Fast-track Diagnosis for Lung Cancer Suspects With PET-CT and EUS
Patients who are admitted to the outpatient pulmonology department by a general practitioner or specialist with a chest X-ray suspicious for lung cancer with an age between 18 and 80 years are suitable for participation. The X-ray and referral are studied by a chest physician (by phone or fax ). Selected patients are invited to enter the study after answering a questionnaire by phone (p. 31). The questionnaire screens patients' interest, co-morbidity and medication use. Informed consent forms, patient information forms and a time table for the diagnostic day are provided by mail or E-mail in cases where time gets short. Waiting time to enter the study will be no longer than one week.
Hundred patients will be recruited by means of informed consent. Patients will be admitted at the pulmonary ward for the study day and will be accompanied by nurses. All patients will get PET-CT scanning in the morning of the study day. Depending on the location of lesions seen on PET-CT, further invasive diagnostic procedures will be planned for the afternoon.
Mediastinal and adjacent structures will be analysed with EUS-FNA. Mediastinal staging will be done with bronchoscopy alone for central located tumors, peripherally located lesions will be analysed with EUS-FNA or bronchoscopy.
The percentage of patients in which this diagnostic track leads to a diagnosis and tumor stage in one day will be determined. The number of tests and diagnostic procedures needed to obtain a diagnosis, including tumor stage (especially final stage NSCLC) and function tests, will be compared with a historical matched study group. This historical study group is chosen from an era before the availability of integrated PET-CT and ultrasound guided endoscopic tools and meets the same inclusion and exclusion criteria as the patients in this study. The timelines from initial chest X-ray to diagnostic day to informing the patient to start of treatment will be determined. These figures will be compared with the historical study group.
Procedure: fast track diagnosis
Procedure: conventional diagnosis
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective, Open, Single Center, Study of One-day Diagnostic Track for Lung Cancer Suspects From Chest X-ray Using PET-CT and Subsequent Multiple Endoscopic Investigations. (Including Bronchoscopy, EUS-FNA)|
- Number of patients that will have a definitive diagnosis and final stage NSCLC in one day [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Number of tests and procedures that have been performed. Patient satisfaction with the one-day procedure. Sensitivity of EUS-FNA and EBUS-TBNA when immunohistochemical analysis is added to investigate false negative procedures. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Procedure: fast track diagnosis
fast-track diagnosis, PET-CT, bronchoscopyProcedure: conventional diagnosis
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00556647
|Zwolle, Netherlands, 8011 JW|
|Study Director:||J. Stigt, Drs.||Isala|