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

NCT04932343 | Unknown

• 1 other identifier: IRB 2019-07-101
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NSCLC Stage IV; NSCLC Stage IIIB

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

cohort study DIAGNOSTIC_TEST

no intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• CytoGen, Inc.: collaborator
• UNIST (Ulsan National Institute of Science and Technology): collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jhingook Kim, MD

  Samsung Medical Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: June 21, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

KR (1)