Lung CancerNCT00733252
Optical Coherence Tomography of the Airway for Lung Cancer or Lung Disease
An observational study of Lung Cancer and Malignant Mesothelioma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Diagnostic procedures, such as optical coherence tomography, may help find and diagnose lung cancer or precancerous cells. PURPOSE: This phase I trial is studying how well optical coherence tomography of the airway works in detecting abnormal cells in patients undergoing surgery for lung cancer or lung… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer, Malignant Mesothelioma, Metastatic Cancer
- What is being tested?
- bronchoscopic and lung imaging studies, diagnostic bronchoscopy and histopathologic examination
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Feb 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care clinic
DISEASE CHARACTERISTICS:
- Undergoing pneumonectomy or lobectomy for malignant or benign lung processes
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Optical Coherence Tomography of Human Airways
RATIONALE: Diagnostic procedures, such as optical coherence tomography, may help find and diagnose lung cancer or precancerous cells.
PURPOSE: This phase I trial is studying how well optical coherence tomography of the airway works in detecting abnormal cells in patients undergoing surgery for lung cancer or lung disease.
Read the detailed description
OBJECTIVES:
- Correlate optical coherence tomography images of the airway with airway histology.
- Develop an imaging technique to detect premalignant airway epithelial changes (carcinoma in situ, dysplasia) to study the transformation process as well as intervene and prevent the development of lung cancer.
OUTLINE: Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery. All imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis.
- Conditions
- Lung Cancer, Malignant Mesothelioma, Metastatic Cancer, Nonmalignant Neoplasm, Precancerous Condition
- Being tested
- bronchoscopic and lung imaging studies, diagnostic bronchoscopy, histopathologic examination, optical coherence tomography
- Keywords
- non-small cell lung cancer, small cell lung cancer, benign respiratory tract neoplasm, lung papilloma, recurrent respiratory papillomatosis, squamous lung dysplasia, malignant mesothelioma, pulmonary carcinoid tumor, lung metastases
- Medical subject headings
- Lung Neoplasms, Mesothelioma, Malignant, Neoplasm Metastasis, Neoplasms, Precancerous Conditions, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Recurrent respiratory papillomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopic and lung imaging studiesProcedure or surgery
Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery.
diagnostic bronchoscopyProcedure or surgery
Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery.
histopathologic examinationProcedure or surgery
All imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis.
optical coherence tomographyProcedure or surgery
Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of optical coherence tomography images of the airway with airway histology
Measured: This study will involve discarded tissue from 10 subjects with pathology specimens over 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 Aug 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2011
- Study completionFeb 2011
Why it stopped: Low interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rana Hejal, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733252
- Sponsor's protocol ID
- CASE1508
- Other IDs
- P30CA043703, CASE1508, CASE-1508-CC483
- Status last verified
- Oct 2015
- First submitted
- 12 Aug 2008
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography of Human Airways
- ClinicalTrials.gov ID
- NCT00733252
- Acronym / sponsor ID
- CASE1508
- Conditions
- Lung Cancer, Malignant Mesothelioma, Metastatic Cancer, Nonmalignant Neoplasm, Precancerous Condition
- Keywords
- non-small cell lung cancer, small cell lung cancer, benign respiratory tract neoplasm, lung papilloma, recurrent respiratory papillomatosis, squamous lung dysplasia, malignant mesothelioma, pulmonary carcinoid tumor
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Low interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 13 Aug 2008 (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.
RATIONALE: Diagnostic procedures, such as optical coherence tomography, may help find and diagnose lung cancer or precancerous cells.
PURPOSE: This phase I trial is studying how well optical coherence tomography of the airway works in detecting abnormal cells in patients undergoing surgery for lung cancer or lung disease.
Detailed description
OBJECTIVES:
- Correlate optical coherence tomography images of the airway with airway histology.
- Develop an imaging technique to detect premalignant airway epithelial changes (carcinoma in situ, dysplasia) to study the transformation process as well as intervene and prevent the development of lung cancer.
OUTLINE: Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery. All imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
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 |
|---|---|---|
| bronchoscopic and lung imaging studiesBronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery. | Procedure or surgery | – |
| diagnostic bronchoscopyBronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery. | Procedure or surgery | – |
| histopathologic examinationAll imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis. | Procedure or surgery | – |
| optical coherence tomographyBronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery. | Procedure or surgery | – |
Primary outcome
Correlation of optical coherence tomography images of the airway with airway histology
Time frame: This study will involve discarded tissue from 10 subjects with pathology specimens over one year.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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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.
Rana Hejal, MD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
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 Lung Cancer and Malignant Mesothelioma, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Oct 2015. 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 withdrawn before enrolling participants, so there are no results.
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?
Correlation of optical coherence tomography images of the airway with airway histology (time frame: This study will involve discarded tissue from 10 subjects with pathology specimens over 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 2 Oct 2015.