- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03365986
Systemic Screening for Hereditary Colorectal Cancer in China
Systemic Screening of Germline Cancer Gene Mutation for Colorectal Cancer in China: A Prospective and Multi-center Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hereditary factors play a very important role in colorectal cancer risk. Identification of the germline cancer gene mutation at the time of colorectal cancer presentation has significant implications for the patients and families, as it directs follow up and clinical options. Professional guidelines recommend patients with colorectal cancer receive a phenotype-driven genetic testing strategies. For example,Lynch syndrome was identified in 2%-4% of patients with CRC using micro-satellite instability (MSI) or DNA mismatch repair (MMR) protein immunohistochemistry (IHC) tumor testing in preselected patients for germline MMR gene testing. However, there is few of clinical characteristics or germline gene mutation data from Chinese population. With the advent of next-generation sequencing (NGS), genetic testing for hereditary CRC has shifted from phenotype-specific single gene assessment to broad panels providing simultaneous assessment of multiple genes implicated in various hereditary cancer syndromes. This study plans to screen and establish a database of 500 consecutive newly diagnosed patients with CRC using multigene panel testing based on Next-Generation Sequencing. The purpose of this study is to:
- Determine the prevalence of hereditary colorectal cancer and spectrum of germline cancer gene mutation among Chinese population.
- Evaluate the cost-effectiveness and optimize the design of multigene panel testing.
- Establish a statewide screening model for hereditary colorectal cancer.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ding Peirong, MD
- Phone Number: 8602087343920
- Email: dingpr@sysucc.org.cn
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- 651 Dongfeng Road East
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Contact:
- Wu Jiang, Doctor
- Phone Number: +86 15989120166
- Email: jiangwu@sysucc.org.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Newly diagnosed with colorectal adenocarcinoma (all stages) patients. For individuals who are old than 70 years old should meet the revised Bethesda Guidelines or polyposis syndromes testing criteria.
- Agree to provide related information.
Exclusion Criteria:
- Individuals who are under the age of 18.
- Individuals who refuse to test.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of hereditary colorectal cancer
Time Frame: 3 months
|
Through genetic testing for germline cancer susceptibility gene mutations among 500 consecutive patients with colorectal cancer using multigene panel testing based on Next-Generation Sequencing
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cost-effect for hereditary colorectal cancer screening
Time Frame: 3 months
|
The direct cost of multigene panel testing or the traditional phenotype-specific single gene testing for hereditary colorectal cancer were estimated, and cost-effect analysis were be done between this two strategies
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ding Peirong, MD, Sun Yat-sen University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-FXY-075
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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