Clinical Validation of a Microfluidic Device for Isolation and Molecular Characterization of Circulating Tumor Cells

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01022723

Acronym

CTC

Enrollment

817

Registered

2009-12-01

Start date

2009-10-31

Completion date

2018-12-31

Last updated

2018-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Circulating tumor cells, metastasis, cancer, cell isolation, mircofludics, cell detection

Brief summary

To evaluate the efficiency of a microdevice for circulating tumor cells isolation and to correlate the circulating titre with response and progression.

Detailed description

* Validate the clinical use of a mircofluidic device to capture circulating timor cells from a broad range of tumor types * Characterize and identify these circulating tumor cells and demostrate cell viability with this capture method * Apply this technology in clinically relevant settings and correlate to response to treatment and disease progression * Elucidate predictive and pharmacodynamic biomarkers in the context of early phase trials of novel therapeutics

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with newly diagnosed metastatic disease planned for palliative chemotherapy * Tumor types as specified: non smokers with lung adenocarcinoma, undifferentiated EBV-ISH positive nasopharyneal carcinoma, breast cancer, colorectal cancer, prostate cancer, gastric cancer * Informed consent given for the purposes of blood sampling for this study * Measurable disease by RECIST criteria of at least 1cm is preferred but not a sine qua non for study accrual

Exclusion criteria

* N/A

Design outcomes

Primary

Measure	Time frame
The validation of the clinical use of a microfluidic device to capture circulating tumor cells (CTC) from a broad range of tumor types	3 years

Secondary

Measure	Time frame
Characteristics and viability of the CTC with this capture method	3 years
Clinical application of this capture method with the study of CTC titre correlation to treatment outcome	6 years
Study of predictive and pharmacodynamic biomarkers of the CTC in the context of early phase trials of novel therapeutics	6 years

Countries

Singapore

Contacts

Primary ContactLanying Wang, Primary

nctwly@nccs.com.sg+6564368267

Outcome results