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| Sponsor: | Isala Klinieken |
|---|---|
| Information provided by: | Isala Klinieken |
| ClinicalTrials.gov Identifier: | NCT00556647 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Procedure: fast track diagnosis Procedure: conventional diagnosis |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| 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) |
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | September 2008 |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Fast-track diagnosis
|
Procedure: fast track diagnosis
fast-track diagnosis, PET-CT, bronchoscopy
|
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B: Active Comparator
Conventional diagnosis
|
Procedure: conventional diagnosis
out-patient diagnosis
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: J. Stigt, MD | +31 38 4242000 ext 7002 | j.a.stigt@isala.nl |
| Netherlands | |
| Isala Klinieken | Recruiting |
| Zwolle, Netherlands, 8011 JW | |
| Contact: J.A. Stigt, Drs. 038-4242000 ext 7002 | |
| Principal Investigator: L.N. Boom | |
| Study Director: | J. Stigt, Drs. | Isala Klinieken |
More Information
| Study ID Numbers: | NL12541.075.06 |
| Study First Received: | November 9, 2007 |
| Last Updated: | November 9, 2007 |
| ClinicalTrials.gov Identifier: | NCT00556647 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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fast-track diagnosis PET-CT endoscopic techniques lung cancer |
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Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases |