Stomach NeoplasmsRECORDNCT04574245
Gastric Cancer Liver Metastasis Cohort of China
An observational study of Stomach Neoplasms and Neoplasm Metastasis, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms, Neoplasm Metastasis
- What is being tested?
- Gastrectomy; Hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2010to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible in-hospital gastric cancer liver metastases cases.
Who may be able to join
- 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.
Who cannot join
- Poor compliance to treatment or lost to follow-up;
- Gross loss of clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site
General Surgery Institute, China PLA General Hospital
Beijing, Beijing Municipality, 100853
About this study
Official title: 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.
- Conditions
- Stomach Neoplasms, Neoplasm Metastasis
- Being tested
- Gastrectomy; Hepatectomy
- Keywords
- Prognosis, Multidisciplinary treatment, C-GCLM Classification, Gastric cancer, Liver metastasis
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrectomy; HepatectomyProcedure or surgery
Also called Radiofrequency ablation, Chemotherapy, Immunotherapy, Target therapy
| Study group | Role | What they receive |
|---|---|---|
| Resectable group | Not described Receives: Procedure: Gastrectomy; Hepatectomy | |
| Potentially resectable group | Not described | |
| Unresectable group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year overall survival
The proportion (%) of gastric cancer liver metastasis patients that survived beyond one-year follow-up period.
Measured: 2011/01/01-2020/12/31
3-year overall survival
The proportion (%) of gastric cancer liver metastasis patients that survived beyond three-year follow-up period.
Measured: 2011/01/01-2021/12/31
5-year overall survival
The proportion (%) of gastric cancer liver metastasis patients that survived beyond five-year follow-up period.
Measured: 2011/01/01-2021/12/31
Secondary outcomes (4)
The incidence of gastric cancer liver metastasis cases
The rate of gastric cancer liver metastasis cases divided by all gastric cancer cases in the study period.
Measured: 2010/01/01-2019/12/31
The proportion for synchronous and metachronous liver metastases cases
The proportion (%) of synchronous or metachronous gastric cancer liver metastases cases in all gastric cancer cases
Measured: 2010/01/01-2019/12/31
The survival of patients that recieved different therapeutic methods
The proportion (%) of patients under different therapies that survived beyond specific follow-up period.
Measured: 2010/01/01-2019/12/31
The prognostic predictive value for patients with different C-GCLM classification
The proportion (%) of patients of different classification that survived beyond specific follow-up period.
Measured: 2010/01/01-2019/12/31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Jan 2010
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chen, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574245
- Sponsor's protocol ID
- S2020-381
- Acronym
- RECORD
- Status last verified
- Oct 2022
- First submitted
- 23 Sep 2020
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32127925
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Multi-institutional Cohort Study of Gastric Cancer Liver Metastasis in Real-world Data of China
- ClinicalTrials.gov ID
- NCT04574245
- Acronym / sponsor ID
- RECORD / S2020-381
- Conditions
- Stomach Neoplasms, Neoplasm Metastasis
- Keywords
- Prognosis, Multidisciplinary treatment, C-GCLM Classification, Gastric cancer, Liver metastasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resectable group | – | Procedure: Gastrectomy; Hepatectomy |
| Potentially resectable group | – | – |
| Unresectable group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible in-hospital gastric cancer liver metastases cases.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Poor compliance to treatment or lost to follow-up;
- Gross loss of clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastrectomy; HepatectomyAlso: Radiofrequency ablation, Chemotherapy, Immunotherapy, Target therapy | Procedure or surgery | Resectable group |
Primary outcome
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.
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.
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.
4 secondary outcomes
The incidence of gastric cancer liver metastasis cases
Time frame: 2010/01/01-2019/12/31
The proportion for synchronous and metachronous liver metastases cases
Time frame: 2010/01/01-2019/12/31
The survival of patients that recieved different therapeutic methods
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Background: PubMed 32127925Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasms and Neoplasm Metastasis, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year overall survival (time frame: 2011/01/01-2020/12/31). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04574245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.