Carcinoma, Non-Small-Cell LungNCT02804100
Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients
An observational study of Carcinoma, Non-Small-Cell Lung and Bronchial Neoplasms, run by Wenzhou Medical University at 1 site in China.
Trial summary
A multi-centre observational, non-interventional study is to dynamically monitor the changes of circulating tumor DNA (ctDNA) in late stage NSCLC patients under Gefitinib treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Bronchial Neoplasms, Carcinoma, Bronchogenic
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Jun 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: NSCLC patients with activating EGFR mutations
Who may be able to join
- Provision of informed consent
- Histologically confirmed stage IIIB/IV NSCLC.
- Activating EGFR mutations (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q)
- Able to comply with the required protocol and followed-up procedures, and able to receive oral medications
Who cannot join
- Histologically confirmed small cell lung cancer or other metastatic tumors
- Patient had received prior chemotherapy or EGFR-TKIs treatment
- Patients who harbor Exon20 T790M mutation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Ju Luan, PhD, luanluanjuju@163.com
Wenfeng Li, MD
About this study
Official title: A Multi-centre Observational Study on Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients Under Gefitinib Treatment
A multi-centre observational, non-interventional study is to dynamically monitor the changes of circulating tumor DNA (ctDNA) in late stage NSCLC patients under Gefitinib treatment.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Bronchial Neoplasms, Carcinoma, Bronchogenic, Lung Diseases, Lung Neoplasms
- Keywords
- Circulating Tumor DNA, Lung cancer, Plasma DNA
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Bronchial Neoplasms, Carcinoma, Bronchogenic, Lung Diseases, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
dynamic changes of circulating tumor DNA in late stage NSCLC patients under Gefitinib treatment
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 posted17 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (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 Carcinoma, Non-Small-Cell LungStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunming Ding, Wenzhou Medical University
- Investigators
- Wenfeng Li, Ph.D, Study chair, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804100
- Sponsor's protocol ID
- 4241616009G
- Status last verified
- Oct 2016
- First submitted
- 14 Jun 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Yang Z, Li J, Hu Y, Chen M, Peng D, Zong D, Shang Q, Tao L, Zhao Y, Ni Y, Ye J, Xie Y, Yang L, Lin Q, Cai C, Xu N, Huang X, Dong X, Zhou Z, Yu Y, Shangguan Z, Xu Y, Ying W, Weng M, Yuan Z, Dong Z, Li J, Zheng Z, Pan J, Liu L, Ye J, Zhang Z, Li W, Zhu J, Jin S, Li Y, Ding C. Dynamics of Plasma EGFR T790M Mutation in Advanced NSCLC: A Multicenter Study. Target Oncol. 2019 Dec;14(6):719-728. doi: 10.1007/s11523-019-00682-0.
PubMed 31691892
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Observational Study on Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients Under Gefitinib Treatment
- ClinicalTrials.gov ID
- NCT02804100
- Acronym / sponsor ID
- 4241616009G
- Conditions
- Carcinoma, Non-Small-Cell Lung, Bronchial Neoplasms, Carcinoma, Bronchogenic, Lung Diseases, Lung Neoplasms
- Keywords
- Circulating Tumor DNA, Lung cancer, Plasma DNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 17 Jun 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.
A multi-centre observational, non-interventional study is to dynamically monitor the changes of circulating tumor DNA (ctDNA) in late stage NSCLC patients under Gefitinib treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLC patients with activating EGFR mutations
Key inclusion criteria (4 listed)
- Provision of informed consent
- Histologically confirmed stage IIIB/IV NSCLC.
- Activating EGFR mutations (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q)
- Able to comply with the required protocol and followed-up procedures, and able to receive oral medications
Key exclusion criteria (3 listed)
- Histologically confirmed small cell lung cancer or other metastatic tumors
- Patient had received prior chemotherapy or EGFR-TKIs treatment
- Patients who harbor Exon20 T790M mutation
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
dynamic changes of circulating tumor DNA in late stage NSCLC patients under Gefitinib treatment
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 1 Nov 2016.
- Derived from this study: PubMed 31691892Yang Z, Li J, Hu Y, Chen M, Peng D, Zong D, Shang Q, Tao L, Zhao Y, Ni Y, Ye J, Xie Y, Yang L, Lin Q, Cai C, Xu N, Huang X, Dong X, Zhou Z, Yu Y, Shangguan Z, Xu Y, Ying W, Weng M, Yuan Z, Dong Z, Li J, Zheng Z, Pan J, Liu L, Ye J, Zhang Z, Li W, Zhu J, Jin S, Li Y, Ding C. Dynamics of Plasma EGFR T790M Mutation in Advanced NSCLC: A Multicenter Study. Target Oncol. 2019 Dec;14(6):719-728. doi: 10.1007/s11523-019-00682-0.
- 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.
Wenfeng Li, Ph.D study chair
First Affiliated Hospital of Wenzhou Medical 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 Carcinoma, Non-Small-Cell Lung and Bronchial Neoplasms, run by Wenzhou Medical University 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 4 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 1 Nov 2016. 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 Chunming Ding, Ph.D (86-755-86690871, cmdingchina@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dynamic changes of circulating tumor DNA in late stage NSCLC patients under Gefitinib treatment (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 NCT02804100, 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 1 Nov 2016.