Clinical Significance of Circulating Tumour Cells in Resectable Lung Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer; Circulating Tumor Cell
• Intervention / Treatment: Diagnostic test: Device for CTC/DTC detection

• Study Type: Observational
• Enrollment (Actual): 166

Contacts and Locations

Study Locations

• Czechia
  • Česká Republika
    • Olomouc, Česká Republika, Czechia, 77900
      • University hospital Olomouc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed non-metastatic NSCLC undergoing radical surgery with curative intent.

Description

Inclusion Criteria:

Non-small cell lung cancer, non-metastatic

Exclusion Criteria:

Prior neoadjuvant chemoradiotherapy Prior lung cancer Cancer duplicity

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
• Investigators: Study Director: Marian Hajduch, MD, PhD, Institute of Molecular and Translational Medicine, Faculty of Medicine and Dentistry, Palacky University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Lung Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: NS10285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The anonymized metadata will be publicly available after publishing the results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No