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

June 18, 2021 updated by: Jhingook Kim, MD, Samsung Medical Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Treatment naïve stage III-IV non-small cell lung cancer who undergoing surgery for any intent

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The gene expression and the cell population
Time Frame: 3 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

CytoGen, Inc.
UNIST (Ulsan National Institute of Science and Technology)

Investigators

  • Study Chair: Jhingook Kim, MD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 13, 2021

First Submitted That Met QC Criteria

June 18, 2021

First Posted (Actual)

June 21, 2021

Study Record Updates

Last Update Posted (Actual)

June 21, 2021

Last Update Submitted That Met QC Criteria

June 18, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 2019-07-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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