Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002667
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Early Detection of Second Lung Cancer in Patients With Stage I Non-small Cell Lung Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
EARLY DETECTION OF SECOND PRIMARY LUNG CANCERS BY SPUTUM CYTOLOGY IMMUNOSTAINING
Status:
COMPLETED
Status Verified Date:
2023-06
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 Using new methods to examine sputum samples for the presence of cancer cells may detect lung cancer earlier
PURPOSE Screening trial to study the effectiveness of new methods of examining sputum samples to detect second primary lung cancer in patients with resected stage I non-small cell lung cancer
PURPOSE Screening trial to study the effectiveness of new methods of examining sputum samples to detect second primary lung cancer in patients with resected stage I non-small cell lung cancer
Detailed Description:
OBJECTIVES I Evaluate whether immunostaining of induced sputum specimens improves the sensitivity and specificity of routine morphologic sputum surveillance to detect second primary lung cancer in patients with previously resected nonsmall cell lung cancer II Evaluate which patients are at risk of developing a second primary lung cancer by immunostaining specimens from patients with no morphologic atypia on routine Papanicolaou cytology III Make available archived sputum samples and bronchial washings for further analysis of new antibodies and techniques IV Evaluate whether analysis of elevations of relevant growth factors in bronchial lavage fluid from patients with positive immunostaining or morphologic atypia increases the accuracy of early detection V Evaluate whether quantitation of shed antigens in sputum increases the accuracy of early detection VI Evaluate whether the extent of airway obstruction as measured by the forced expiratory volume can predict an increased risk of developing lung cancer
OUTLINE Screening for Second Primary Lung Cancer Annual sputum induction for Papanicolaou cytology and immunostaining using monoclonal antibodies 624H12 and 703D4 with optional pulmonary function tests and fiberoptic bronchoscopy with bronchial washings
PROJECTED ACCRUAL 1100 patients will be entered over 3 years The sample size will be adjusted based on the rate of positive staining in the first 100 patients Patients followed at uncertified centers are analyzed separately
OUTLINE Screening for Second Primary Lung Cancer Annual sputum induction for Papanicolaou cytology and immunostaining using monoclonal antibodies 624H12 and 703D4 with optional pulmonary function tests and fiberoptic bronchoscopy with bronchial washings
PROJECTED ACCRUAL 1100 patients will be entered over 3 years The sample size will be adjusted based on the rate of positive staining in the first 100 patients Patients followed at uncertified centers are analyzed separately
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-P95-0067 | None | None | None |
| E-5593 | None | None | None |
| SWOG-9437 | None | None | None |
| JHOC-9152 | None | None | None |