Lung NeoplasmsNCT04922073
Practical Usability of EGFR Mutation Detection in ctDNA From Resectable NSCLC
An observational study of Lung Neoplasms, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The aim of the study is to assess the practical usability of EGFR mutation detection in ctDNA from early NSCLC. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Lung Neoplasms
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2021to 31 Mar 2022
- 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 20 to 85 years
- All sexes
- Adult, Older adult
Study population: Patient with clinical stage IB to IIIA Non-small Cell Lung Cancer
Who may be able to join
- Patient with clinical stage IB to IIIA Non-small Cell Lung Cancer
- Patients with resectable lung cancer
- One of followings: 1) Never-smokers or ex-smokers who quit 10 years ago, 2) Female 3) Subsolid nodule in chest CT 4) Biopsy-proven adenocarcinoma
Who cannot join
- Patients with metastatic lung cancer (Stage IIIB-IV)
- Patients who underwent chemotherapy or radiotherapy
- Patients with other malignancies
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Junghee Kang, phD, riverjh3.kang@gmail.com
About this study
The aim of the study is to assess the practical usability of EGFR mutation detection in ctDNA from early NSCLC.
- Conditions
- Lung Neoplasms
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the EGFR assay
ADPS EGFR Mutation Test using plasma sample from clinical stage IB-IIIA NSCLC patients (reference: EGFR assay in tissue specimen)
Measured: Immediately before the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jun 2021
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GENECAST Co., Ltd.
- Responsible party
- Principal investigator, Jhingook Kim, MD, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922073
- Sponsor's protocol ID
- 2021-04-150
- Status last verified
- Aug 2021
- First submitted
- 26 May 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Usability of EGFR Mutation Detection in ctDNA From Resectable NSCLC
- ClinicalTrials.gov ID
- NCT04922073
- Acronym / sponsor ID
- 2021-04-150
- Conditions
- Lung Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- GENECAST Co., Ltd.
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 10 Jun 2021 (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 aim of the study is to assess the practical usability of EGFR mutation detection in ctDNA from early NSCLC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with clinical stage IB to IIIA Non-small Cell Lung Cancer
Key inclusion criteria (3 listed)
- Patient with clinical stage IB to IIIA Non-small Cell Lung Cancer
- Patients with resectable lung cancer
- One of followings: 1) Never-smokers or ex-smokers who quit 10 years ago, 2) Female 3) Subsolid nodule in chest CT 4) Biopsy-proven adenocarcinoma
Key exclusion criteria (3 listed)
- Patients with metastatic lung cancer (Stage IIIB-IV)
- Patients who underwent chemotherapy or radiotherapy
- Patients with other malignancies
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
Performance of the EGFR assay
Time frame: Immediately before the surgery
ADPS EGFR Mutation Test using plasma sample from clinical stage IB-IIIA NSCLC patients (reference: EGFR assay in tissue specimen)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
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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.
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 Neoplasms, 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 3 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: status not confirmed, as of the sponsor's last update on 27 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jhingook Kim, MD (82-2-3410-1696, jhingookkim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the EGFR assay (time frame: Immediately before the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2021.