Lung CancerNCT00581503
Early Detection and Staging of Endobronchial Lung and Pleural Cancer, Airway Injury, and Prostate Cancer
An observational study of Lung Cancer and Pleural Cancer, run by University of California, Irvine at 2 sites in United States.
Trial summary
This study has been designed to utilize already obtained biopsy specimens for investigation of the utility of a new, non-invasive optical diagnostic technique. The study will allow a careful correlation between the Optical coherence tomography findings and conventional histology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Pleural Cancer, Prostate Cancer
- What is being tested?
- diagnostic
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2007to Jul 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Study Population will be identified at UCIMC, who is scheduled for prostatectomy, endobronchial, transbronchial, and pleural biopsy will be recurited to participate in the study.
Who may be able to join
- Adult 18 years and older
- Having procedure of endobronchial, transbronchial, and / or pleural biopsy
Who cannot join
- Currently participating in any other investigational drug or device evaluation.
- Currently taking drugs that are sensitive to light.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pulmonary and Critical Care Medicine, UCI Medical Center
Orange, California, 92868
Urology department, UCI Medical Center
Orange, California, 92868
About this study
Official title: Optical Coherence Tomography for Early Detection and Staging of Endobronchial Lung and Pleural Cancer, Airway Injury, and Prostate Cancer
This study has been designed to utilize already obtained biopsy specimens for investigation of the utility of a new, non-invasive optical diagnostic technique. The study will allow a careful correlation between the Optical coherence tomography findings and conventional histology.
Read the detailed description
Optical coherence tomography is a non-invasive diagnostic technique that can provide information about tissue abnormalities, change in structure of an organ. This technique uses a near-infrared diode to emit light that can produce images of the specimen under investigation without causing damage or alterations.
- Conditions
- Lung Cancer, Pleural Cancer, Prostate Cancer
- Being tested
- diagnostic
- Keywords
- early detection of lung and pleural cancer, early detection of prostate cancer
- Medical subject headings
- Lung Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosticDevice
oct imaging
| Study group | Role | What they receive |
|---|---|---|
| diagnostic | oct imaging Receives: Device: diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathology results.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startMar 2007
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: Not NIH defined clinical trial
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 University of California, IrvineThe 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Matthew Brenner, M.D, Principal investigator, Beckman Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581503
- Sponsor's protocol ID
- 20064981
- Status last verified
- Oct 2022
- First submitted
- 19 Dec 2007
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography for Early Detection and Staging of Endobronchial Lung and Pleural Cancer, Airway Injury, and Prostate Cancer
- ClinicalTrials.gov ID
- NCT00581503
- Acronym / sponsor ID
- 20064981
- Conditions
- Lung Cancer, Pleural Cancer, Prostate Cancer
- Keywords
- early detection of lung and pleural cancer, early detection of prostate cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not NIH defined clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Mar 2007
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 27 Dec 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.
This study has been designed to utilize already obtained biopsy specimens for investigation of the utility of a new, non-invasive optical diagnostic technique. The study will allow a careful correlation between the Optical coherence tomography findings and conventional histology.
Detailed description
Optical coherence tomography is a non-invasive diagnostic technique that can provide information about tissue abnormalities, change in structure of an organ. This technique uses a near-infrared diode to emit light that can produce images of the specimen under investigation without causing damage or alterations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnostic | – | Device: diagnosticoct imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population will be identified at UCIMC, who is scheduled for prostatectomy, endobronchial, transbronchial, and pleural biopsy will be recurited to participate in the study.
Key inclusion criteria (2 listed)
- Adult 18 years and older
- Having procedure of endobronchial, transbronchial, and / or pleural biopsy
Key exclusion criteria (2 listed)
- Currently participating in any other investigational drug or device evaluation.
- Currently taking drugs that are sensitive to light.
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 |
|---|---|---|
| diagnosticoct imaging | Device | diagnostic |
Primary outcome
Pathology results.
Time frame: 30 minutes
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 20 Oct 2022.
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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.
Matthew Brenner, M.D principal investigator
Beckman Laser Institute
2 sites 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 Pleural Cancer, run by University of California, Irvine at 2 sites 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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Pathology results. (time frame: 30 minutes). 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 20 Oct 2022.