Gastric Cancer Liver Metastasis Cohort of China (RECORD)

October 3, 2022 updated by: Lin Chen, Chinese PLA General Hospital

Retrospective Multi-institutional Cohort Study of Gastric Cancer Liver Metastasis in Real-world Data of China

This multi-institutional retrospective cohort study aimed to describe and analyze the overall clinical characteristics, therapeutic status and prognosis pattern of gastric cancer liver metastasis (GCLM) in China.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

3000

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • General Surgery Institute, China PLA General 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All eligible in-hospital gastric cancer liver metastases cases.

Description

Inclusion Criteria:

  • Gastric cancer liver metastases cases aged over 18 years old;
  • Primary gastric carcinoma (including different histopathological types) confirmed by biopsy or surgery (pre-, intra- or post- treatment);
  • In hospital cases between 2020/01/01 to 2019/12/3.

Exclusion Criteria:

  • Poor compliance to treatment or lost to follow-up;
  • Gross loss of clinical data.

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
Resectable group
Procedure: Gastrectomy; Hepatectomy
Other Names:
  • Chemotherapy
  • Immunotherapy
  • Radiofrequency ablation
  • Target therapy
Potentially resectable group
Unresectable group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year overall survival
Time Frame: 2011/01/01-2020/12/31
The proportion (%) of gastric cancer liver metastasis patients that survived beyond one-year follow-up period.
2011/01/01-2020/12/31
3-year overall survival
Time Frame: 2011/01/01-2021/12/31
The proportion (%) of gastric cancer liver metastasis patients that survived beyond three-year follow-up period.
2011/01/01-2021/12/31
5-year overall survival
Time Frame: 2011/01/01-2021/12/31
The proportion (%) of gastric cancer liver metastasis patients that survived beyond five-year follow-up period.
2011/01/01-2021/12/31

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of gastric cancer liver metastasis cases
Time Frame: 2010/01/01-2019/12/31
The rate of gastric cancer liver metastasis cases divided by all gastric cancer cases in the study period.
2010/01/01-2019/12/31
The proportion for synchronous and metachronous liver metastases cases
Time Frame: 2010/01/01-2019/12/31
The proportion (%) of synchronous or metachronous gastric cancer liver metastases cases in all gastric cancer cases
2010/01/01-2019/12/31
The survival of patients that recieved different therapeutic methods
Time Frame: 2010/01/01-2019/12/31
The proportion (%) of patients under different therapies that survived beyond specific follow-up period.
2010/01/01-2019/12/31
The prognostic predictive value for patients with different C-GCLM classification
Time Frame: 2010/01/01-2019/12/31
The proportion (%) of patients of different classification that survived beyond specific follow-up period.
2010/01/01-2019/12/31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2010

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

October 5, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2020-381

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

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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