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NCT04932343 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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