Lung Cancer (Diagnosis)NCT03479099
Liquid Biopsy in Lung Cancer
An observational study of Lung Cancer (Diagnosis) and Circulating Tumor Cell, run by Samsung Medical Center at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer (Diagnosis), Circulating Tumor Cell
- How many people
- 111 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Mar 2018to 11 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects who are referred for the evaluation and management of primary lung cancer in the tertiary care center
Who may be able to join
- 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
Who cannot join
- Patients who have been diagnosed with malignancy within 5 years
- Patients with previous history of lung cancer
- Patients who have uncontrolled coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Utility of Combined CTC and ctDNA Assay in the Diagnosis of Primary Lung Cancer
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.
- Conditions
- Lung Cancer (Diagnosis), Circulating Tumor Cell
- Keywords
- Lung cancer, Circulating Tumor Cell, Cell-Free Tumor DNA, Liquid Biopsy
- Medical subject headings
- Lung Neoplasms, Disease, Neoplastic Cells, Circulating
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
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
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start12 Mar 2018
- Primary completion11 Mar 2019
- Study completion11 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Won Um, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479099
- Sponsor's protocol ID
- 2018-01-081
- Status last verified
- Aug 2019
- First submitted
- 12 Mar 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Combined CTC and ctDNA Assay in the Diagnosis of Primary Lung Cancer
- ClinicalTrials.gov ID
- NCT03479099
- Acronym / sponsor ID
- 2018-01-081
- Conditions
- Lung Cancer (Diagnosis), Circulating Tumor Cell
- Keywords
- Lung cancer, Circulating Tumor Cell, Cell-Free Tumor DNA, Liquid Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 11 Mar 2019 (actual)
- Study completion
- 11 Mar 2019 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The peripheral blood and tumor tissue samples are collected from the participants.CTC and ctDNA are analyzed from the blood samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects who are referred for the evaluation and management of primary lung cancer in the tertiary care center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who have been diagnosed with malignancy within 5 years
- Patients with previous history of lung cancer
- Patients who have uncontrolled coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic sensitivity of combined CTC and ctDNA
Time frame: 1 year
To compared the sensitivity of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer
2 secondary outcomes
Diagnostic accuracy of combined CTC and ctDNA
Time frame: 1 year
Diagnostic specificity of CTC and ctDNA
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Derived from this study: PubMed 32487642Moon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (Diagnosis) and Circulating Tumor Cell, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic sensitivity of combined CTC and ctDNA (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03479099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.