Gastric CancerNCT06697821
The Number of Mesogastria Containing Metastatic Lymph Nodes Predicts Gastric Cancer Prognosis
An observational study of Gastric Cancer, run by Jichao Qin at 1 site in China.
Trial summary
To investigate the impact of the number of mesogastria containing metastatic lymph nodes on the prognosis of gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- D2＋CME
- Type of treatment
- Surgery or procedure
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 1 May 2024
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with gastric cancer who underwent total or proximal gastrectomy in Tongji Hospital were included in this study
Who may be able to join
- older than 18, younger than 85
- primary gastric adenocarcinoma confirmed by preoperative pathology
- routine blood tests, liver and kidney functions and who health status score are within the range of tolerable surgery
- it is expected to perform radical gastrectomy through d2+cme
Who cannot join
- pregnant or lactating women
- severe mental disorder or language communication disorder
- preoperative imaging examination or intraoperative exploration found that the patient had the following conditions: tumor involving surrounding organs requiring combined organ resection, distant organ metastasis or R0 resection could not be achieved
- those who are not suitable for laparoscopic surgery (such as extensive adhesion caused by anterior abdominal surgery and pneumoperitoneum for various reasons).
- concurrent malignancies at other sites
- emergency surgery patients
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
To investigate the impact of the number of mesogastria containing metastatic lymph nodes on the prognosis of gastric cancer.
Read the detailed description
Previous studies have established the existence of the mesogastrium, dividing it into six sections. The mesogastrium is identified during surgery and utilized in surgical practice. The aim of the present study was to further investigate its role in gastric cancer prognosis.Between January 2014 and January 2018, patients from the Tongji Hospital were included in this post-hoc analysis, including data from a randomized clinical study (DCGC01; http://www.clinicaltrials.gov, NCT01978444). Mesogastria containing metastatic lymph nodes (LNs) were referred to as metastatic mesogastria. Pathology reports were examined to assess metastases in the mesogastrium. Survival was assessed using Kaplan-Meier curves and multivariable Cox models.
- Conditions
- Gastric Cancer
- Being tested
- D2＋CME
- Keywords
- metastasis, Gastric Cancer, Lymph node, Mesogastrium
- 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.
D2＋CMEProcedure or surgery
Whether to perform the whole mesogastric excision
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Postoperative 5-year survival
Measured: Postoperative 5-year survival
Secondary outcomes (1)
The Number of Mesogastria Containing Metastatic Lymph Nodes
The Number of Mesogastria Containing Metastatic Lymph Nodes
Measured: Postoperative 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 May 2020
- Primary completion1 May 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jichao Qin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jichao Qin, Tongji Hospital
- Investigators
- Jichao Qin, M.D./Ph.D, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697821
- Sponsor's protocol ID
- TJ-IRB202403050
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Number of Mesogastria Containing Metastatic Lymph Nodes Predicts Gastric Cancer Prognosis
- ClinicalTrials.gov ID
- NCT06697821
- Acronym / sponsor ID
- TJ-IRB202403050
- Conditions
- Gastric Cancer
- Keywords
- metastasis, Gastric Cancer, Lymph node, Mesogastrium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Jichao QinUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 20 Nov 2024 (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.
To investigate the impact of the number of mesogastria containing metastatic lymph nodes on the prognosis of gastric cancer.
Detailed description
Previous studies have established the existence of the mesogastrium, dividing it into six sections. The mesogastrium is identified during surgery and utilized in surgical practice. The aim of the present study was to further investigate its role in gastric cancer prognosis.Between January 2014 and January 2018, patients from the Tongji Hospital were included in this post-hoc analysis, including data from a randomized clinical study (DCGC01; http://www.clinicaltrials.gov, NCT01978444). Mesogastria containing metastatic lymph nodes (LNs) were referred to as metastatic mesogastria. Pathology reports were examined to assess metastases in the mesogastrium. Survival was assessed using Kaplan-Meier curves and multivariable Cox models.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gastric cancer who underwent total or proximal gastrectomy in Tongji Hospital were included in this study
Key inclusion criteria (4 listed)
- older than 18, younger than 85
- primary gastric adenocarcinoma confirmed by preoperative pathology
- routine blood tests, liver and kidney functions and who health status score are within the range of tolerable surgery
- it is expected to perform radical gastrectomy through d2+cme
Key exclusion criteria (6 listed)
- pregnant or lactating women
- severe mental disorder or language communication disorder
- preoperative imaging examination or intraoperative exploration found that the patient had the following conditions: tumor involving surrounding organs requiring combined organ resection, distant organ metastasis or R0 resection could not be achieved
- those who are not suitable for laparoscopic surgery (such as extensive adhesion caused by anterior abdominal surgery and pneumoperitoneum for various reasons).
- concurrent malignancies at other sites
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 |
|---|---|---|
| D2＋CMEWhether to perform the whole mesogastric excision | Procedure or surgery | – |
Primary outcome
Overall survival
Time frame: Postoperative 5-year survival
Postoperative 5-year survival
1 secondary outcome
The Number of Mesogastria Containing Metastatic Lymph Nodes
Time frame: Postoperative 5-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- 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.
Jichao Qin, M.D./Ph.D principal investigator
Huazhong University of Science and Technology
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 Gastric Cancer, run by Jichao Qin 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 25 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (time frame: Postoperative 5-year survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2024.