Comparison of Genomic and Transcriptomic Patterns Between CTC and Metastatic Tumormetastatic Tumor

NSCLC Stage IV Clinical Trial

Official title:

Comparison of Genomic and Transcriptomic Patterns Between the Circulating Tumor Cells and Metastatic Tumor Cells, and Their Specific Relevance to Circulating Tumor DNAs: Quest for Any Distinct or Complementary Roles of CTCs and ctDNAs to Understand the Metastasis in Advanced NSCLC

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04932343
• Other study ID #: IRB 2019-07-101
• Status: Active, not recruiting
• Start date: June 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: June 2021
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to understand the metastasis in advanced NSCLC through comparing genomic and transcriptomic patterns between the circulating tumor cells and metastatic tumor cells by single cell sequencing analysis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All subjects need to sign the informed consent form

• All subjects have non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively

• Treatment naïve advanced lung cancer (including extensive stage IIIb and stage IV)

• Patients who were suitable to provide enough metastatic tumor tissue and blood (30ml) for the single cells sequencing

Exclusion Criteria:

• Patients with previous history of lung cancer

• Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer

• Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix within 5 years before enrollment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC Stage IIIB
• NSCLC Stage IV

Intervention

Diagnostic Test:
• cohort study
no intervention

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Samsung Medical Center	CytoGen, Inc., UNIST (Ulsan National Institute of Science and Technology)

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The gene expression and the cell population	Methods for the single cell RNA sequencing and whole exome sequencing of the tumor cells With the tissue biopsied specimens, scRNAseq (by 10X Genomics platform) and whole exome seq will be carried out.	3 year