Lung CancerPhase 2NCT00103363
Sputum Cytology in Screening Heavy Smokers For Lung Cancer
A Phase 2 study testing cytology specimen collection procedure, physiologic testing and annual screening in people with Lung Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
RATIONALE: Screening tests, such as sputum cytology, may help doctors find tumor cells early and plan better treatment for lung cancer. PURPOSE: This phase II trial is studying how well sputum cytology works in screening heavy smokers for lung cancer. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- cytology specimen collection procedure, physiologic testing and annual screening
- Type of treatment
- Surgery or procedure
- How many people
- 3,270 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1993to Feb 1994
- Phase
- Phase 2
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Current or ex-smoker with a lifetime history of cigarette smoking of ≥ 20 pack years, meeting 1 of the following criteria:
- Airflow obstruction
- FEV_1 < 75% predicted for age by spirometry
- FEV_1/FVC ≤ 75% by spirometry
- No airflow obstruction
- No history of lung cancer
PATIENT CHARACTERISTICS:
Age
- 25 and over
Performance status
- Not specified
Life expectancy
- More than 5 years
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No cancer within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Health Sciences Center - Denver
Denver, Colorado, 80262
About this study
Official title: Lung Cancer Screening and Tissue Procurement
RATIONALE: Screening tests, such as sputum cytology, may help doctors find tumor cells early and plan better treatment for lung cancer.
PURPOSE: This phase II trial is studying how well sputum cytology works in screening heavy smokers for lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Classify annual sputum samples cytologically in participants with or without airflow obstruction and a heavy smoking history.
- Correlate sputum cytological atypia (moderate atypia or worse) with lung cancer incidence in these participants.
- Correlate changes in sputum cytology (i.e., changes toward higher grades of atypia) with lung cancer incidence in these participants.
Secondary
- Determine other risk factors for lung cancer (e.g., diet, family history, smoking history, and medications) that may either confound or modify the association between sputum cytology and lung cancer risk in these participants.
OUTLINE: Two 3-day pooled sputum samples are collected for 6 consecutive days from participants by the spontaneous cough technique for cytopathological evaluation. Participants also complete a risk factor questionnaire and undergo a pulmonary function test by spirometry and a blood draw.
Participants complete a questionnaire updating smoking, vital, and lung cancer status and undergo sputum sample collection annually.
Participants are informed of sputum cytology results.
PROJECTED ACCRUAL: A total of 3,400 participants (2,900 with airflow obstruction and 500 without airflow obstruction) will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- cytology specimen collection procedure, physiologic testing, annual screening, study of high risk factors
- Keywords
- non-small cell lung cancer, small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytology specimen collection procedureOther
physiologic testingOther
annual screeningProcedure or surgery
study of high risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of annual sputum samples cytologically
Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence
Correlation of changes in sputum cytology with lung cancer incidence
Secondary outcomes (1)
Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2005 (estimated)
- Study startFeb 1993
- Primary completionFeb 1994
- Study completionFeb 1994
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 Colorado, DenverThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Enrolment
- 3,270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Timothy Kennedy, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103363
- Sponsor's protocol ID
- 92-0392
- Other IDs
- UCHSC-92-392
- Status last verified
- May 2014
- First submitted
- 7 Feb 2005
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Screening and Tissue Procurement
- ClinicalTrials.gov ID
- NCT00103363
- Acronym / sponsor ID
- 92-0392
- Conditions
- Lung Cancer
- Keywords
- non-small cell lung cancer, small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,270 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 1993
- Primary completion
- Feb 1994 (actual)
- Study completion
- Feb 1994 (actual)
- First posted
- 8 Feb 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.
RATIONALE: Screening tests, such as sputum cytology, may help doctors find tumor cells early and plan better treatment for lung cancer.
PURPOSE: This phase II trial is studying how well sputum cytology works in screening heavy smokers for lung cancer.
Detailed description
OBJECTIVES:
Primary
- Classify annual sputum samples cytologically in participants with or without airflow obstruction and a heavy smoking history.
- Correlate sputum cytological atypia (moderate atypia or worse) with lung cancer incidence in these participants.
- Correlate changes in sputum cytology (i.e., changes toward higher grades of atypia) with lung cancer incidence in these participants.
Secondary
- Determine other risk factors for lung cancer (e.g., diet, family history, smoking history, and medications) that may either confound or modify the association between sputum cytology and lung cancer risk in these participants.
OUTLINE: Two 3-day pooled sputum samples are collected for 6 consecutive days from participants by the spontaneous cough technique for cytopathological evaluation. Participants also complete a risk factor questionnaire and undergo a pulmonary function test by spirometry and a blood draw.
Participants complete a questionnaire updating smoking, vital, and lung cancer status and undergo sputum sample collection annually.
Participants are informed of sputum cytology results.
PROJECTED ACCRUAL: A total of 3,400 participants (2,900 with airflow obstruction and 500 without airflow obstruction) will be accrued for this study.
Study design
- Primary purpose
- Screening
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cytology specimen collection procedure | Other | – |
| physiologic testing | Other | – |
| annual screening | Procedure or surgery | – |
| study of high risk factors | Procedure or surgery | – |
Primary outcome
Classification of annual sputum samples cytologically
Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence
Correlation of changes in sputum cytology with lung cancer incidence
1 secondary outcome
Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk
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 7 May 2014.
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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.
Timothy Kennedy principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cytology specimen collection procedure, physiologic testing and annual screening in people with Lung Cancer, run by University of Colorado, Denver 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?
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 7 May 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Classification of annual sputum samples cytologically. The study lists 3 primary outcomes in all. 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 7 May 2014.