Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047385
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2002-10-03
Brief Title:
National Lung Screening Trial NLST Screening
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
National Lung Screening Trial A Randomized Trial Comparing Low-dose Helical CT With Chest Xray for Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
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:
NLST
Brief Summary:
RATIONALE Effective screening tests should help doctors detect lung cancer early and plan curative treatment It is not yet known whether low-dose helical computed tomography LDCT screening is more effective than chest radiography CXR screening in reducing death from lung cancer
PURPOSE Randomized clinical trial to compare the effectiveness of LDCT scan with that of CXR in screening individuals who are at high risk for developing lung cancer
PURPOSE Randomized clinical trial to compare the effectiveness of LDCT scan with that of CXR in screening individuals who are at high risk for developing lung cancer
Detailed Description:
OBJECTIVES
Compare whether screening with low-dose helical CT scan vs chest x-ray reduces lung cancer-specific mortality in participants who are at high risk for developing lung cancer
OUTLINE
NLST participants were randomized to either low-dose helical CT or chest x-ray in equal proportions A total of 53454 participants were enrolled 26722 in low-dose CT and 26732 in chest radiography at 33 screening centers across the United States Screening was offered three times at baseline and two annual follow-up examinations The primary endpoint of the study was lung cancer mortality The study arms were compared with regard to overall mortality lung cancer incidence and screening-related complications
All low-dose scanners and chest x-ray machines were certified for use and met NLST protocol requirements and American College of Radiology guidelines Low-dose CT acquisitions and chest radiographs were interpreted by trained radiologists Participants and their health care provider were informed of study examination results Participants with abnormalities suspicious for lung cancer were contacted for information regarding diagnostic evaluation Medical records were collected on diagnostic evaluation medical complications and initial treatment
Participants were then contacted at least annually by mail or telephone
The National Lung Screening Trial NLST represents the union of two NCI-sponsored efforts the NCI Lung Screening Study and the American College of Radiology Imaging Network ACRIN
Compare whether screening with low-dose helical CT scan vs chest x-ray reduces lung cancer-specific mortality in participants who are at high risk for developing lung cancer
OUTLINE
NLST participants were randomized to either low-dose helical CT or chest x-ray in equal proportions A total of 53454 participants were enrolled 26722 in low-dose CT and 26732 in chest radiography at 33 screening centers across the United States Screening was offered three times at baseline and two annual follow-up examinations The primary endpoint of the study was lung cancer mortality The study arms were compared with regard to overall mortality lung cancer incidence and screening-related complications
All low-dose scanners and chest x-ray machines were certified for use and met NLST protocol requirements and American College of Radiology guidelines Low-dose CT acquisitions and chest radiographs were interpreted by trained radiologists Participants and their health care provider were informed of study examination results Participants with abnormalities suspicious for lung cancer were contacted for information regarding diagnostic evaluation Medical records were collected on diagnostic evaluation medical complications and initial treatment
Participants were then contacted at least annually by mail or telephone
The National Lung Screening Trial NLST represents the union of two NCI-sponsored efforts the NCI Lung Screening Study and the American College of Radiology Imaging Network ACRIN
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 |
|---|---|---|---|
| CDR0000257938 | REGISTRY | PDQ Physician Database Query | httpsreporternihgovquickSearchN1CN25476A-85-0-1 |
| U01CA079778 | NIH | None | None |
| U01CA080098 | NIH | None | None |
| N1CN25476A-85-0-1 | NIH | None | None |
| NIHNCI | OTHER | None | None |