Clinical Significance of Circulating Tumour Cells in Resectable Lung Cancer Patients

NCT05619562 | Completed

• 1 other identifier: NS10285
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non Small Cell Lung Cancer; Circulating Tumor Cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cancer specific survival in CTC positive NSCLC patients

  5 years

Interventions

Device for CTC/DTC detection DIAGNOSTIC_TEST

The CTCs/DTCs will be detected and counted in peripheral blood, tumour draining blood and bone marrow samples.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Non-small cell lung cancer, non-metastatic

You may not qualify if:

• Prior neoadjuvant chemoradiotherapy Prior lung cancer Cancer duplicity

Sponsors & Collaborators

• The Institute of Molecular and Translational Medicine, Czech Republic: lead

Study Sites (1)

University Hospital Olomouc

Olomouc, Česká Republika, 77900, Czechia

Location

Biospecimen

Retention: SAMPLES WITH DNA

ctDNA from plasma blood samples. DNA and RNA from nucleated blood cells. DNA and RNA from tumour tissue.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marian Hajduch, MD, PhD

  Institute of Molecular and Translational Medicine, Faculty of Medicine and Dentistry, Palacky University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IMTM director

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: January 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: December 1, 2015
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)