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

Primary Purpose

Colorectal Cancers

Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
microRNAs
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancers focused on measuring early diagnosis, prediction, prognosis

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kaohsiung Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

early recurrence

Arm Description

find the postoperative early relapse out

Outcomes

Primary Outcome Measures

postoperative early recurrence

Secondary Outcome Measures

Full Information

First Posted
January 27, 2013
Last Updated
April 10, 2013
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
Academia Sinica, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01828918
Brief Title
Biomarkers for the Early Diagnosis, Prediction, Prognosis for Colorectal Cancers
Official Title
Kaohsiung Medical University Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
Academia Sinica, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancers
Keywords
early diagnosis, prediction, prognosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
early recurrence
Arm Type
Other
Arm Description
find the postoperative early relapse out
Intervention Type
Genetic
Intervention Name(s)
microRNAs
Primary Outcome Measure Information:
Title
postoperative early recurrence
Time Frame
within 12 months postoperation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 y/o Histological / pathologic and image study proved colorectal cancer Patients with adequate tissue for biomarkers analysis Patients voluntary sign informed consent Exclusion Criteria: Patients who are not met with either one of items which mentioned above.
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaw-Yuan Wang, Professor
Phone
+886-7-3121101
Ext
5583
Email
cy614112@ms14.hinet.net
First Name & Middle Initial & Last Name & Degree
Jaw-Yuan Wang, Professor

12. IPD Sharing Statement

Learn more about this trial

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

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