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

NCT01022723 | Unknown DMC

• 1 other identifier: CTC_ver2_081109
• Study Type: observational
• Target: 817
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• 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

Study Arms (6)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with the following cancers: Lung Cancer Nasopharyneal carcinoma Breast cancer Prostate cancer Colorectal cancer Gastric cancer

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• National Medical Research Council (NMRC), Singapore: collaborator
• National University of Singapore: collaborator

Study Sites (1)

National Cancer Centre

Singapore, Singapore

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Circulating Tumor Cells

MeSH Terms

Conditions

Neoplasms; Neoplastic Cells, Circulating; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wan-Teck Lim, MD

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lanying Wang, Primary

CONTACT

+6564368267; nctwly@nccs.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 1, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 14, 2018

Record last verified: 2018-09

Locations

SG (1)