Lung NeoplasmsNCT02666755
Novel Detection System for Lung Cancer Curative Effect Monitoring
An observational study of Lung Neoplasms, run by Jian Zhang.
Trial summary
The purpose of this study is to investigate the sensitivity，specificity and concordance rate of EGFR testing results in plasma in comparison of results in matched tumor tissues tested by amplification refractory mutation system(ARMS). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Neoplasms
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Apr 2018
- 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 diagnosed with NSCLC
Who may be able to join
- Aged 18-85 years old;
- The diagnosis of lung cancer by pathological examination;
- At least one specific measurable lung cancer lesions (according to RECIST criteria, application of spiral CT, the lesion diameter 10 mm or higher);
- People understand and are willing to accept the study, and sign the informed consent
Who cannot join
- With severe hemorrhagic disease;
- Compliance is poor, can't cooperate with the visitor.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Novel Detection System for Detecting Epidermal Growth Factor Receptor Mutation in Plasma in Non-small Cell Lung Cancer
The purpose of this study is to investigate the sensitivity，specificity and concordance rate of EGFR testing results in plasma in comparison of results in matched tumor tissues tested by amplification refractory mutation system(ARMS). Moreover, the investigators correlate our findings in plasma with survival of advanced patients.
Read the detailed description
Non-small cell lung cancer (NSCLC), accounting for 80% of all lung cancers, is a leading cause of cancer deaths worldwide. Inhibition of epidermal growth factor receptor (EGFR) kinase activity by EGFR tyrosine kinase inhibitors, such as gefitinib and erlotinib, can result in improved response and prolonged progression-free survival (PFS) in selected non-small cell lung cancer (NSCLC) patients harboring sensitizing EGFR mutations, especially the exon 19del and exon 21（L858R） mutations. Unfortunately, about 50%-60% patients who accept EGFR tyrosine kinase inhibitors with sensitizing mutations will receive resistance mutations, the T790M resistance is a target of active pharmaceutical development. So EGFR mutation testing is a step in identifying the right patients for EGFR tyrosine kinase inhibitors treatment. Now tissue samples and tumor cytologic samples are accepted as appropriate sample types for EGFR mutation detection, but these samples are not always available on or after diagnosis, and, even when available, they may be of insufficient quality or quantity for mutation testing. Noninvasive techniques for tumor genotyping may be needed to fully realize, such as plasma sample. Cell-free DNA (cf-DNA) in plasma is a kind of fresh and realtime sample, and has been shown to be promising for the detection of sensitizing EGFR mutations even the resistance mutation（T790M). However, a challenge was also raised about how to detect the low abundance of mutant alleles in plasma. In our study Droplet Digital polymerase chain reaction and Realtime polymerase chain reaction will be used to assess the EGFR mutation in plasma DNA samples from patients with advanced NSCLC before and after EGFR tyrosine kinase inhibitors therapy.
- Conditions
- Lung Neoplasms
- Keywords
- Lung Neoplasms digital polymerase chain reaction
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
comparing with results in tissues, tne investigators can get the sensitivity of results in plasma for Epidermal Growth Factor Receptor mutation in Non-small cell lung cancer.
Measured: 2 years
Secondary outcomes (1)
specificity
comparing with results in tissues, the investigators can get the specificity of results in plasma for Epidermal Growth Factor Receptor mutation in Non-small cell lung cancer.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian Zhang, Air Force Military Medical University, China
- Investigators
- Jian Zhang, Doctor, Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666755
- Sponsor's protocol ID
- 15229491635
- Status last verified
- Jan 2016
- First submitted
- 19 Jan 2016
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Zhu G, Ye X, Dong Z, Lu YC, Sun Y, Liu Y, McCormack R, Gu Y, Liu X. Highly Sensitive Droplet Digital PCR Method for Detection of EGFR-Activating Mutations in Plasma Cell-Free DNA from Patients with Advanced Non-Small Cell Lung Cancer. J Mol Diagn. 2015 May;17(3):265-72. doi: 10.1016/j.jmoldx.2015.01.004. Epub 2015 Mar 11.
PubMed 25769900Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
PubMed 21296855Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19.
PubMed 19692680Zhou C, Wu YL, Chen G, Feng J, Liu XQ, Wang C, Zhang S, Wang J, Zhou S, Ren S, Lu S, Zhang L, Hu C, Hu C, Luo Y, Chen L, Ye M, Huang J, Zhi X, Zhang Y, Xiu Q, Ma J, Zhang L, You C. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2011 Aug;12(8):735-42. doi: 10.1016/S1470-2045(11)70184-X. Epub 2011 Jul 23.
PubMed 21783417Yu M, Bardia A, Wittner BS, Stott SL, Smas ME, Ting DT, Isakoff SJ, Ciciliano JC, Wells MN, Shah AM, Concannon KF, Donaldson MC, Sequist LV, Brachtel E, Sgroi D, Baselga J, Ramaswamy S, Toner M, Haber DA, Maheswaran S. Circulating breast tumor cells exhibit dynamic changes in epithelial and mesenchymal composition. Science. 2013 Feb 1;339(6119):580-4. doi: 10.1126/science.1228522.
