Diagnosis and Treatment Planning in Patients Suspected of Having Lung Cancer
NCT ID: NCT00005071
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
INTERVENTIONAL
1998-10-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
DIAGNOSTIC
Interventions
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biopsy
bronchoscopy
computed tomography
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
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
ALL
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Principal Investigators
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Mary O'Brien, MD
Role: STUDY_CHAIR
Royal Marsden NHS Foundation Trust
Locations
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Royal Marsden Hospital
Sutton, England, United Kingdom
Countries
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Other Identifiers
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RMNHS-PATHWAY
Identifier Type: -
Identifier Source: secondary_id
EU-99039
Identifier Type: -
Identifier Source: secondary_id
CDR0000067676
Identifier Type: -
Identifier Source: org_study_id