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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer (CRC)

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

diagnosed colorectal cancer patient

Description

Inclusion Criteria:

• Clinical diagnosis of colorectal cancer

Exclusion Criteria:

• age younger than 20
• Pregnancy
• Inmates

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yu-Ting Chang, MD.PhD, Visting stuff of national taiwan university hospital; Study Chair: National Taiwan University NTUH, Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ANTICIPATED): January 1, 2019
• Study Completion (ANTICIPATED): January 1, 2019

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (ESTIMATE): December 9, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 9, 2013
• Last Update Submitted That Met QC Criteria: December 4, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Neoplasm Metastasis; Colorectal Neoplasms; Recurrence; Neoplastic Cells, Circulating
• Other Study ID Numbers: 201309068RINC