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.
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 22, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMay 3, 2018
May 1, 2018
10 months
May 22, 2013
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
total cell counts
To compare the recovered total cell counts in the samples processed by thin prep technique Vs conventional procedure
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 (1)
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
Study Arms (2)
Thin Prep
Samples obtained from this group will be tested with thin prep
Control Group
Samples obtained from this group will be tested with conventional procedure.
Eligibility Criteria
Patients with suspected lung cancer
You may qualify if:
- FBS undergoing bronchoscopy for diagnostic purpose of lung cancer.
- Informed consent.
- ASA Classification 1-3.
You may not qualify if:
- Patients intubated.
- Patients with respiratory failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bronchoscopy Unit, Section of Repiratory Disease, azienda ospedaliera universitaria di Ferrara
Ferrara, 44100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alberto Papi, MD
Azienda Ospedaliera Universitaria di Ferrara
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor in respiratory medicine
Study Record Dates
First Submitted
May 22, 2013
First Posted
December 11, 2013
Study Start
May 1, 2013
Primary Completion
March 1, 2014
Study Completion
May 1, 2014
Last Updated
May 3, 2018
Record last verified: 2018-05