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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01022723
Other study ID # CTC_ver2_081109
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2009
Est. completion date December 2018

Study information

Verified date September 2018
Source National Cancer Centre, Singapore
Contact Lanying Wang, Primary
Phone +6564368267
Email nctwly@nccs.com.sg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 817
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Singapore National Cancer Centre Singapore

Sponsors (3)

Lead Sponsor Collaborator
National Cancer Centre, Singapore National Medical Research Council (NMRC), Singapore, National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

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