- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03130621
Screening of Hereditary Upper Gastrointestinal Cancer in China
June 2, 2019 updated by: Shen Lin, Peking University
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with Upper Gastrointestinal Cancer
Description
Inclusion Criteria:
Patients with gastric cancer, esophageal adenocarcinoma, or duodenal adenocarcinoma meet one of the following criteria:
- age≤30;
- age≤35,gastric cancer with special pathological types;
- age≤50,≥one first-degree relative of a malignant tumor;
- ≥ two first-degree/second-degree relatives of a malignant tumor,and ≥one first-degree relative;
- have ≥two types of malignancies,and age ≤50 at the first time of diagnosis;
- MSI or dMMR of tissue specimen;
Patients with esophageal squamous cell carcinomas meet one of the following criteria:
- ≥ two first-degree/second-degree relatives of a malignant tumor,and ≥one first-degree relative;
- have ≥two types of malignancies,and age ≤50 at the first time of diagnosis;
- MSI or dMMR of tissue specimen;
Exclusion Criteria:
- Patients do not meet one of the inclusion criteria;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adenocarcinoma of upper digestive tract
Early-onset carcinomas ; Family History of Malignancy; Special pathological type; MSI or dMMR; Multiple primary malignant tumors;
|
Next-generation sequencing
|
Esophageal squamous cell carcinoma
Family History of Malignancy; Multiple primary malignant tumors; MSI or dMMR;
|
Next-generation sequencing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pedigree analysis
Time Frame: 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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
somatic mutation landscape of hereditary upper gastrointestinal cancer
Time Frame: We plan to accomplish sample collection, sequencing and data analysis before 2022.3
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Anticipated)
March 1, 2022
Study Completion (Anticipated)
March 1, 2022
Study Registration Dates
First Submitted
April 22, 2017
First Submitted That Met QC Criteria
April 22, 2017
First Posted (Actual)
April 26, 2017
Study Record Updates
Last Update Posted (Actual)
June 4, 2019
Last Update Submitted That Met QC Criteria
June 2, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGOG1012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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