Nonsmall Cell Lung CancerNCT02980536
cSMART Liquid Biopsy and Dynamic Monitor of NSCLC Patients in Inner-Mongolia China
An observational study of Nonsmall Cell Lung Cancer and Adenocarcinoma, run by Berry Genomics Co., Ltd. at 9 sites in China.
Trial summary
The purpose of this study is to evaluate the mutation pattern of epidermal growth factor receptor (EGFR) and other TKI targeted gene during TKI treatment of advanced NSCLC patient with liquid biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsmall Cell Lung Cancer, Adenocarcinoma
- How many people
- 129 participants
- Where
- 9 sitesChina
- Study dates
- Nov 2016to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Stage III and Stage IV NSCLC, adenocarcinoma.
Who may be able to join
- NSCLC adenocarcinoma patients confirmed by pathologist
- Initial, non-operative patients with stage III \& IV adenocarcinoma
- Older than 18 years old
- Subjects have no major organ dysfunction. In detail, Liver Function: TBiL≤1.5 ULN ( Upper Limit of Normal); Serum GPT (Glutamate-Pyruvate Transaminase ):≤2 ULN, Renal Function: ScR≤1.2 ULN; BUN≤1.2 ULN, BM (Bone Marrow) Reserve: WBC (White Blood cell Count) ≥4.0×e9/L; ANC≥2.0×e9/L，PLT≥100×e9/L，HGB≥100g/L.
- PS (Performance Status) Score: less than 2, Expected Survival Time: More than 3 months;
- Have a clear measurable tumor lesion in lung,under RIEST.
- Without severe drug allergy
- Patients participate in this trail must sign the informed consent
Who cannot join
- Patients with brain metases related syndrome
- Patients with bone metases related complication
- Patients with cognitive disorder
- Patients with major organ dysfunction and severe cardiopathy include congestive heart-failure, uncontrolled arrhythmia, angina with long term treatment, VHD (Valvular Heart Disease), myocardial infraction, RHTN (Resistant Hypertension).
- Patients with other severe complication and excluded by the researcher.
- Patients who are allergy with the TKI in this trail.
Show all 9Show fewer
- Patients who participated in other trails or with anti-tumor treatments
- Patients who receive radiotherapy at the site of curative effect observation
- Patients who receive allogenic blood transfusion within 14 days
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Baogang Hospital
Baotou, Inner Mongolia, 014010
Baotou Cancer Hospital
Baotou, Inner Mongolia, 014030
Northern Hospital Baotou
Baotou, Inner Mongolia, 014030
Baotou Centry Hospital
Baotou, Inner Mongolia, 014040
Bayan Nur Hospital
Bayan Nur, Inner Mongolia, 015000
The Inner Mongolia Autonomous Region Cancer Hospital
Hohhot, Inner Mongolia, 010017
The Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, 010017
The First Affiliated Hospital of Inner Monglia Medical University
Hohhot, Inner Mongolia, 010050
Dalad Banner People's Hospital
Ordos, Inner Mongolia, 104300
About this study
Official title: The Oncogenic Mutation Detection of Advanced NSCLC Patients by cSMART Liquid Biopsy and Dynamic Monitor of Tyrosine Kinase Inhibitor(TKI) Efficiency in Inner-Mongolia China
The purpose of this study is to evaluate the mutation pattern of epidermal growth factor receptor (EGFR) and other TKI targeted gene during TKI treatment of advanced NSCLC patient with liquid biopsy.
Read the detailed description
In the study, 200 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and Circulating Single-Molecule Amplification and Resequencing Technology (cSMART) liquid biopsy. those patients who carry EGFR activating mutation and other TKI targeted activating mutation will receive TKI treatment. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. the study will be ended when all the patients had a progressive disease (PD) in their targeted lesion
- Conditions
- Nonsmall Cell Lung Cancer, Adenocarcinoma
- Keywords
- NSCLC, TKI, Mutation, Liquid Biopsy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
The TKI resistance gene mutation pattern in plasma DNA of TKI treated patient
The researcher would like to find out the change of mutation in plasma DNA of the patients who received TKI treatment by a liquid biopsy method.
Measured: 1.5 years
Secondary outcomes (1)
The concordance of gene mutation pattern between liquid biopsy and traditional cancer tissue biopsy
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 posted2 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nonsmall 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berry Genomics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Chest Hospital, Baotou Cancer Hospital
- Responsible party
- Sponsor
- Investigators
- Shun Lu, MD/PhD, Study chair, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980536
- Sponsor's protocol ID
- BerryGenomics NMB
- Status last verified
- Jul 2018
- First submitted
- 27 Nov 2016
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wang Z, Cheng G, Han X, Mu X, Zhang Y, Cui D, Liu C, Zhang L, Fan Z, Ma L, Yang L, Di J, Cram DS, Shi Y, Liu D. Application of Single-Molecule Amplification and Resequencing Technology for Broad Surveillance of Plasma Mutations in Patients with Advanced Lung Adenocarcinoma. J Mol Diagn. 2017 Jan;19(1):169-181. doi: 10.1016/j.jmoldx.2016.09.008. Epub 2016 Nov 19.
PubMed 27870944Chai X, Ren P, Wei B, Ma J, Mai L, Cram DS, Song Y, Guo Y. A comparative study of EGFR oncogenic mutations in matching tissue and plasma samples from patients with advanced non-small cell lung carcinoma. Clin Chim Acta. 2016 Jun 1;457:106-11. doi: 10.1016/j.cca.2016.04.003. Epub 2016 Apr 9.
PubMed 27071701Song Y, Zhou X, Huang S, Li X, Qi Q, Jiang Y, Liu Y, Ma C, Li Z, Xu M, Cram DS, Liu J. Quantitation of fetal DNA fraction in maternal plasma using circulating single molecule amplification and re-sequencing technology (cSMART). Clin Chim Acta. 2016 May 1;456:151-156. doi: 10.1016/j.cca.2016.03.005. Epub 2016 Mar 15.
PubMed 26993877Lv W, Wei X, Guo R, Liu Q, Zheng Y, Chang J, Bai T, Li H, Zhang J, Song Z, Cram DS, Liang D, Wu L. Noninvasive prenatal testing for Wilson disease by use of circulating single-molecule amplification and resequencing technology (cSMART). Clin Chem. 2015 Jan;61(1):172-81. doi: 10.1373/clinchem.2014.229328. Epub 2014 Nov 6.
PubMed 25376582
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oncogenic Mutation Detection of Advanced NSCLC Patients by cSMART Liquid Biopsy and Dynamic Monitor of Tyrosine Kinase Inhibitor(TKI) Efficiency in Inner-Mongolia China
- ClinicalTrials.gov ID
- NCT02980536
- Acronym / sponsor ID
- BerryGenomics NMB
- Conditions
- Nonsmall Cell Lung Cancer, Adenocarcinoma
- Keywords
- NSCLC, TKI, Mutation, Liquid Biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Berry Genomics Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Chest Hospital, Baotou Cancer Hospital
- Study start
- Nov 2016 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 2 Dec 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 mutation pattern of epidermal growth factor receptor (EGFR) and other TKI targeted gene during TKI treatment of advanced NSCLC patient with liquid biopsy.
Detailed description
In the study, 200 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and Circulating Single-Molecule Amplification and Resequencing Technology (cSMART) liquid biopsy. those patients who carry EGFR activating mutation and other TKI targeted activating mutation will receive TKI treatment. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. the study will be ended when all the patients had a progressive disease (PD) in their targeted lesion
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Stage III and Stage IV NSCLC, adenocarcinoma.
Key inclusion criteria (8 listed)
- NSCLC adenocarcinoma patients confirmed by pathologist
- Initial, non-operative patients with stage III \& IV adenocarcinoma
- Older than 18 years old
- Subjects have no major organ dysfunction. In detail, Liver Function: TBiL≤1.5 ULN ( Upper Limit of Normal); Serum GPT (Glutamate-Pyruvate Transaminase ):≤2 ULN, Renal Function: ScR≤1.2 ULN; BUN≤1.2 ULN, BM (Bone Marrow) Reserve: WBC (White Blood cell Count) ≥4.0×e9/L; ANC≥2.0×e9/L，PLT≥100×e9/L，HGB≥100g/L.
- PS (Performance Status) Score: less than 2, Expected Survival Time: More than 3 months;
Key exclusion criteria (9 listed)
- Patients with brain metases related syndrome
- Patients with bone metases related complication
- Patients with cognitive disorder
- Patients with major organ dysfunction and severe cardiopathy include congestive heart-failure, uncontrolled arrhythmia, angina with long term treatment, VHD (Valvular Heart Disease), myocardial infraction, RHTN (Resistant Hypertension).
- Patients with other severe complication and excluded by the researcher.
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
The TKI resistance gene mutation pattern in plasma DNA of TKI treated patient
Time frame: 1.5 years
The researcher would like to find out the change of mutation in plasma DNA of the patients who received TKI treatment by a liquid biopsy method.
1 secondary outcome
The concordance of gene mutation pattern between liquid biopsy and traditional cancer tissue biopsy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Background: PubMed 27870944Wang Z, Cheng G, Han X, Mu X, Zhang Y, Cui D, Liu C, Zhang L, Fan Z, Ma L, Yang L, Di J, Cram DS, Shi Y, Liu D. Application of Single-Molecule Amplification and Resequencing Technology for Broad Surveillance of Plasma Mutations in Patients with Advanced Lung Adenocarcinoma. J Mol Diagn. 2017 Jan;19(1):169-181. doi: 10.1016/j.jmoldx.2016.09.008. Epub 2016 Nov 19.
- Background: PubMed 27071701Chai X, Ren P, Wei B, Ma J, Mai L, Cram DS, Song Y, Guo Y. A comparative study of EGFR oncogenic mutations in matching tissue and plasma samples from patients with advanced non-small cell lung carcinoma. Clin Chim Acta. 2016 Jun 1;457:106-11. doi: 10.1016/j.cca.2016.04.003. Epub 2016 Apr 9.
- Background: PubMed 26993877Song Y, Zhou X, Huang S, Li X, Qi Q, Jiang Y, Liu Y, Ma C, Li Z, Xu M, Cram DS, Liu J. Quantitation of fetal DNA fraction in maternal plasma using circulating single molecule amplification and re-sequencing technology (cSMART). Clin Chim Acta. 2016 May 1;456:151-156. doi: 10.1016/j.cca.2016.03.005. Epub 2016 Mar 15.
- Background: PubMed 25376582Lv W, Wei X, Guo R, Liu Q, Zheng Y, Chang J, Bai T, Li H, Zhang J, Song Z, Cram DS, Liang D, Wu L. Noninvasive prenatal testing for Wilson disease by use of circulating single-molecule amplification and resequencing technology (cSMART). Clin Chem. 2015 Jan;61(1):172-81. doi: 10.1373/clinchem.2014.229328. Epub 2014 Nov 6.
- Individual participant dataSharing planned: No
Related trials for Nonsmall Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Shun Lu, MD/PhD study chair
Shanghai Chest Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonsmall Cell Lung Cancer and Adenocarcinoma, run by Berry Genomics Co., Ltd. at 9 sites 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 8 inclusion and 9 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 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
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?
The TKI resistance gene mutation pattern in plasma DNA of TKI treated patient (time frame: 1.5 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 NCT02980536, which also lists 4 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 11 Jul 2018.