CancerNCT00512642
Fluorescence Bronchoscopy and Molecular Characterization of Abnormal Bronchial Lesions: Novel Approaches for Early Detection of Lung Cancer in High Risk Patients
An observational study of Cancer, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
Despite intensive research efforts, there are still no simple and effective screening tools to detect early lung cancer. The majority of newly diagnosed patients have higher stage, often disseminated, non-resectable disease. Read more about this study
- Who is it for?
- Ages 35 to 150 years
- Conditions the study is for
- Cancer
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 1999to 19 Nov 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 35 to 150 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously resected stage I, II and IIIa lung cancers.
- Prior head and neck carcinoma.
- Bronchogenic carcinoma in a first degree relative.
- Smoking history of more than 15 pack-years current or past.
- Previously treated for Hodgkin's Disease.
- Abnormal sputum cytology with negative radiographs.
Who cannot join
- Patients with a current clinically detectable lung cancer.
- Age lower than 35 years.
- Pregnant or possibly pregnant.
- Patients with any contraindications to bronchoscopy.
- Severe underlying medical conditions such as unstable angina, uncompensated congestive heart failure, severe airway obstruction (FEV1) less than 0.8 L), or uncontrolled hypertension.
- Patients with a bleeding disorder or patients on anticoagulant therapy.
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- Use of chemopreventive drugs (retinoids) or photosensitizing agents (hematoporphyrin derivatives) within 3 months prior to initial bronchoscopy.
- Life expectancy less than 3 months.
- Patients who received chemotherapy or radiotherapy within 6 months prior to initial bronchoscopy.
Trial locations and contacts
1 site in 1 country.
United States1 site
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, 27709
About this study
Despite intensive research efforts, there are still no simple and effective screening tools to detect early lung cancer. The majority of newly diagnosed patients have higher stage, often disseminated, non-resectable disease. A better understanding of the natural biology and molecular abnormalities in early lung lesions may aid in the development of more effective screening tools. This study will investigate the effectiveness of bronchoscopy by white light (WL) alone and in combination with Lung Imaging Fluorescence Endoscopy (LIFE) for the detection of early lung lesions in patients with a high risk for developing lung cancer. LIFE is a FDA approved adjunct to WL bronchoscopy for the screening of lung cancer and this study will provide a standardized setting in which a direct comparison between a combination of WL and LIFE versus traditional WL bronchoscopy can be made.
In addition, the study will set the stage for the collection of a unique set of biopsy specimens that will be used to learn more about the natural biology and the molecular changes in early lung lesions. We will study abnormalities in p53 by immunohistochemistry and by molecular analyses. The p53 results will be compared with histological grade and with genomic instability. Measures for genomic instability will be the loss of chromosomal information and cellular aneuploidy. Recent advances in molecular pathology, such as the development of Laser Capture Microdissection (LCM), have made the molecular profiling of these extremely small lesions feasible. The information obtained by these techniques will be used for comparison with clinical and exposure information. Future plans include the culturing of bronchial epithelial cells to study genomic instability in the multistep process of cancer progression. It is our hope that the application of these new technologies will improve the early detection of human lung cancer and provide insight into the natural biology and molecular changes of early lung lesions which may progress towards overt cancers.
Read the detailed description
Despite intensive research efforts, there are still no simple and effective screening tools to detect early lung cancer. The majority of newly diagnosed patients have higher stage, often disseminated, non-resectable disease. A better understanding of the natural biology and molecular abnormalities in early lung lesions may aid in the development of more effective screening tools. The Lung Imaging Fluorescence Endoscopy (LIFE) is FDA approved as an adjunct to WL bronchoscopy for the screening of lung cancer.
Using the LIFE unit, this study will set the stage for the collection of a unique set of biopsy specimens that will be used to learn more about the natural biology and molecular changes in early lung lesions. We will study abnormalities in p53 by immunohistochemistry and by molecular analyses. The p53 results will be compared with histological grade and with genomic instability. Measures for genomic instability will be the loss of chromosomal information and cellular aneuploidy. Recent advances in molecular pathology, such as the development of Laser Capture Microdissection (LCM), have made the molecular profiling of these extremely small lesions feasible. The information obtained by these techniques will be used for comparison with clinical and exposure information. Future plans include the culturing of bronchial epithelial cells to study genomic instability in the multistep process of cancer progression. It is our hope that the application of these new technologies will improve the early detection of human lung cancer and provide insight into the natural biology and molecular changes of early lung lesions which may progress towards overt cancers.
- Conditions
- Cancer
- Keywords
- Cancer, Lymphocytes, Genetics
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients at increased risk of lung cancer | Patients at increased risk of lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic abnormalities
histologic or genetic change at follow-up bronchoscopy at 6 or 12 months
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study start29 Jul 1999
- Study completion19 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jack Taylor, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512642
- Sponsor's protocol ID
- 9999999040
- Other IDs
- OH99-E-N040
- Status last verified
- 19 Nov 2019
- First submitted
- 7 Aug 2007
- Last updated
- 21 Nov 2019
- Results posted
- No
Publications
Vogelstein B, Fearon ER, Hamilton SR, Kern SE, Preisinger AC, Leppert M, Nakamura Y, White R, Smits AM, Bos JL. Genetic alterations during colorectal-tumor development. N Engl J Med. 1988 Sep 1;319(9):525-32. doi: 10.1056/NEJM198809013190901.
PubMed 2841597Lam S, MacAulay C, Hung J, LeRiche J, Profio AE, Palcic B. Detection of dysplasia and carcinoma in situ with a lung imaging fluorescence endoscope device. J Thorac Cardiovasc Surg. 1993 Jun;105(6):1035-40.