PubMed 23372014
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Detection System for Detecting Epidermal Growth Factor Receptor Mutation in Plasma in Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02666755
- Acronym / sponsor ID
- 15229491635
- Conditions
- Lung Neoplasms
- Keywords
- Lung Neoplasms digital polymerase chain reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Jian ZhangUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 28 Jan 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 investigate the sensitivity，specificity and concordance rate of EGFR testing results in plasma in comparison of results in matched tumor tissues tested by amplification refractory mutation system(ARMS). Moreover, the investigators correlate our findings in plasma with survival of advanced patients.
Detailed description
Non-small cell lung cancer (NSCLC), accounting for 80% of all lung cancers, is a leading cause of cancer deaths worldwide. Inhibition of epidermal growth factor receptor (EGFR) kinase activity by EGFR tyrosine kinase inhibitors, such as gefitinib and erlotinib, can result in improved response and prolonged progression-free survival (PFS) in selected non-small cell lung cancer (NSCLC) patients harboring sensitizing EGFR mutations, especially the exon 19del and exon 21（L858R） mutations. Unfortunately, about 50%-60% patients who accept EGFR tyrosine kinase inhibitors with sensitizing mutations will receive resistance mutations, the T790M resistance is a target of active pharmaceutical development. So EGFR mutation testing is a step in identifying the right patients for EGFR tyrosine kinase inhibitors treatment. Now tissue samples and tumor cytologic samples are accepted as appropriate sample types for EGFR mutation detection, but these samples are not always available on or after diagnosis, and, even when available, they may be of insufficient quality or quantity for mutation testing. Noninvasive techniques for tumor genotyping may be needed to fully realize, such as plasma sample. Cell-free DNA (cf-DNA) in plasma is a kind of fresh and realtime sample, and has been shown to be promising for the detection of sensitizing EGFR mutations even the resistance mutation（T790M). However, a challenge was also raised about how to detect the low abundance of mutant alleles in plasma. In our study Droplet Digital polymerase chain reaction and Realtime polymerase chain reaction will be used to assess the EGFR mutation in plasma DNA samples from patients with advanced NSCLC before and after EGFR tyrosine kinase inhibitors therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with NSCLC
Key inclusion criteria (4 listed)
- Aged 18-85 years old;
- The diagnosis of lung cancer by pathological examination;
- At least one specific measurable lung cancer lesions (according to RECIST criteria, application of spiral CT, the lesion diameter 10 mm or higher);
- People understand and are willing to accept the study, and sign the informed consent
Key exclusion criteria (2 listed)
- With severe hemorrhagic disease;
- Compliance is poor, can't cooperate with the visitor.
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
sensitivity
Time frame: 2 years
comparing with results in tissues, tne investigators can get the sensitivity of results in plasma for Epidermal Growth Factor Receptor mutation in Non-small cell lung cancer.
1 secondary outcome
specificity
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
- Background: PubMed 25769900Zhu G, Ye X, Dong Z, Lu YC, Sun Y, Liu Y, McCormack R, Gu Y, Liu X. Highly Sensitive Droplet Digital PCR Method for Detection of EGFR-Activating Mutations in Plasma Cell-Free DNA from Patients with Advanced Non-Small Cell Lung Cancer. J Mol Diagn. 2015 May;17(3):265-72. doi: 10.1016/j.jmoldx.2015.01.004. Epub 2015 Mar 11.
- Background: PubMed 21296855Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
- Background: PubMed 19692680Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19.
- Background: PubMed 21783417Zhou C, Wu YL, Chen G, Feng J, Liu XQ, Wang C, Zhang S, Wang J, Zhou S, Ren S, Lu S, Zhang L, Hu C, Hu C, Luo Y, Chen L, Ye M, Huang J, Zhi X, Zhang Y, Xiu Q, Ma J, Zhang L, You C. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2011 Aug;12(8):735-42. doi: 10.1016/S1470-2045(11)70184-X. Epub 2011 Jul 23.
- Results publication: PubMed 23372014Yu M, Bardia A, Wittner BS, Stott SL, Smas ME, Ting DT, Isakoff SJ, Ciciliano JC, Wells MN, Shah AM, Concannon KF, Donaldson MC, Sequist LV, Brachtel E, Sgroi D, Baselga J, Ramaswamy S, Toner M, Haber DA, Maheswaran S. Circulating breast tumor cells exhibit dynamic changes in epithelial and mesenchymal composition. Science. 2013 Feb 1;339(6119):580-4. doi: 10.1126/science.1228522.
- Individual participant dataSharing planned: Undecided
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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.
Jian Zhang, Doctor study director
Xijing Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms, run by Jian Zhang.
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 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: status not confirmed, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Ning Chang, Postgraduate (15229491635, changninggirl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity (time frame: 2 years). 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 NCT02666755, which also lists 5 linked publications.
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 29 Jan 2016.