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A Novel Patent Platform of Detection of Circulating Tumor Cells to Early Detect Colorectal Cancer Recurrence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02005913
Recruitment Status : Unknown
Verified December 2013 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 9, 2013
Last Update Posted : December 9, 2013
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

The best strategy to prevent colorectal cancer (CRC) death lies in early detection and early treatment at the local disease status of tumor. After curative resection of tumor, there are about 5~10% of stage I, 20~30% of stage II and 40~50% of stage III patients suffering metastasis during subsequent follow-up periods. Although carcinoembryonic antigen (CEA) is the most widely used biomarker for postoperative monitoring of recurrence on asymptomatic patients, it is difficult to use CEA as biological marker to identify the population with high recurrent risk in patients with early-stage cancer because lower than half of patients with early-stage cancer do not have CEA elevation. For improving the survival of patients with early-stage CRC, we need effort to search more useful biological markers to predict the risk of tumor recurrence and to select out patients with high recurrent risk to receive preventive adjuvant therapy.

Circulating tumor cells (CTCs) in the blood play an essential role in cancer metastasis. Hence, the detection of CTCs and subsequent analysis can potentially revolutionize the cancer care ranging from screening, diagnosis, monitoring, to drug selection and so on. In the past decade, many methods using magnetic beads (CellSearch), filtration (RareCelletc), or flow cytometry have been developed but all of them have the shortcomings from low sensitivity, low purity, to unable to retrieve cells for downstream molecular analysis and cell culture. Recently, a biomimetic affinity based microfluidic platform has overcome abovementioned technical challenges. Importantly, by using only 2 ml of peripheral blood, Sinica's team has shown that the enumeration of CTCs increases with the CRC disease progression, where the mean CTC counts are 3, 15, 29 and 60 per ml for the stages I, II, III and IV, respectively. The results imply that monitoring CTC enumeration serially may serve as a prediction marker to identify the CRC patients with high probability of recurrence. The aims of this study are toestablishing CTC platform standard operation protocol (SOP) that leads to certification of ISO 13485 and to establish CTC criteria and evaluate its prediction power of early detection of colorectal cancer recurrence.

Condition or disease
Colorectal Cancer (CRC)

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Novel Patent Platform of Detection of Circulating Tumor Cells to Early Detect Colorectal Cancer Recurrence
Study Start Date : January 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. tumor recurrence [ Time Frame: 1, 3, 6, 9 and 12 months post-surgery and 2 and 3 years after surgery as part of follow-up. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
diagnosed colorectal cancer patient

Inclusion Criteria:

  • Clinical diagnosis of colorectal cancer

Exclusion Criteria:

  • age younger than 20
  • Pregnancy
  • Inmates

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02005913

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Contact: chunhung kuo, master +886-23123456 ext 65768

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National Taiwan University Hospital
Taipei, Taiwan, 100
Contact: Yu-Ting Chang, MD,PhD    +886-2-23123456 ext 65768   
Principal Investigator: Yu-Ting Chang, MD,PhD         
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Yu-Ting Chang, MD.PhD Visting stuff of national taiwan university hospital
Study Chair: National Taiwan University NTUH Hospital
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Responsible Party: National Taiwan University Hospital Identifier: NCT02005913    
Other Study ID Numbers: 201309068RINC
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplastic Cells, Circulating
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes
Neoplasm Metastasis
Neoplastic Processes