Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients

A Multi-centre Observational Study on Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients Under Gefitinib Treatment

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02804100

Enrollment

200

Registered

2016-06-17

Start date

2016-05-31

Completion date

2018-06-30

Last updated

2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Neoplasms, Carcinoma, Bronchogenic, Carcinoma, Non-Small-Cell Lung, Lung Diseases, Lung Neoplasms

Keywords

Circulating Tumor DNA, Lung cancer, Plasma DNA

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
dynamic changes of circulating tumor DNA in late stage NSCLC patients under Gefitinib treatment	2 years

Countries

China

Contacts

Primary ContactChunming Ding, Ph.D

cmdingchina@qq.com86-755-86690871

Backup ContactJu Luan, Ph.D

luanluanjuju@163.com86-755-86690871

Outcome results