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

NCT ID: NCT01022723

Last Updated: 2018-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

817 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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* 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

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lung Cancer patients

Lung Cancer (particular focus on non smokers with adenocarcinoma)

No interventions assigned to this group

Patients with Nasopharyneal carcinoma

Patients with Nasopharyneal carcinoma

No interventions assigned to this group

Breast Cancer patients

Breast cancer patients

No interventions assigned to this group

Prostate Cancer patients

Prostate cancer patients

No interventions assigned to this group

Colorectal Cancer patients

Colorectal cancer patients

No interventions assigned to this group

Gastric Cancer patients

Gastric cancer patients

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Medical Research Council (NMRC), Singapore

OTHER_GOV

Sponsor Role collaborator

National University of Singapore

OTHER

Sponsor Role collaborator

National Cancer Centre, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wan-Teck Lim, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Centre, Singapore

Locations

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National Cancer Centre

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Lanying Wang, Primary

Role: CONTACT

+6564368267

Other Identifiers

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CTC_ver2_081109

Identifier Type: -

Identifier Source: org_study_id

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