Systemic Screening for Hereditary Colorectal Cancer in China

NCT03365986 | Unknown

• 1 other identifier: 2017-FXY-075
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the this study is to determine the prevalence of germline cancer susceptibility gene mutation among Chinese population, and to find best ways to screen patients with colorectal cancer in China. To accomplish this objective, the investigators will establish a large sample database of hereditary colorectal cancer related information using multigene panel testing based on Next-Generation Sequencing.

Conditions

Hereditary Colorectal Cancer

Keywords

hereditary; colorectal cancer; screening

Outcome Measures

Primary Outcomes (1)

• The incidence of hereditary colorectal cancer

  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

  3 months

Secondary Outcomes (1)

• cost-effect for hereditary colorectal cancer screening

  3 months

Interventions

genetic screening DIAGNOSTIC_TEST

Patients receive genetic test to see whether they have germline cancer susceptibility gene mutations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed patients with colorectal adenocarcinoma (all stages). For individuals who are old than 70 years old should meet the revised Bethesda Guidelines or polyposis syndromes testing criteria.

You may qualify if:

• 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.

You may not qualify if:

• Individuals who are under the age of 18.
• Individuals who refuse to test.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

651 Dongfeng Road East

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (1)

• Jiang W, Li L, Ke CF, Wang W, Xiao BY, Kong LH, Tang JH, Li Y, Wu XD, Hu Y, Guo WH, Wang SZ, Wan DS, Xu RH, Pan ZZ, Ding PR. Universal germline testing among patients with colorectal cancer: clinical actionability and optimised panel. J Med Genet. 2022 Apr;59(4):370-376. doi: 10.1136/jmedgenet-2020-107230. Epub 2021 Feb 9.

  PMID: 33563768 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood retained, DNA was extracted for sequencing

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Ding Peirong, MD

  Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Ding Peirong, MD

CONTACT

8602087343920; dingpr@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 26, 2017
• First Posted: December 8, 2017
• Study Start: January 1, 2018
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: December 12, 2017

Record last verified: 2017-12

Locations

CN (1)