Thin Prep Versus Traditional Cytological Procedure for Lung Cancer

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02007538

Enrollment

Registered

2013-12-11

Start date

2013-05-31

Completion date

2014-05-31

Last updated

2018-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Lung Cancer, Bronchoscopy, Fine Need Aspiration, Cytochemical Assays

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 84 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Outcome results