RECORD: Gastric Cancer Liver Metastasis Cohort of China

• Sponsor: Chinese PLA General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04574245
• Collaborator: (none)
• Enrollment: 3,000
• Location: 1
• Anticipated Duration (Months): 144
• Patients Per Site Per Month: 20.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms; Neoplasm Metastasis	Procedure: Gastrectomy; Hepatectomy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 3000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrospective Multi-institutional Cohort Study of Gastric Cancer Liver Metastasis in Real-world Data of China
• Actual Study Start Date: Jan 1, 2010
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Resectable group	Procedure: Gastrectomy; Hepatectomy; Other Names: Radiofrequency ablation Chemotherapy Immunotherapy Target therapy
Potentially resectable group
Unresectable group

Outcome Measures

Primary Outcome Measures

1. 1-year overall survival [2011/01/01-2020/12/31]

   The proportion (%) of gastric cancer liver metastasis patients that survived beyond one-year follow-up period.

2. 3-year overall survival [2011/01/01-2021/12/31]

   The proportion (%) of gastric cancer liver metastasis patients that survived beyond three-year follow-up period.

3. 5-year overall survival [2011/01/01-2021/12/31]

   The proportion (%) of gastric cancer liver metastasis patients that survived beyond five-year follow-up period.

Secondary Outcome Measures

1. The incidence of gastric cancer liver metastasis cases [2010/01/01-2019/12/31]

   The rate of gastric cancer liver metastasis cases divided by all gastric cancer cases in the study period.

2. The proportion for synchronous and metachronous liver metastases cases [2010/01/01-2019/12/31]

   The proportion (%) of synchronous or metachronous gastric cancer liver metastases cases in all gastric cancer cases

3. The survival of patients that recieved different therapeutic methods [2010/01/01-2019/12/31]

   The proportion (%) of patients under different therapies that survived beyond specific follow-up period.

4. The prognostic predictive value for patients with different C-GCLM classification [2010/01/01-2019/12/31]

   The proportion (%) of patients of different classification that survived beyond specific follow-up period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Surgery Institute, China PLA General Hospital	Beijing	Beijing	China	100853

Sponsors and Collaborators

• Chinese PLA General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Zhang K, Chen L. Chinese consensus on the diagnosis and treatment of gastric cancer with liver metastases. Ther Adv Med Oncol. 2020 Feb 20;12:1758835920904803. doi: 10.1177/1758835920904803. eCollection 2020.

• Responsible Party: Lin Chen, Prof., Chinese PLA General Hospital
• ClinicalTrials.gov Identifier: NCT04574245
• Other Study ID Numbers: S2020-381
• First Posted: Oct 5, 2020
• Last Update Posted: Oct 5, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lin Chen, Prof., Chinese PLA General Hospital: Prognosis; Multidisciplinary treatment; C-GCLM Classification; Gastric cancer; Liver metastasis
• Additional relevant MeSH terms: Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary; Stomach Neoplasms

Study Results

No Results Posted as of Oct 5, 2020