NCT03309462

Brief Summary

The objective of the study is to reveal the acquired resistance mechanism of the first and second generation Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) in tissue and plasma using Next Generation Sequencing (NGS) and the difference of ctDNA in plasma and DNA in biopsy samples is compared and the consistency of two samples was observed. At the same time, the sensitivity, specificity and the consistency of detecting T790M mutation using ddPCR, Cobas and NGS were compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

October 10, 2017

Last Update Submit

December 6, 2019

Conditions

Lung Cancer

Keywords

Next generation sequencingRe-biopsyAcquired resistanceTissue samplePeripheral blood

Outcome Measures

Primary Outcomes (1)

  • Compare the differences of gene mutation between tissue sample and peripheral blood sample by NGS

    differences of gene mutation between re-biopsy tissue sample and peripheral blood sample will be tested by NGS

    up to one year

Study Arms (2)

Re-biopsy tissue sample

EXPERIMENTAL

The gene testing of re-biopsy tissue sample diagnosed with NSCLC will be performed with NGS using Illumina Miseq squencer and Cobas.

Device: Miseq sequencer

Peripheral blood sample

EXPERIMENTAL

The peripheral blood sample will be extracted with DNA and performed with NGS using Illumina Miseq squencer and ddPCR.

Device: Miseq sequencer

Interventions

Miseq sequencerDEVICE

The sequencer will be used to detect the gene mutations of the re-biopsy tissue samples and peripheral blood samples obtained from patients.

Peripheral blood sampleRe-biopsy tissue sample

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • EGFR mutations were confirmed by molecular pathology.
  • Patients who were treated by the first and the second generation EGFR-TKI.
  • Patients were evaluated PD according to RECIST imaging standard.
  • Patients with functional status score (Performance Status, PS) for 0-2 points according to the Eastern Cooperative Oncology Group (ECOG) .
  • Patients can receive histological / cytological specimens through microsurgical biopsy techniques, including but not limited to transbronchial biopsy (TBB), transbronchial lung biopsy (TBLB), transabonchial needle aspiration (TBNA), CT / ultrasound guided thoracic needle aspiration biopsy (CT / ultrasound guided-TTNA), ultrasound-guided superficial lymph node biopsy.

You may not qualify if:

  • Patients received blood transfusion within 1 month.
  • Patients suffering from autoimmune diseases, including but not limited to systemic lupus erythematosus, class of wet arthritis, Sjogren's syndrome.
  • Patients with severe disease is not suitable for medical biopsy.
  • Patients refused to participate in clinical trials.
  • Researchers consider that the patient is not suitable for participating in this clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (1)

  • Zhang Y, Xiong L, Xie F, Zheng X, Li Y, Zhu L, Sun J. Next-generation sequencing of tissue and circulating tumor DNA: Resistance mechanisms to EGFR targeted therapy in a cohort of patients with advanced non-small cell lung cancer. Cancer Med. 2021 Jul;10(14):4697-4709. doi: 10.1002/cam4.3948. Epub 2021 Jun 25.

    PMID: 34173341DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jiayuan Sun, MD, PhD

    Shanghai Chest Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Endoscope Department, Shanghai Chest Hospital

Study Record Dates

First Submitted

October 10, 2017

First Posted

October 13, 2017

Study Start

September 1, 2017

Primary Completion

June 30, 2018

Study Completion

July 31, 2019

Last Updated

December 9, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)