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NCT03309462
Analysis of Re-biopsy Specimens in Advanced NSCLC With Acquired Resistance of EGFR-TKI Targeted Therapy
NA trial testing Miseq sequencer in Lung Cancer in 50 participants. Completed in 31 July 2019.
30 June 2018
Quick facts
| Lead sponsor | Shanghai Chest Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 50 |
| Start date | 1 September 2017 |
| Primary completion | 30 June 2018 |
| Estimated completion | 31 July 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- Miseq sequencer
Conditions studied
- Lung Cancer — all drugs for Lung Cancer →
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):
-
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 -
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 -
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:
- PubMed search for NCT03309462
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03309462 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Chest Hospital
- Last refreshed: 9 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03309462.
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