Clinical trial · Observational
Development of Circulating Tumour Cell Molecular Diagnostics Using a Novel Microfluidic Device
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
1. To compare EGFR mutations between primary non-small cell lung cancer (NSCLC) tumours and corresponding CTCs isolated by a label-free microfluidic device-based system 2. To characterize the association between clinical response in NSCLC patients treated with gefitinib and serial changes in CTC EGFR mutations detected by a label-free microfluidic device-based system The investigators recently developed a label-free, microfluidic device for capturing circulating tumour cells (CTCs) and acquired a Fluidigm Biomark digital PCR instrument for reliable low-level DNA quantification. The overall aim of this study is to test the feasibility of using these state-of-the-art devices to reliably detect clinically relevant EGFR mutations in CTCs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients With Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- NSCLC patients
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * For aim 1: * Patients with newly diagnosed non-small cell lung cancer who have not received any systemic therapy such as chemotherapy or targeted therapy. * Age 21 years or above * For aim 2 * Patients with a diagnosis of non small cell lung cancer * Receiving gefitinib as part of their treatment for NSCLC * Age 21 years or above Exclusion Criteria: * Patients unwilling to provide consent * Patients, who in the opinion of the investigator, are unable to comply with study requirements
References
Publications (2)
- BACKGROUNDTamura K, Okamoto I, Kashii T, Negoro S, Hirashima T, Kudoh S, Ichinose Y, Ebi N, Shibata K, Nishimura T, Katakami N, Sawa T, Shimizu E, Fukuoka J, Satoh T, Fukuoka M; West Japan Thoracic Oncology Group. Multicentre prospective phase II trial of gefitinib for advanced non-small cell lung cancer with epidermal growth factor receptor mutations: results of the West Japan Thoracic Oncology Group trial (WJTOG0403). Br J Cancer. 2008 Mar 11;98(5):907-14. doi: 10.1038/sj.bjc.6604249. Epub 2008 Feb 19. PMID 18283321
- BACKGROUNDSequist LV, Martins RG, Spigel D, Grunberg SM, Spira A, Janne PA, Joshi VA, McCollum D, Evans TL, Muzikansky A, Kuhlmann GL, Han M, Goldberg JS, Settleman J, Iafrate AJ, Engelman JA, Haber DA, Johnson BE, Lynch TJ. First-line gefitinib in patients with advanced non-small-cell lung cancer harboring somatic EGFR mutations. J Clin Oncol. 2008 May 20;26(15):2442-9. doi: 10.1200/JCO.2007.14.8494. Epub 2008 May 5. PMID 18458038