An observational study in Lung Cancer, sponsored by Università degli Studi di Ferrara. Completed at 1 site in Italy. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2018-05-03.
Sponsored by Università degli Studi di Ferrara · Observational
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.
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.
7,334 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's enrollment of 60 is below the median of 190 across 1,547 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Università degli Studi di Ferrara is the lead sponsor of 65 studies on the registry; 10 are open to participants now.
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Patients with suspected lung cancer
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Samples obtained from this group will be tested with thin prep
Samples obtained from this group will be tested with conventional procedure.
total cell counts
To compare the recovered total cell counts in the samples processed by thin prep technique Vs conventional procedure
Time frame: 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
Marker Expression
to evaluate the expression of a pannel of markers evaluated by immonocytochemistry in samples processed with thin prep procedure
Time frame: 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
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Università degli Studi di Ferrara