Clinical trial NCT02007538: Thin Prep Versus Traditional Cytological Procedure for Lung Cancer
Official title: Assessment of Adequacy and Characteristics Molecular of the Sample Obtained by Fine-needle Aspiration (FNA) Cytology Lung, Mounted With Thin Prep Compared to the Conventional Smear, in the Diagnosis of Lung Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung Cancer
Bronchoscopy
Fine Need Aspiration
Cytochemical Assays
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected lung cancer

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.

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.

Primary outcomes:
measure: total cell counts
timeFrame: 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
Secondary outcomes:
measure: Marker Expression
timeFrame: 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
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Bronchoscopy Unit, Section of Repiratory Disease, azienda ospedaliera universitaria di Ferrara
Study officials:
affiliation: Azienda Ospedaliera Universitaria di Ferrara
name: Alberto Papi, MD
role: PRINCIPAL_INVESTIGATOR
References: