Non Small Cell Lung CancerNCT02778854
Liquid Biopsy for Detection of Driver Mutation in NSCLC
An observational study of Non Small Cell Lung Cancer, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the diagnostic and prognostic efficacy of liquid biopsy in different specimens and in different methods compared with tissue detection . Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- detection of driver mutation
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Nov 2020
- How long will I take part?
- 5 Years
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who have been diagnosed with NSCLC and received detection of driver mutation in Chinese PLA general hospital
Who may be able to join
- patients newly diagnosed with NSCLC confirmed by tissue biopsy and going to receive the detection of gene mutation or patients have obtained drug-resistance after receiving molecular target therapy and plan to re-biopsy.
- Age ≥ 18 years
- newly diagnosed patients have not received TKI and chemotherapy
- patients who are drug-resistant have not received next-generation TKI
- patients from cohort1 with sensitive driver mutation and plan to receive TKI therapy
- patients will have regular follow-up in Chinese people liberation army general hospital every month.
Who cannot join
- patients who have more than one type of carcinoma
- patients who reject to sign the informed consent from
- cohort 2
- patients who are refused to provide the informed consent from
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
department of respiratory department ,Chinese PLA general hospital
Beijing, Beijing Municipality, 100853
Liang-an Chen, MD,PHD, 8610-55499027, cla301@126.com
Liang-an Chen, MD,PHD
About this study
Official title: Liquid Biopsy for Detection of Driver Mutation in Diagnostic and Prognostic of NSCLC
The purpose of this study is to evaluate the diagnostic and prognostic efficacy of liquid biopsy in different specimens and in different methods compared with tissue detection .
Read the detailed description
Collect plasma and other specimens from patients who are newly diagnosed with NSCLC or with drug-resistant and plan to receive gene detection to complete the diagnostic test for liquid biopsy .Participants who come from diagnostic test and plan to receive tyrosine kinase inhibitors (TKI) therapy will be collected plasma and other specimens every month during the regiments and monitor the changes of driver motion to predict the prognosis of targeted therapy.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- detection of driver mutation
- Keywords
- NSCLC, liquid biopsy, driver mutation
- 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.
detection of driver mutationGenetic
participants are received gene detection via the liquid biopsy
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 | Participants are recruited for diagnostic test Receives: Genetic: detection of driver mutation | |
| cohort 2 | participants are recruited for follow-up Receives: Genetic: detection of driver mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance between tissue and plasma using detection method such as droplet digital PCR(ddPCR) or next generation sequencing(NGS) to detect the driver mutation in NSCLC
Measured: 6 months
Secondary outcomes (4)
concordance between tissue and other specimens using detection method such as droplet digital PCR(ddPCR) or next generation sequencing(NGS) to detect the driver mutation in NSCLC
Measured: 6 months
changes of driver mutation in quality and quantity in the process of targeted treatment to predict the prognosis
Measured: 5 years
Progress-free survival(PFS) in patients who have had driver mutation and received the molecular target therapy
compare the PFS between each participants via the change of driver mutation
Measured: 3 years
Overall survival(OS) in patients who had driver mutation and received the molecular target therapy
compare the OS between each participants via the change of driver mutation
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 posted20 May 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2018 (estimated)
- Study completionNov 2020 (estimated)
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 Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Liang_An, Chinese PLA General Hospital
- Investigators
- Liang-an Chen, MD,PHD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778854
- Sponsor's protocol ID
- S2015-099-01
- Status last verified
- Mar 2018
- First submitted
- 10 May 2016
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: considering of personal privacy, the research-related individual participant data do not intend for public sharing.
Publications
Wu Z, Yang Z, Li CS, Zhao W, Liang ZX, Dai Y, Zhu Q, Miao KL, Cui DH, Chen LA. Differences in the genomic profiles of cell-free DNA between plasma, sputum, urine, and tumor tissue in advanced NSCLC. Cancer Med. 2019 Mar;8(3):910-919. doi: 10.1002/cam4.1935. Epub 2019 Feb 14.
PubMed 30767431
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy for Detection of Driver Mutation in Diagnostic and Prognostic of NSCLC
- ClinicalTrials.gov ID
- NCT02778854
- Acronym / sponsor ID
- S2015-099-01
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC, liquid biopsy, driver mutation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 20 May 2016 (estimated)
- 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 evaluate the diagnostic and prognostic efficacy of liquid biopsy in different specimens and in different methods compared with tissue detection .
Detailed description
Collect plasma and other specimens from patients who are newly diagnosed with NSCLC or with drug-resistant and plan to receive gene detection to complete the diagnostic test for liquid biopsy .Participants who come from diagnostic test and plan to receive tyrosine kinase inhibitors (TKI) therapy will be collected plasma and other specimens every month during the regiments and monitor the changes of driver motion to predict the prognosis of targeted therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | – | Genetic: detection of driver mutationParticipants are recruited for diagnostic test |
| cohort 2 | – | Genetic: detection of driver mutationparticipants are recruited for follow-up |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have been diagnosed with NSCLC and received detection of driver mutation in Chinese PLA general hospital
Key inclusion criteria (6 listed)
- patients newly diagnosed with NSCLC confirmed by tissue biopsy and going to receive the detection of gene mutation or patients have obtained drug-resistance after receiving molecular target therapy and plan to re-biopsy.
- Age ≥ 18 years
- newly diagnosed patients have not received TKI and chemotherapy
- patients who are drug-resistant have not received next-generation TKI
- patients from cohort1 with sensitive driver mutation and plan to receive TKI therapy
Key exclusion criteria (4 listed)
- patients who have more than one type of carcinoma
- patients who reject to sign the informed consent from
- cohort 2
- patients who are refused to provide the informed consent from
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| detection of driver mutationparticipants are received gene detection via the liquid biopsy | Genetic | cohort 1, cohort 2 |
Primary outcome
concordance between tissue and plasma using detection method such as droplet digital PCR(ddPCR) or next generation sequencing(NGS) to detect the driver mutation in NSCLC
Time frame: 6 months
4 secondary outcomes
concordance between tissue and other specimens using detection method such as droplet digital PCR(ddPCR) or next generation sequencing(NGS) to detect the driver mutation in NSCLC
Time frame: 6 months
changes of driver mutation in quality and quantity in the process of targeted treatment to predict the prognosis
Time frame: 5 years
Progress-free survival(PFS) in patients who have had driver mutation and received the molecular target therapy
Time frame: 3 years
Overall survival(OS) in patients who had driver mutation and received the molecular target therapy
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- Derived from this study: PubMed 30767431Wu Z, Yang Z, Li CS, Zhao W, Liang ZX, Dai Y, Zhu Q, Miao KL, Cui DH, Chen LA. Differences in the genomic profiles of cell-free DNA between plasma, sputum, urine, and tumor tissue in advanced NSCLC. Cancer Med. 2019 Mar;8(3):910-919. doi: 10.1002/cam4.1935. Epub 2019 Feb 14.
- Individual participant dataSharing planned: No. considering of personal privacy, the research-related individual participant data do not intend for public sharing.
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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.
Liang-an Chen, MD,PHD principal investigator
Chinese PLA General Hospital
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, run by Chinese PLA General Hospital at 1 site in China.
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 6 inclusion and 4 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 8 Mar 2018. 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 China. 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 Liang-an Chen, MD,PHD (8610-55499027, cla301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concordance between tissue and plasma using detection method such as droplet digital PCR(ddPCR) or next generation sequencing(NGS) to detect the driver mutation in NSCLC (time frame: 6 months). 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 NCT02778854, 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 8 Mar 2018.