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Kaohsiung Medical University Hospital

Phase 1
20 Years
90 Years
Open (Enrolling)
Colorectal Cancers

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Trial Information

Kaohsiung Medical University Hospital

Colorectal cancer (CRC) is one of the most frequent malignancies and is also the third major
cause of cancer-related death in Taiwan, with over 11,000 new cases of CRC were diagnosed
and more than 4,400 Taiwanese died from CRC in 2008 (Department of Health). CRC is regarded
as the accumulation of acquired genetic and epigenetic changes causing disorders in cell
growth, differentiation and apoptosis resulting in transformation of normal colonic
epithelium to colon adenocarcinoma.

Recent basic and clinical research on the circulating tumor cells (CTCs) in CRC patients
takes potential diagnostics, prognosis, and applications into consideration, especially the
molecular detection of CTCs in peripheral blood. Moreover, identification of therapeutic
targets on CTCs and real-time monitoring of CTCs in cancer patients undergoing systemic
therapy are the most important future clinical applications. The investigators divide the
current project into three dimensions to include all the biomarkers related to diagnostic,
prognostic and predictive roles for the potential clinical implication. Sub-project 1:
prognostic validation and economic evaluation of biochips/biomarkers. Sub-project 2:
evaluation of biomarkers for tailored therapy. Sub-project 3: identification and validation
of novel biomarkers for early detection. After accomplishment of three sub-projects, a
comprehensive network including early diagnostic, prognostic and predictive
biomarkers/biochips for high-risk screening, postoperative surveillance, therapeutic
strategies of CRC patients will be formed.

Inclusion Criteria:

1. Age > 18 y/o

2. Histological / pathologic and image study proved colorectal cancer

3. Patients with adequate tissue for biomarkers analysis

4. Patients voluntary sign informed consent

Exclusion Criteria:

- Patients who are not met with either one of items which mentioned above.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

postoperative early recurrence

Outcome Time Frame:

within 12 months postoperation

Safety Issue:



Taiwan: Institutional Review Board

Study ID:

KMUH-IRB-2012-03-02 (II)



Start Date:

June 2012

Completion Date:

December 2016

Related Keywords:

  • Colorectal Cancers
  • early diagnosis
  • prediction
  • prognosis
  • Colorectal Neoplasms