Development of Circulating Tumour Cell Molecular Diagnostics Using a Novel Microfluidic Device

NCT01193829 | Unknown

• 1 other identifier: PK05/16/10
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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

Conditions

Patients With Non-small Cell Lung Cancer

Study Arms (1)

NSCLC patients

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital patients

You may qualify if:

• 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

You may not qualify if:

• Patients unwilling to provide consent
• Patients, who in the opinion of the investigator, are unable to comply with study requirements

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore, Singapore

RECRUITING

Related Publications (2)

• Tamura 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 BACKGROUND

• Sequist 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 BACKGROUND

Biospecimen

Blood will be collected for circulating tumor cells (CTC) using previously optimized methods described by Tan et al. DNA will be extracted from CTC and matching tumor samples (for aim 1) and tested for somatic lung mutations by direct sequencing (2). Germline DNA will be analysed for genes related to putative genetic risks for NSCLC and, for treatment toxicities, for genes related to gefitinib and other chemotherapy metabolic pathways.

Central Study Contacts

Ross Andrew Soo, MBBS

CONTACT

65-6772-4624; Ross_Soo@nuh.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 2, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

SG (1)