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

NCT00556647 | Completed DMC

• 1 other identifier: NL12541.075.06
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

fast-track diagnosis; PET-CT; endoscopic techniques; lung cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients that will have a definitive diagnosis and final stage NSCLC in one day

  1 day

Secondary Outcomes (1)

• 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.

  2 years

Study Arms (1)

A

Fast-track diagnosis

Procedure: fast track diagnosis; Procedure: conventional diagnosis

Interventions

fast track diagnosis PROCEDURE

fast-track diagnosis, PET-CT, bronchoscopy

A

conventional diagnosis PROCEDURE

out-patient diagnosis

A

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suspected of lung cancer

You may qualify if:

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

You may not qualify if:

• comorbidity (alcoholabuse, drugsabuse and limiting psychiatric disease)
• non-compliance
• previous diagnostic tests for the suspicious X-ray (endoscopy, CT)

Sponsors & Collaborators

• Isala: lead

Study Sites (1)

Isala Klinieken

Zwolle, 8011 JW, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• J. Stigt, Drs.

  Isala

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: September 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

NL (1)