Biomarkers for the Early Diagnosis, Prediction, Prognosis for Colorectal Cancers

Colorectal Cancers Clinical Trial

Official title:

Kaohsiung Medical University Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01828918
• Other study ID #: KMUH-IRB-2012-03-02 (II)
• Status: Recruiting
• Phase: Phase 1
• First received: January 27, 2013
• Last updated: April 10, 2013
• Start date: June 2012
• Est. completion date: December 2016

Study information

• Verified date: June 2012
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Recent basic and clinical research on the circulating tumor cells (CTCs) in CRC patients takes potential diagnostics, prognostics, 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. CTCs measures may be useful to guide change in treatment decisions.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancers
• Colorectal Neoplasms

Intervention

Genetic:
• microRNAs

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	Academia Sinica, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative early recurrence		within 12 months postoperation	Yes