PubMed 8501931Gordenin DA, Resnick MA. Yeast ARMs (DNA at-risk motifs) can reveal sources of genome instability. Mutat Res. 1998 May 25;400(1-2):45-58. doi: 10.1016/s0027-5107(98)00047-5.
PubMed 9685581
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence Bronchoscopy and Molecular Characterization of Abnormal Bronchial Lesions: Novel Approaches for Early Detection of Lung Cancer in High Risk Patients
- ClinicalTrials.gov ID
- NCT00512642
- Acronym / sponsor ID
- 9999999040
- Conditions
- Cancer
- Keywords
- Cancer, Lymphocytes, Genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 29 Jul 1999
- Study completion
- 19 Nov 2019
- First posted
- 8 Aug 2007 (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.
Despite intensive research efforts, there are still no simple and effective screening tools to detect early lung cancer. The majority of newly diagnosed patients have higher stage, often disseminated, non-resectable disease. A better understanding of the natural biology and molecular abnormalities in early lung lesions may aid in the development of more effective screening tools. This study will investigate the effectiveness of bronchoscopy by white light (WL) alone and in combination with Lung Imaging Fluorescence Endoscopy (LIFE) for the detection of early lung lesions in patients with a high risk for developing lung cancer. LIFE is a FDA approved adjunct to WL bronchoscopy for the screening of lung cancer and this study will provide a standardized setting in which a direct comparison between a combination of WL and LIFE versus traditional WL bronchoscopy can be made.
In addition, the study will set the stage for the collection of a unique set of biopsy specimens that will be used to learn more about the natural biology and the molecular changes in early lung lesions. We will study abnormalities in p53 by immunohistochemistry and by molecular analyses. The p53 results will be compared with histological grade and with genomic instability. Measures for genomic instability will be the loss of chromosomal information and cellular aneuploidy. Recent advances in molecular pathology, such as the development of Laser Capture Microdissection (LCM), have made the molecular profiling of these extremely small lesions feasible. The information obtained by these techniques will be used for comparison with clinical and exposure information. Future plans include the culturing of bronchial epithelial cells to study genomic instability in the multistep process of cancer progression. It is our hope that the application of these new technologies will improve the early detection of human lung cancer and provide insight into the natural biology and molecular changes of early lung lesions which may progress towards overt cancers.
Detailed description
Despite intensive research efforts, there are still no simple and effective screening tools to detect early lung cancer. The majority of newly diagnosed patients have higher stage, often disseminated, non-resectable disease. A better understanding of the natural biology and molecular abnormalities in early lung lesions may aid in the development of more effective screening tools. The Lung Imaging Fluorescence Endoscopy (LIFE) is FDA approved as an adjunct to WL bronchoscopy for the screening of lung cancer.
Using the LIFE unit, this study will set the stage for the collection of a unique set of biopsy specimens that will be used to learn more about the natural biology and molecular changes in early lung lesions. We will study abnormalities in p53 by immunohistochemistry and by molecular analyses. The p53 results will be compared with histological grade and with genomic instability. Measures for genomic instability will be the loss of chromosomal information and cellular aneuploidy. Recent advances in molecular pathology, such as the development of Laser Capture Microdissection (LCM), have made the molecular profiling of these extremely small lesions feasible. The information obtained by these techniques will be used for comparison with clinical and exposure information. Future plans include the culturing of bronchial epithelial cells to study genomic instability in the multistep process of cancer progression. It is our hope that the application of these new technologies will improve the early detection of human lung cancer and provide insight into the natural biology and molecular changes of early lung lesions which may progress towards overt cancers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients at increased risk of lung cancer | – | –Patients at increased risk of lung cancer |
Who may qualify
- Ages
- 35 to 150 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Previously resected stage I, II and IIIa lung cancers.
- Prior head and neck carcinoma.
- Bronchogenic carcinoma in a first degree relative.
- Smoking history of more than 15 pack-years current or past.
- Previously treated for Hodgkin's Disease.
Key exclusion criteria (9 listed)
- Patients with a current clinically detectable lung cancer.
- Age lower than 35 years.
- Pregnant or possibly pregnant.
- Patients with any contraindications to bronchoscopy.
- Severe underlying medical conditions such as unstable angina, uncompensated congestive heart failure, severe airway obstruction (FEV1) less than 0.8 L), or uncontrolled hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic abnormalities
Time frame: 6 months, 12 months
histologic or genetic change at follow-up bronchoscopy at 6 or 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Background: PubMed 2841597Vogelstein B, Fearon ER, Hamilton SR, Kern SE, Preisinger AC, Leppert M, Nakamura Y, White R, Smits AM, Bos JL. Genetic alterations during colorectal-tumor development. N Engl J Med. 1988 Sep 1;319(9):525-32. doi: 10.1056/NEJM198809013190901.
- Background: PubMed 8501931Lam S, MacAulay C, Hung J, LeRiche J, Profio AE, Palcic B. Detection of dysplasia and carcinoma in situ with a lung imaging fluorescence endoscope device. J Thorac Cardiovasc Surg. 1993 Jun;105(6):1035-40.
- Background: PubMed 9685581Gordenin DA, Resnick MA. Yeast ARMs (DNA at-risk motifs) can reveal sources of genome instability. Mutat Res. 1998 May 25;400(1-2):45-58. doi: 10.1016/s0027-5107(98)00047-5.
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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.
Jack Taylor, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
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 Cancer, run by National Institute of Environmental Health Sciences (NIEHS) 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 21 Nov 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Genetic abnormalities (time frame: 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00512642, which also lists 3 linked publications.
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 21 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.