ClinicalTrials.gg
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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Lung Neoplasms by Samsung Medical Center — 5 open to participants now, 6 under way, none of them phase 3. Lung Neoplasms · Samsung Medical Center.

Enrollment
10th of 12
111 · median 390
Started
2018
with 1 other
Observational
12 of 22
2 open now
Registered
10th of 22
by date

Among the 22 studies in Lung Neoplasms by Samsung Medical Center, this one is the 10th largest by enrollment of the 12 observational ones, is one of 2 that started in 2018, is one of 12 observational ones, and was the 10th registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

Observationalthis study12 · 2 open
No phase5 · 1 open
Phase 24 · 1 open
Phase 41 · 1 open

By the year they started

First in 2007; this study’s year is marked. 2 started in 2018.

Size and results

Median enrollment 128 across the 10 interventional studies, 390 across the 12 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 22 studies in Lung Neoplasms by Samsung Medical Center, or all of them as a file.
02

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.

03

Conditions studied

  • Lung Cancer (Diagnosis)
  • Circulating Tumor Cell

Keywords

  • Lung cancer
  • Circulating Tumor Cell
  • Cell-Free Tumor DNA
  • Liquid Biopsy
04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 within 5 years
  • Patients with previous history of lung cancer
  • Patients who have uncontrolled coagulopathy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
111 participants (actual)
Patient registry
No
06

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

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 06278, Korea, Republic of
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Mar 2019, 11 months.

Of 591 non-industry observational studies under Lung Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 162. This study's 11 months is below that.

Counting every sponsor, half of 681 studies reached it within 57 months; a quarter within 25 and three quarters within 135.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2018
First posted
Mar 27, 2018
StartActual
Mar 12, 2018
Primary completionActual
Mar 11, 2019
CompletionActual
Mar 11, 2019
Last update
Aug 28, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03479099
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 ↗

Not currently enrolling

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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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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