Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003006
Status:
COMPLETED
Last Update Posted:
2016-06-29
First Post:
1999-11-01
Brief Title:
Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Detection of Occult Micrometastases in Patients With Clinical Stage I NSCLC A Prospective Analysis
Status:
COMPLETED
Status Verified Date:
2016-06
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 Detecting very early metastases in bone marrow andor lymph nodes may help doctors plan better treatment for non-small cell lung cancer
PURPOSE Clinical trial to detect the presence of metastatic cancer in patients with stage I non-small cell lung cancer that has not been previously treated
PURPOSE Clinical trial to detect the presence of metastatic cancer in patients with stage I non-small cell lung cancer that has not been previously treated
Detailed Description:
OBJECTIVES
Determine whether the presence of occult micrometastases OM detected by immunohistochemistry or reverse transcriptase-polymerase chain reaction RT-PCR in histologically negative lymph nodes or bone marrow is associated with poorer survival among patients with stage I non-small cell lung cancer
Determine the incidence of OM in histologically negative lymph nodes and bone marrow by immunohistochemistry staining for cytokeratins and the CEA glycoprotein or RT-PCR to detect CEA mRNA in these patients
Assess the sensitivity of immunohistochemistry relative to RT-PCR for detecting OM in these patients
Determine the relationship between tumor size or T-stage and the presence of OM detected by immunohistochemistry or RT-PCR in these patients
Determine the relationship between the presence of OM and disease-free survival in these patients
Determine the relationship between the site of OM and incidence of recurrence site of recurrence and survival of these patients
OUTLINE At the time of thoracotomy and pulmonary resection patients have samples of bone marrow primary tumor and intrathoracic lymph nodes harvested The presence of occult metastases in bone marrow and lymph nodes is assessed using immunohistochemistry or reverse transcriptase-polymerase chain reaction
Patients are followed every 6 months for 5 years
Determine whether the presence of occult micrometastases OM detected by immunohistochemistry or reverse transcriptase-polymerase chain reaction RT-PCR in histologically negative lymph nodes or bone marrow is associated with poorer survival among patients with stage I non-small cell lung cancer
Determine the incidence of OM in histologically negative lymph nodes and bone marrow by immunohistochemistry staining for cytokeratins and the CEA glycoprotein or RT-PCR to detect CEA mRNA in these patients
Assess the sensitivity of immunohistochemistry relative to RT-PCR for detecting OM in these patients
Determine the relationship between tumor size or T-stage and the presence of OM detected by immunohistochemistry or RT-PCR in these patients
Determine the relationship between the presence of OM and disease-free survival in these patients
Determine the relationship between the site of OM and incidence of recurrence site of recurrence and survival of these patients
OUTLINE At the time of thoracotomy and pulmonary resection patients have samples of bone marrow primary tumor and intrathoracic lymph nodes harvested The presence of occult metastases in bone marrow and lymph nodes is assessed using immunohistochemistry or reverse transcriptase-polymerase chain reaction
Patients are followed every 6 months for 5 years
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 |
|---|---|---|---|
| CDR0000065576 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-9761 | None | None | None |