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NCT03309462

Analysis of Re-biopsy Specimens in Advanced NSCLC With Acquired Resistance of EGFR-TKI Targeted Therapy

Completed NA Last updated 9 December 2019
What this trial tests

NA trial testing Miseq sequencer in Lung Cancer in 50 participants. Completed in 31 July 2019.

Timeline
1 September 2017
Primary endpoint
30 June 2018
31 July 2019

Quick facts

Lead sponsorShanghai Chest Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment50
Start date1 September 2017
Primary completion30 June 2018
Estimated completion31 July 2019
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai Chest Hospital

Who can join

Adults 18 to 80, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Clinical Utility of Liquid Biopsy-Based Actionable Mutations Detected via ddPCR.
    Palacín-Aliana I, García-Romero N, Asensi-Puig A, Carrión-Navarro J, et al · · 2021 · cited 38× · PMID 34440110 · DOI 10.3390/biomedicines9080906
  2. 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.
    Zhang Y, Xiong L, Xie F, Zheng X, et al · · 2021 · cited 13× · PMID 34173341 · DOI 10.1002/cam4.3948
  3. 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
    Zhang Y, Xiong L, Xie F, Zheng X, et al · · 2020 · DOI 10.21203/rs.3.rs-30958/v1

Verify or expand the search:

Other recruiting trials for Lung Cancer

Currently open trials in the same condition.

Other Shanghai Chest Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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