Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006087
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2000-08-03
Brief Title:
Chest X-Ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer
Sponsor:
Jewish Hospital and St Marys Healthcare
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 high-risk of developing 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 1000 patients 500 per screening arm will be accrued for this study
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 1000 patients 500 per screening arm will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V00-1600 | None | None | None |
| JHL-45199 | None | None | None |