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| Sponsored by: |
Royal Marsden - London |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005071 |
Purpose
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.
| Condition | Intervention |
|
Cancer-Related Problem/Condition Lung Cancer |
Procedure: biopsy Procedure: bronchoscopy Procedure: computed tomography |
| MedlinePlus related topics: | Cancer Lung Cancer |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized |
| 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) |
| Study Start Date: | October 1998 |
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 (e.g., 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.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Possible diagnosis of lung cancer Fit enough for bronchoscopy and CT scan
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: Not specified
Contacts and Locations
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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| Study ID Numbers: | CDR0000067676, RMNHS-PATHWAY, EU-99039 |
| First Received: | April 6, 2000 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005071 |
| Health Authority: | United States: Federal Government |
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