Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005071
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2000-04-06
Brief Title:
Diagnosis and Treatment Planning in Patients Suspected of Having Lung Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study Leading to a Randomized Trial Comparing Outcomes in Patients With Suspected Lung Cancer Investigated in the Conventional Locally LO Based BA Chest Clinic Compared With a Centralized 2 Stop Pathway LOBA 2STOP
Status:
UNKNOWN
Status Verified Date:
2007-06
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 and treatment-planning systems may affect outcome in patients suspected of having lung cancer
PURPOSE Randomized diagnostic trial to compare the effectiveness of two types of diagnostic and treatment-planning systems in patients who are suspected of having lung cancer
PURPOSE Randomized diagnostic trial to compare the effectiveness of two types of diagnostic and treatment-planning systems in patients who are suspected of having lung cancer
Detailed Description:
OBJECTIVES I Compare the survival rate of patients with suspected lung cancer when diagnosed and managed using the conventional locally based approach versus a new centralized system using a 2 stop diagnosis II Compare the resection rate in both diagnostic arms III Assess the quality of service given in both diagnostic arms
OUTLINE This is a randomized study Patients present to a general practitioner where they are referred to the local chest clinic Patients are seen by the chest physician and if deemed eligible are randomized between 2 diagnostic arms Arm I Conventional Locally Based Diagnosis Patients undergo bronchoscopy and CT scan as appropriate and then are discussed or referred by individual chest physicians as is the current practice The optimal period for diagnosis and discussion of management plans is 6 weeks Arm II Centralized 2 Stop Diagnosis Patients undergo CT scan the following Monday morning The consultant radiologist advises the most appropriate diagnostic test eg bronchoscopy or percutaneous needle biopsy to be done that same Monday A tissue diagnosis is available Thursday morning for the multidisciplinary meeting attended by the chest physician medical and clinical oncologists and a surgeon and the patient treatment plan is decided Quality of life is assessed at baseline and at 6 weeks Patients are followed for 2 years
PROJECTED ACCRUAL A total of 252-315 patients will be accrued for this study within 2 years
OUTLINE This is a randomized study Patients present to a general practitioner where they are referred to the local chest clinic Patients are seen by the chest physician and if deemed eligible are randomized between 2 diagnostic arms Arm I Conventional Locally Based Diagnosis Patients undergo bronchoscopy and CT scan as appropriate and then are discussed or referred by individual chest physicians as is the current practice The optimal period for diagnosis and discussion of management plans is 6 weeks Arm II Centralized 2 Stop Diagnosis Patients undergo CT scan the following Monday morning The consultant radiologist advises the most appropriate diagnostic test eg bronchoscopy or percutaneous needle biopsy to be done that same Monday A tissue diagnosis is available Thursday morning for the multidisciplinary meeting attended by the chest physician medical and clinical oncologists and a surgeon and the patient treatment plan is decided Quality of life is assessed at baseline and at 6 weeks Patients are followed for 2 years
PROJECTED ACCRUAL A total of 252-315 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| EU-99039 | None | None | None |
| RMNHS-PATHWAY | None | None | None |