Clinical Validation of a Microfluidic Device for Isolatio... | NCT01022723

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

NCT01022723

Sponsor

National Cancer Centre, Singapore

Status

Unknown status

Last Update Posted

Sep 14, 2018Actual

Enrollment

817Estimated

Phase

Not provided

Conditions

Cancer

Interventions

Not provided

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Nov 30, 2009

First Submission Date that Met QC Criteria

Nov 30, 2009

First Posted Date

Dec 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2018

Last Update Posted Date

Sep 14, 2018Actual

Name	Class
National Medical Research Council (NMRC), Singapore	OTHER_GOV
National University of Singapore	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

817Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lung Cancer patients		Lung Cancer (particular focus on non smokers with adenocarcinoma)
Patients with Nasopharyneal carcinoma		Patients with Nasopharyneal carcinoma
Breast Cancer patients		Breast cancer patients
Prostate Cancer patients		Prostate cancer patients
Colorectal Cancer patients		Colorectal cancer patients
Gastric Cancer patients		Gastric cancer patients

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with the following cancers:

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lanying Wang, Primary	Contact	+6564368267		nctwly@nccs.com.sg

Overall Officials

Name	Affiliation	Role
Wan-Teck Lim, MD	National Cancer Centre, Singapore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Centre	Recruiting	Singapore			Singapore

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D009360	Neoplastic Cells, Circulating
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided