A Comprehensive Evaluation of Circulating Tumor DNA and Circulating Tumor Cells as a Predictive Marker in Lung Cancer

NCT04254497 | Completed

• 1 other identifier: 2014/216/B
• Study Type: observational
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the use of ctDNA and CTCs in predicting disease activity and drug response in lung cancer patients and serves to complement existing methods to achieve a non-invasive and accurate means to guide treatment decisions.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Examine the sensitivity and specificity of our EGFR mutation detection kit in ctDNA, CTCs and matched tumor biopsies so as to examine their utility as a non-invasive liquid biopsy.

  6 years

Interventions

EGFR mutation detection kit DIAGNOSTIC_TEST

A microsieve membrane filter device to effectively isolate circulating tumor cells from whole blood sample has been developed by the Institute of Bioengineering and Nanotechnology. The device exploits the size difference between cancer cells and blood cells to achieve the cancer cell capture on a microsieve filter with \> 85% recovery rate from 4.5-ml whole blood within 10 min, demonstrated with cancer cells spiked into whole blood samples. The device contains a densely packed pore array (\> 8000 pores/mm\^2) with an optimized pore diameter of 10 µm. Fluid regulation and cell counting are achieved by a simple vacuum pumping and laboratory fluorescence microscope. The captured cells are stained with anti-EpCAM-PE for CTCs, anti-CD45-FITC for white blood cells, and 4',6-diamidino-2-phenylindole (DAPI) for cell nuclei. The CTCs are identified with anti-EpCAM positive, anti-CD45 negative and DAPI positive, characterized using a fluorescence microscope.

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

150 patients (aged 21-99) suspected to have lung cancer will be recruited from Changi General Hospital. There are no restrictions based on the race of subject. We will exclude study participants who are unable to provide informed consent, such as children and mentally incapable individuals.

You may qualify if:

• Patients suspected to have lung cancer (determined by attending doctors).

You may not qualify if:

• None.

Sponsors & Collaborators

• Changi General Hospital: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: September 11, 2014
• Primary Completion: August 27, 2019
• Study Completion: August 27, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02