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

September 12, 2018 updated by: National Cancer Centre, Singapore
To evaluate the efficiency of a microdevice for circulating tumor cells isolation and to correlate the circulating titre with response and progression.

Study Overview

Status

Unknown

Conditions

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

Study Type

Observational

Enrollment (Anticipated)

817

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National Cancer Centre
        • Principal Investigator:
          • Lim W Teck, Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with the following cancers:

Lung Cancer Nasopharyneal carcinoma Breast cancer Prostate cancer Colorectal cancer Gastric cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast Cancer patients
Breast cancer patients
Lung Cancer patients
Lung Cancer (particular focus on non smokers with adenocarcinoma)
Patients with Nasopharyneal carcinoma
Prostate Cancer patients
Prostate cancer patients
Colorectal Cancer patients
Colorectal cancer patients
Gastric Cancer patients
Gastric cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 3 years
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Collaborators

National Medical Research Council (NMRC), Singapore
National University of Singapore

Investigators

  • Principal Investigator: Wan-Teck Lim, MD, National Cancer Centre, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (Estimate)

December 1, 2009

Study Record Updates

Last Update Posted (Actual)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC_ver2_081109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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