Lung CancerNCT00205439
Surveillance For New Lung Primaries
An observational study of Lung Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The primary goal of this study is to determine the prevalence of tracheobronchial carcinomas in patients with a history of squamous cell cancer of the aerodigestive tract who have been treated with a curative intent and remain disease free. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Dec 2005
- 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: Patients with new lung primaries after curative therapy for squamous cell carcinoma of the aerodigestive tract
Who may be able to join
- History squamous cell NSCLC who have undergone complete resection or definitive chemotherapy
Who cannot join
- History of an aerodigestive tract carcinoma of non-squamous histology
- Patients who have Stage IIIA, IIIB or IV squamous cell lung cancer that have undergone resection or chemotherapy within three years
- Patients who have Stage I or II squamous cell lung cancer that have undergone resection or chemotherapy within one year
- Patients who have received external beam radiation therapy for treatment of a squamous cell cancer of the lung
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: Fluorescence Bronchoscopic Surveillance For New Lung Primaries After Curative Therapy for Squamous Cell Carcinoma of the Aerodigestive Tract"
The primary goal of this study is to determine the prevalence of tracheobronchial carcinomas in patients with a history of squamous cell cancer of the aerodigestive tract who have been treated with a curative intent and remain disease free. Detection of pre-invasive and invasive lesions (moderate to severe dysplasia, CIS) with fluorescence bronchoscopic surveillance may help to define the natural history of these lesions and allow earlier intervention should they progress to invasive lesions.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung 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 |
|---|---|---|
| Fluorescence bronchosopy with sputum cytology | Patients undergo surgery with Fluorescence bronchosopy and sputum cytology. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2001
- Primary completionDec 2005
- Study completionDec 2005
Why it stopped: low accrual
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.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tracey Weigel, MD, Principal investigator, University of Wisconsin Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205439
- Sponsor's protocol ID
- CC01506
- Other IDs
- 2001-431
- Status last verified
- Jul 2015
- First submitted
- 13 Sep 2005
- Last updated
- 15 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence Bronchoscopic Surveillance For New Lung Primaries After Curative Therapy for Squamous Cell Carcinoma of the Aerodigestive Tract"
- ClinicalTrials.gov ID
- NCT00205439
- Acronym / sponsor ID
- CC01506
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Dec 2001
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 20 Sep 2005 (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.
The primary goal of this study is to determine the prevalence of tracheobronchial carcinomas in patients with a history of squamous cell cancer of the aerodigestive tract who have been treated with a curative intent and remain disease free. Detection of pre-invasive and invasive lesions (moderate to severe dysplasia, CIS) with fluorescence bronchoscopic surveillance may help to define the natural history of these lesions and allow earlier intervention should they progress to invasive lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorescence bronchosopy with sputum cytology | – | –Patients undergo surgery with Fluorescence bronchosopy and sputum cytology. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with new lung primaries after curative therapy for squamous cell carcinoma of the aerodigestive tract
Key inclusion criteria (1 listed)
- History squamous cell NSCLC who have undergone complete resection or definitive chemotherapy
Key exclusion criteria (4 listed)
- History of an aerodigestive tract carcinoma of non-squamous histology
- Patients who have Stage IIIA, IIIB or IV squamous cell lung cancer that have undergone resection or chemotherapy within three years
- Patients who have Stage I or II squamous cell lung cancer that have undergone resection or chemotherapy within one year
- Patients who have received external beam radiation therapy for treatment of a squamous cell cancer of the lung
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- University of Wisconsin Carbone Cancer CenterLink 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.
Tracey Weigel, MD principal investigator
University of Wisconsin Medical School
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, run by University of Wisconsin, Madison 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 1 inclusion and 4 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 15 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 was stopped early (reason given: low accrual). 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.
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 15 Nov 2019; AzTrials last refreshed its copy on 31 Oct 2026.