Thin Prep Versus Traditional Cytological Procedure for Lung Cancer

Completed

• Conditions: Lung Cancer

• Registration Number: NCT02007538
• Lead Sponsor: Università degli Studi di Ferrara

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-11
• Primary Completion: 2014-03
• Study Completion: 2014-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
total cell counts	the participants will be sampled at the time of recruitment (i.e. the day of the bronchoscopy) and they will be followed until the definitive histological diagnosis, an expected average of 8 weeks	To compare the recovered total cell counts in the samples processed by thin prep technique Vs conventional procedure

Secondary Outcome Measures

Name	Time	Method
Marker Expression	the participants will be sampled at the time of recruitment (i.e. the day of the bronchoscopy) and they will be followed until the definitive histological diagnosis, an expected average of 8 weeks	to evaluate the expression of a pannel of markers evaluated by immonocytochemistry in samples processed with thin prep procedure

Trial Locations

Locations (1)

Bronchoscopy Unit, Section of Repiratory Disease, azienda ospedaliera universitaria di Ferrara; 🇮🇹 Ferrara, Italy