Non Small Cell Lung CancerNCT06573073
Evaluation of Clinical Performance and IVD Test of LifeOS Digital PCR Liquid Biopsy Kits for EGFR T790M Mutation
An observational study of Non Small Cell Lung Cancer and EGFR T790M, run by LifeOS Genomics Corporation at 1 site in Taiwan.
Trial summary
Liquid biopsy plays a pivotal role in cancer therapeutics, encompassing critical applications such as early cancer detection, disease progression monitoring, and tailored treatment plan formulation, heralded as a pivotal avenue for the future of cancer management. Established in 2015, LifeOS Genomics Co., Ltd. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, EGFR T790M
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Sep 2024to 31 Dec 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Late stage NSCLC patients with EGFR activating mutations
Who may be able to join
- aged ≥18 years old.
- Patients with Stage IIIB or IV non-small cell lung cancer (NSCLC) with EGFR mutations.
Who cannot join
- Pregnant women.
- Any condition that, in the opinion of the doctors, may pose a severe risk to the patient or interfere with trial results or participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University
Taipei, 10617
Sung-Liang Yu, PhD, +886 23123456 ext. 288697, slyu@ntu.edu.tw
About this study
Liquid biopsy plays a pivotal role in cancer therapeutics, encompassing critical applications such as early cancer detection, disease progression monitoring, and tailored treatment plan formulation, heralded as a pivotal avenue for the future of cancer management. Established in 2015, LifeOS Genomics Co., Ltd. stands among the select few domestic enterprises pioneering the autonomous development of digital Polymerase Chain Reaction (PCR) technology. The company's automated nucleic acid amplification quantitative analysis platform (QLoci™ md1000 Analyzer) demonstrates outstanding proficiency, featuring sixty thousand wells per PCR chip. Integrating digital PCR technology, it elevates analytical sensitivity beyond 0.1%. LifeOS commissioned the Core Laboratory of Pharmacogenomics at the National Taiwan University to conduct clinical validation assessments for their developed "EGFR T790M Mutation Detection Assay Kit." This assay kit secured official registration by the Taiwan Food and Drug Administration (TFDA) as a Laboratory Developed Test (LDT) in 2023, permitting the issuance of medical testing reports.
This initiative aims to validate the detection capabilities of LifeOS Genomics Co., Ltd.'s "EGFR T790M Mutation Detection Assay Kit" prospectively clinically in clinical lung cancer patient plasma samples, addressing unmet clinical needs for early cancer detection, disease progression monitoring, and aiding physicians in diagnosis and pharmacotherapy.
- Conditions
- Non Small Cell Lung Cancer, EGFR T790M
- Keywords
- Liquid biopsy, digital Polymerase Chain Reaction (PCR), EGFR T790M
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC with EGFR mutation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance in detecting EGFR T790M using the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2.
The primary endpoint is to assess the concordance between the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2 in detecting the presence of EGFR T790M in cfDNA from plasma.
Measured: 5 years
Secondary outcomes (2)
Sensitivity of the LifeOS EGFR T790M cfDNA Detection Kit relative to the cobas® EGFR Mutation Test v2.
The secondary endpoint is to assess the sensitivity between the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2 in detecting the presence of EGFR T790M in cfDNA from plasma.
Measured: 5 years
Specificity of the LifeOS EGFR T790M cfDNA Detection Kit relative to the cobas® EGFR Mutation Test v2.
The secondary endpoint is to assess the specificity between the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2 in detecting the presence of EGFR T790M in cfDNA from plasma.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start6 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- LifeOS Genomics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University, National Taiwan University Hospital, Chung Shan Medical University, Chang Gung Memorial Hospital, Tri-Service General Hospital (TSGH), Far Eastern Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Sung-Liang Yu, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573073
- Sponsor's protocol ID
- 202405068DSA
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Performance and IVD Test of LifeOS Digital PCR Liquid Biopsy Kits for EGFR T790M Mutation
- ClinicalTrials.gov ID
- NCT06573073
- Acronym / sponsor ID
- 202405068DSA
- Conditions
- Non Small Cell Lung Cancer, EGFR T790M
- Keywords
- Liquid biopsy, digital Polymerase Chain Reaction (PCR), EGFR T790M
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- LifeOS Genomics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Taiwan University, National Taiwan University Hospital, Chung Shan Medical University, Chang Gung Memorial Hospital, Tri-Service General Hospital (TSGH), Far Eastern Memorial Hospital
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Aug 2024 (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.
Liquid biopsy plays a pivotal role in cancer therapeutics, encompassing critical applications such as early cancer detection, disease progression monitoring, and tailored treatment plan formulation, heralded as a pivotal avenue for the future of cancer management. Established in 2015, LifeOS Genomics Co., Ltd. stands among the select few domestic enterprises pioneering the autonomous development of digital Polymerase Chain Reaction (PCR) technology. The company's automated nucleic acid amplification quantitative analysis platform (QLoci™ md1000 Analyzer) demonstrates outstanding proficiency, featuring sixty thousand wells per PCR chip. Integrating digital PCR technology, it elevates analytical sensitivity beyond 0.1%. LifeOS commissioned the Core Laboratory of Pharmacogenomics at the National Taiwan University to conduct clinical validation assessments for their developed "EGFR T790M Mutation Detection Assay Kit." This assay kit secured official registration by the Taiwan Food and Drug Administration (TFDA) as a Laboratory Developed Test (LDT) in 2023, permitting the issuance of medical testing reports.
This initiative aims to validate the detection capabilities of LifeOS Genomics Co., Ltd.'s "EGFR T790M Mutation Detection Assay Kit" prospectively clinically in clinical lung cancer patient plasma samples, addressing unmet clinical needs for early cancer detection, disease progression monitoring, and aiding physicians in diagnosis and pharmacotherapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC with EGFR mutation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Late stage NSCLC patients with EGFR activating mutations
Key inclusion criteria (2 listed)
- aged ≥18 years old.
- Patients with Stage IIIB or IV non-small cell lung cancer (NSCLC) with EGFR mutations.
Key exclusion criteria (2 listed)
- Pregnant women.
- Any condition that, in the opinion of the doctors, may pose a severe risk to the patient or interfere with trial results or participation.
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
Concordance in detecting EGFR T790M using the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2.
Time frame: 5 years
The primary endpoint is to assess the concordance between the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2 in detecting the presence of EGFR T790M in cfDNA from plasma.
2 secondary outcomes
Sensitivity of the LifeOS EGFR T790M cfDNA Detection Kit relative to the cobas® EGFR Mutation Test v2.
Time frame: 5 years
Specificity of the LifeOS EGFR T790M cfDNA Detection Kit relative to the cobas® EGFR Mutation Test v2.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- 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.
Sung-Liang Yu, PhD principal investigator
National Taiwan University
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 Non Small Cell Lung Cancer and EGFR T790M, run by LifeOS Genomics Corporation at 1 site in Taiwan.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 18 Nov 2024. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sung-Liang Yu, PhD (+886 23123456 ext. 288697, slyu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance in detecting EGFR T790M using the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2. (time frame: 5 years). 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 18 Nov 2024.