Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012103
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
2001-03-03
Brief Title:
Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Prevention and Early Detection of Lung Cancer in Women
Status:
COMPLETED
Status Verified Date:
2011-03
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:
None
Brief Summary:
RATIONALE Imaging procedures such as computed tomography may improve the ability to detect lung cancer earlier
PURPOSE Screening and diagnostic study of computed tomography in women who are at risk for lung cancer
PURPOSE Screening and diagnostic study of computed tomography in women who are at risk for lung cancer
Detailed Description:
OBJECTIVES
Determine the ability of computed tomography CT to detect early lung parenchymal abnormalities in women at high risk for lung cancer
Determine the number of abnormal findings detected by CT that develop into lung cancer in these patients
Correlate these abnormalities with the presence of K-ras and p53 mutations in the sputum and bronchoalveolar lavage in these patients
Develop and implement appropriate educational materials regarding lung cancer in women and provide referrals to other programs such as smoking cessation programs
OUTLINE Patients complete a questionnaire at baseline to assess demographics medical history smoking history menopausal status estrogen therapy and diet
Patients then undergo a low-dose computed tomography CT scan without contrast Patients with normal CT results undergo additional CT scans every 12 months
Patients with abnormal CT results undergo a diagnostic CT scan in the absence of prior studies Patients with indeterminate nodules less than 5 mm in size undergo surveillance CT studies within 3-4 months If nodules remain unchanged in size patients undergo additional surveillance CT studies at 6 months and 1 year Patients with lung parenchymal abnormalities on CT suspicious for malignancy undergo a bronchoscopy with biopsy and bronchoalveolar lavage BAL Patients with abnormal CT scans and negative BAL for p53 andor K-ras mutations or normal histology and positive BAL for K-ras andor p53 mutations undergo additional CT scans at 6 months and 1 year Patients with biopsy-proven malignancy after bronchoscopy are referred for definitive treatment
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study
Determine the ability of computed tomography CT to detect early lung parenchymal abnormalities in women at high risk for lung cancer
Determine the number of abnormal findings detected by CT that develop into lung cancer in these patients
Correlate these abnormalities with the presence of K-ras and p53 mutations in the sputum and bronchoalveolar lavage in these patients
Develop and implement appropriate educational materials regarding lung cancer in women and provide referrals to other programs such as smoking cessation programs
OUTLINE Patients complete a questionnaire at baseline to assess demographics medical history smoking history menopausal status estrogen therapy and diet
Patients then undergo a low-dose computed tomography CT scan without contrast Patients with normal CT results undergo additional CT scans every 12 months
Patients with abnormal CT results undergo a diagnostic CT scan in the absence of prior studies Patients with indeterminate nodules less than 5 mm in size undergo surveillance CT studies within 3-4 months If nodules remain unchanged in size patients undergo additional surveillance CT studies at 6 months and 1 year Patients with lung parenchymal abnormalities on CT suspicious for malignancy undergo a bronchoscopy with biopsy and bronchoalveolar lavage BAL Patients with abnormal CT scans and negative BAL for p53 andor K-ras mutations or normal histology and positive BAL for K-ras andor p53 mutations undergo additional CT scans at 6 months and 1 year Patients with biopsy-proven malignancy after bronchoscopy are referred for definitive treatment
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA016087 | NIH | None | None |
| NYU-9928 | None | None | None |
| NCI-G01-1913 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |