Clinical Significance of Circulating Tumour Cells in Resectable Lung Cancer Patients

Non Small Cell Lung Cancer Clinical Trial

Official title:

Clinical Significance of Circulating Tumour Cells in Resectable Lung Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05619562
• Other study ID #: NS10285
• Status: Completed
• Start date: January 2009
• Est. completion date: December 2015

Study information

• Verified date: November 2022
• Source: The Institute of Molecular and Translational Medicine, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To determine whether the presence of circulating/disseminated tumour cells (CTCs/DTCs) in the blood and bone marrow of the resectable lung cancer (NSCLC) patients is a negative prognostic factor, and to find correlations with other clinical/pathological disease characteristics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 2015
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Non-small cell lung cancer, non-metastatic

Exclusion Criteria:

Prior neoadjuvant chemoradiotherapy Prior lung cancer Cancer duplicity

Related Conditions & MeSH terms

• Circulating Tumor Cell
• Lung Neoplasms
• Neoplastic Cells, Circulating
• Non Small Cell Lung Cancer

Intervention

Diagnostic Test:
• Device for CTC/DTC detection
The CTCs/DTCs will be detected and counted in peripheral blood, tumour draining blood and bone marrow samples.

Locations

Country	Name	City	State
Czechia	University Hospital Olomouc	Olomouc	Ceská Republika

Sponsors (1)

Lead Sponsor	Collaborator
The Institute of Molecular and Translational Medicine, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CEA, EGFR, LunX, c-met and EpCAM mRNA positive circulating tumour cells in lung cancer patients	The absolute gene expression of CEA, EGFR, LunX, c-met and EpCAM mRNA positive circulating tumour cells(CTCs) isolated from peripheral blood, tumour draining blood and bone marrow samples of lung cancer patients will be measured using real-time RT-PCR method. The gene expression will be normalized per microgram of total mRNA.	30 days
Secondary	Cancer specific survival in CTC positive NSCLC patients	The cancer specific survival, overall survival and disease free survival will be measured from the time of diagnosis to the time of event. Two groups of patients will be compared: A: Patients with the presence of CTCs in peripheral blood, tumour draining blood and bone marrow before NSCLC surgery as described in primary outcome measure.; B: Patients with the absence e of CTCs in peripheral blood, tumour draining blood and bone marrow before NSCLC surgery as described in primary outcome measure.	5 years