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CompletedNCT03479099Updated Aug 28, 2019

Liquid Biopsy in Lung Cancer

An observational study in Lung Cancer (Diagnosis) and Circulating Tumor Cell, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Samsung Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
111
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to assess clinical utility of combined circulating tumor cell (CTC) and circulating tumor DNA (ctDNA) in the diagnosis of primary lung cancer.

Read the detailed description

The peripheral blood and tumor tissue samples are collected from the participants.CTC and ctDNA are analyzed from the blood samples.

02

Conditions studied

  • Lung Cancer (Diagnosis)
  • Circulating Tumor Cell

Keywords

  • Lung cancer
  • Circulating Tumor Cell
  • Cell-Free Tumor DNA
  • Liquid Biopsy
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The subjects who are referred for the evaluation and management of primary lung cancer in the tertiary care center

Inclusion criteria

  • Patients with histology-proven lung cancer or a clinical suspicion of lung cancer
  • Age >=18, \< 80 years
  • No previous history of cancer treatment within 5 years
  • Patients who agree to participate

Exclusion criteria

Exclusion Criteria:

  • Patients who have been diagnosed with malignancy within 5 years
  • Patients with previous history of lung cancer
  • Patients who have uncontrolled coagulopathy
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
111 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Diagnostic sensitivity of combined CTC and ctDNA

    To compared the sensitivity of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer

    Time frame: 1 year

Secondary outcomes

  1. Diagnostic accuracy of combined CTC and ctDNA

    To compared the accuracy of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer

    Time frame: 1 year

  2. Diagnostic specificity of CTC and ctDNA

    To compared the specificity of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer

    Time frame: 1 year

06

Study locations

1 site
  • Samsung Medical Center
    Seoul, 06278, Korea, Republic of
07

References and documents

Publications

  • Moon SM, Kim JH, Kim SK, Kim S, Kwon HJ, Bae JS, Lee S, Lee HS, Choi MY, Jeon BH, Jeong BH, Lee K, Kim HK, Kim J, Um SW. Clinical Utility of Combined Circulating Tumor Cell and Circulating Tumor DNA Assays for Diagnosis of Primary Lung Cancer. Anticancer Res. 2020 Jun;40(6):3435-3444. doi: 10.21873/anticanres.14329. PubMed 32487642 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03479099
Lead sponsor
Samsung Medical Center
Responsible party
Sang-Won Um (Associate Professor, Samsung Medical Center) — Principal investigator
First posted
Mar 27, 2018
Start date
Mar 12, 2018
Primary completion
Mar 11, 2019
Completion
Mar 11, 2019
Last update
Aug 28, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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