Fast-track Diagnosis for Lung Cancer Suspects With PET-CT and EUS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jan W.K. van den Berg, Isala Klinieken
ClinicalTrials.gov Identifier:
NCT00556647
First received: November 9, 2007
Last updated: April 5, 2013
Last verified: April 2013
  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: Observational
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)

Resource links provided by NLM:


Further study details as provided by Isala Klinieken:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 297
Study Start Date: September 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Fast-track diagnosis
Procedure: fast track diagnosis
fast-track diagnosis, PET-CT, bronchoscopy
Procedure: conventional diagnosis
out-patient diagnosis

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients suspected of lung cancer

Criteria

Inclusion Criteria:

  • patients with a suspicion of lung cancer on chest X-ray
  • age between 18-85 years
  • informed consent.

Exclusion Criteria:

  • comorbidity (alcoholabuse, drugsabuse and limiting psychiatric disease)
  • non-compliance
  • previous diagnostic tests for the suspicious X-ray (endoscopy, CT)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556647

Locations
Netherlands
Isala Klinieken
Zwolle, Netherlands, 8011 JW
Sponsors and Collaborators
Isala Klinieken
Investigators
Study Director: J. Stigt, Drs. Isala Klinieken
  More Information

No publications provided

Responsible Party: Jan W.K. van den Berg, Dr., Isala Klinieken
ClinicalTrials.gov Identifier: NCT00556647     History of Changes
Other Study ID Numbers: NL12541.075.06
Study First Received: November 9, 2007
Last Updated: April 5, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Isala Klinieken:
fast-track diagnosis
PET-CT
endoscopic techniques
lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014