - Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria).
- Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study.
- Individuals with allergies to atropine or any local anesthetic will not be accepted into the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1Perform gene expression studies of airway epithelium to correlate findings in the gene expression of nasal bronchial epithelium | Genetic | Group 1 |
| Group 2Correlate gene expression data from nasal and bronchial epithelium | Genetic | Group 2 |
| Group 3Correlated nasal epithelial gene expression with the ultimate diagnosis (by biopsy or surgery) | Genetic | Group 3 |
Primary outcome
Measure the correlation among gene expression levels between nasal and bronchial epithelium on an individual gene and multivariate basis
Time frame: One year
Measure the correlation among gene expression levels between nasal and bronchial epithelium on an individual gene and multivariate basis
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald G Crystal, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and COPD, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the correlation among gene expression levels between nasal and bronchial epithelium on an individual gene and multivariate basis (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.