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Trial record 75 of 6670 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

Screening of Hereditary Upper Gastrointestinal Cancer in China

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ClinicalTrials.gov Identifier: NCT03130621
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Peking University

Brief 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.

Condition or disease Intervention/treatment
Improve the Screening Criteria of Chinese Hereditary Upper Gastrointestinal Tumors Diagnostic Test: Gene detection

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Family-Based
Time Perspective: Retrospective
Official Title: Screening of Hereditary Upper Gastrointestinal Cancer in China
Actual Study Start Date : January 2017
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

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;
Diagnostic Test: Gene detection
Next-generation sequencing

Esophageal squamous cell carcinoma
Family History of Malignancy; Multiple primary malignant tumors; MSI or dMMR;
Diagnostic Test: Gene detection
Next-generation sequencing




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
  1. propositus:10ml venous blood for germline mutation detection; tumor biospy tissue for somatic mutation detection(optional)
  2. immediate relatives of propositus with Pathogenic mutation or likely-pathogenic mutation:10ml venous blood for germline mutation detection


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Upper Gastrointestinal Cancer
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130621


Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Shen Lin, Professor    010-88196561    Linshenpku@163.com   
Principal Investigator: Shen Lin, professor         
Sponsors and Collaborators
Peking University

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Responsible Party: Shen Lin, Chief physician, Peking University
ClinicalTrials.gov Identifier: NCT03130621     History of Changes
Other Study ID Numbers: CGOG1012
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases