Lung CancerNCT00006087
Chest X-Ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer
A study testing annual screening, bronchoscopic and lung imaging studies and comparison of screening methods in people with Lung Cancer, run by Jewish Hospital and St. Mary's Healthcare at 1 site in United States.
Trial summary
RATIONALE: Diagnostic procedures such as chest x-ray and chest CT scans may be effective in early detection of lung cancer. PURPOSE: Randomized clinical trial to compare the effectiveness of a chest CT scan given once a year with that of a chest x-ray given once a year in detecting lung cancer in patients at a… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- annual screening, bronchoscopic and lung imaging studies and comparison of screening methods
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 1999to not given
- Phase
- Interventional
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Patients at high risk for the development of lung cancer as defined by the following: At least 40 pack years smoking (may have stopped smoking within past 10 years) at time of study entry FEV-1/FVC ratio less than 70% predicted OR FEV-1 less than 80% predicted obtained from 3 serial performances with less than 5% difference Normal or stable current chest x-ray
PATIENT CHARACTERISTICS: Age: 40 to 70 Performance status: Not specified Life expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: See Disease Characteristics Other: No other comorbidity that limits life span to less than 5 years No prior cancer except nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant Negative pregnancy test Fertile patients must use effective contraception
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.
About this study
Official title: A Randomized Prospective Study Comparing Annual Chest X-Rays to Annual Spiral Chest CT Scanning in Patients at High-Risk for the Development of Lung Cancer
RATIONALE: Diagnostic procedures such as chest x-ray and chest CT scans may be effective in early detection of lung cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of a chest CT scan given once a year with that of a chest x-ray given once a year in detecting lung cancer in patients at a high-risk of developing lung cancer.
Read the detailed description
OBJECTIVES: I. Determine the efficacy of a lung cancer risk assessment questionnaire combined with spirometry testing in identifying a statistically significant number of persons with high-risk behaviors for the development of lung cancer. II. Determine the sensitivity of these screening techniques in identifying a population at high risk for the development of lung cancer. III. Determine the number of patients necessary to screen in order to identify the high-risk population eligible for this study. IV. Determine the lead time bias of CT scans versus chest x-rays in these patients. V. Determine the efficacy of spiral CT scanning of the chest in detecting early lung cancers not visible on chest x-rays in patients at high risk for lung cancer. VI. Compare annual spiral CT scanning versus annual chest x-rays in detecting lung cancer in these patients. VII. Compare survival and fatality in these patients with these detection methods.
OUTLINE: Patients are randomized to one of two screening arms. Arm I: Patients receive routine medical care, an annual nursing assessment, and an annual chest x-ray. Any new abnormality identified is further evaluated through standard acceptable medical interventions. Arm II: Patients receive routine medical care, an annual nursing assessment, and an annual spiral CT scan of the chest. If an abnormal mass greater than 10 mm in diameter or 5-10 mm in diameter and highly suspicious for malignancy is detected, chest x-ray and tissue diagnosis is obtained. If the abnormal mass is 10 mm or less in diameter, a thin section high resolution image of the mass is obtained. If this image is normal or benign, annual spiral CT scanning is continued. If the image is indeterminate, a repeat high resolution scan is performed in 3 months. If the image is unchanged at 3 months, annual spiral CT scanning is continued. If the mass is larger at 3 months, chest x-ray and tissue diagnosis is performed. Screening continues for 5 years in the absence of disease detection.
PROJECTED ACCRUAL: A minimum of 1,000 patients (500 per screening arm) will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- annual screening, bronchoscopic and lung imaging studies, comparison of screening methods, computed tomography, radiography
- 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.
annual screeningProcedure or surgery
bronchoscopic and lung imaging studiesProcedure or surgery
comparison of screening methodsProcedure or surgery
computed tomographyProcedure or surgery
radiographyProcedure or surgery
study of high risk factorsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2003 (estimated)
- Study startNov 1999
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
Sponsor and investigators
- Lead sponsor
- Jewish Hospital and St. Mary's Healthcare
- Sponsor type
- University, hospital or other
- Investigators
- Renato V. LaRocca, MD, FACP, Study chair, Kentuckiana Cancer Institute, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006087
- Sponsor's protocol ID
- CDR0000068079
- Other IDs
- JHL-45199, NCI-V00-1600
- Status last verified
- Dec 2007
- First submitted
- 3 Aug 2000
- Last updated
- 9 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Study Comparing Annual Chest X-Rays to Annual Spiral Chest CT Scanning in Patients at High-Risk for the Development of Lung Cancer
- ClinicalTrials.gov ID
- NCT00006087
- Acronym / sponsor ID
- CDR0000068079
- Conditions
- Lung Cancer
- Keywords
- non-small cell lung cancer, small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Jewish Hospital and St. Mary's HealthcareUniversity, hospital or other
- Study start
- Nov 1999
- First posted
- 23 Dec 2003 (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 chest x-ray and chest CT scans may be effective in early detection of lung cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of a chest CT scan given once a year with that of a chest x-ray given once a year in detecting lung cancer in patients at a high-risk of developing lung cancer.
Detailed description
OBJECTIVES: I. Determine the efficacy of a lung cancer risk assessment questionnaire combined with spirometry testing in identifying a statistically significant number of persons with high-risk behaviors for the development of lung cancer. II. Determine the sensitivity of these screening techniques in identifying a population at high risk for the development of lung cancer. III. Determine the number of patients necessary to screen in order to identify the high-risk population eligible for this study. IV. Determine the lead time bias of CT scans versus chest x-rays in these patients. V. Determine the efficacy of spiral CT scanning of the chest in detecting early lung cancers not visible on chest x-rays in patients at high risk for lung cancer. VI. Compare annual spiral CT scanning versus annual chest x-rays in detecting lung cancer in these patients. VII. Compare survival and fatality in these patients with these detection methods.
OUTLINE: Patients are randomized to one of two screening arms. Arm I: Patients receive routine medical care, an annual nursing assessment, and an annual chest x-ray. Any new abnormality identified is further evaluated through standard acceptable medical interventions. Arm II: Patients receive routine medical care, an annual nursing assessment, and an annual spiral CT scan of the chest. If an abnormal mass greater than 10 mm in diameter or 5-10 mm in diameter and highly suspicious for malignancy is detected, chest x-ray and tissue diagnosis is obtained. If the abnormal mass is 10 mm or less in diameter, a thin section high resolution image of the mass is obtained. If this image is normal or benign, annual spiral CT scanning is continued. If the image is indeterminate, a repeat high resolution scan is performed in 3 months. If the image is unchanged at 3 months, annual spiral CT scanning is continued. If the mass is larger at 3 months, chest x-ray and tissue diagnosis is performed. Screening continues for 5 years in the absence of disease detection.
PROJECTED ACCRUAL: A minimum of 1,000 patients (500 per screening arm) will be accrued for this study.
Study design
- Primary purpose
- Screening
Who may qualify
- Ages
- 40 to 70 years
- 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 |
|---|---|---|
| annual screening | Procedure or surgery | – |
| bronchoscopic and lung imaging studies | Procedure or surgery | – |
| comparison of screening methods | Procedure or surgery | – |
| computed tomography | Procedure or surgery | – |
| radiography | Procedure or surgery | – |
| study of high risk factors | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
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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.
Renato V. LaRocca, MD, FACP study chair
Kentuckiana Cancer Institute, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing annual screening, bronchoscopic and lung imaging studies and comparison of screening methods in people with Lung Cancer, run by Jewish Hospital and St. Mary's Healthcare 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: status not confirmed, as of the sponsor's last update on 9 Feb 2009. 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?
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 9 Feb 2009.