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

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.
 
ClinicalTrials.gov Identifier: NCT01828918
Recruitment Status : Unknown
Verified June 2012 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
Sponsor:
Collaborator:
Academia Sinica, Taiwan
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancers Genetic: microRNAs Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Kaohsiung Medical University Hospital
Study Start Date : June 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
early recurrence
find the postoperative early relapse out
Genetic: microRNAs



Primary Outcome Measures :
  1. postoperative early recurrence [ Time Frame: within 12 months postoperation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT01828918


Locations
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Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Jaw-Yuan Wang, Professor    +886-7-3121101 ext 5583    cy614112@ms14.hinet.net   
Principal Investigator: Jaw-Yuan Wang, Professor         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Academia Sinica, Taiwan
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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01828918    
Other Study ID Numbers: KMUH-IRB-2012-03-02 (II)
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: June 2012
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
early diagnosis
prediction
prognosis
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases