Screening of Hereditary Upper Gastrointestinal Cancer in China

Improve the Screening Criteria of Chinese Hereditary Upper Gastrointestinal Tumors Clinical Trial

Official title:

Screening of Hereditary Upper Gastrointestinal Cancer in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03130621
• Other study ID #: CGOG1012
• Status: Recruiting
• Start date: January 2017
• Est. completion date: March 2022

Study information

• Verified date: June 2019
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Through exploring the specific genetic mutations in the upper gastrointestinal tract tumors with a family history and specific clinical pathological types，we establish a complete family and follow-up system，in order to improve the screening criteria of Chinese hereditary upper gastrointestinal tumors and carry on primary prevention of disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients with gastric cancer, esophageal adenocarcinoma, or duodenal adenocarcinoma meet one of the following criteria:

1. age=30;

2. age=35,gastric cancer with special pathological types;

3. age=50,=one first-degree relative of a malignant tumor;

4. = two first-degree/second-degree relatives of a malignant tumor,and =one first-degree relative;

5. have =two types of malignancies,and age =50 at the first time of diagnosis;

6. MSI or dMMR of tissue specimen;

Patients with esophageal squamous cell carcinomas meet one of the following criteria:

1. = two first-degree/second-degree relatives of a malignant tumor,and =one first-degree relative;

2. have =two types of malignancies,and age =50 at the first time of diagnosis;

3. MSI or dMMR of tissue specimen;

Exclusion Criteria:

• Patients do not meet one of the inclusion criteria;

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Improve the Screening Criteria of Chinese Hereditary Upper Gastrointestinal Tumors

Intervention

Diagnostic Test:
• Gene detection
Next-generation sequencing

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pedigree analysis	We plan to analyse the families of patients who met the inclusion criterias through gene detection.	In the first phase of the project, we plan to detect 40-50 families in one year. And in the second phase,we will increase the number of predigree to 200. We hope to finish the phase before 2022.3
Secondary	somatic mutation landscape of hereditary upper gastrointestinal cancer	By comparing the landscape of somatic mutation of patients with different pathogenic germiline mutation , we want to explore the pathogenesis and molecule mechanism of hereditary upper digestive tract tumors.	We plan to accomplish sample collection, sequencing and data analysis before 2022.3