Thin Prep Versus Traditional Cytological Procedure for Lung Cancer

NCT ID: NCT02007538

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-05-31

Brief Summary

In the diagnosis of lung cancer, the cytological sample obtained during Bronchoscopy (FBS), has an increasingly important role in the characterization of malignancy. The cytological sample can be harvested during bronchoscopy by bronchial brushing, bronchial lavages or fine needle aspiration. Immunocytochemical staining allows not only to discriminate between small cell lung cancer versus non-small cell lung cancer (NSCLC), but also to identify the expression of specific markers such as TTF-1, CK7, CK20, 4A4, 34βE12 and p63. Thin Prep is a technique for cytological assay already validated and largely used in the immunocytochemical determination of gynaecologic specimens. Further Studies are required to asses the accuracy of this technique compared to conventional smear in cytological airway samples obtained by fine needle aspiration.

Detailed Description

Patients undergoing FBS for lung cancer diagnosis purpose will be enrolled in the study. During FBS Fine Need Aspiration (FNA) will be performed. Four samplings by FNA will be performed in each patient. Two samplings will be processed with thin prep technique and two samplings with the traditional procedure. To avoid sampling procedures-related bias, the first harvested sample will be randomly tested with Thin Prep or Traditional technique.

Conditions

Lung Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Thin Prep

Samples obtained from this group will be tested with thin prep

No interventions assigned to this group

Control Group

Samples obtained from this group will be tested with conventional procedure.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• FBS undergoing bronchoscopy for diagnostic purpose of lung cancer.
• Informed consent.
• ASA Classification 1-3.

Exclusion Criteria

• Patients intubated.
• Patients with respiratory failure.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Alberto Papi, MD

professor in respiratory medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto Papi, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Universitaria di Ferrara

Locations

Bronchoscopy Unit, Section of Repiratory Disease, azienda ospedaliera universitaria di Ferrara

Ferrara, , Italy

Countries

Italy

Other Identifiers

FR01

Identifier Type: -

Identifier Source: org_study_id