Gastric CancerNCT06405009
Prediction Model of Occult Omental Metastasis in Patients With Gastric Cancer
An observational study of Gastric Cancer and Omental Metastasis, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
A complete omentectomy is typically recommended during radical total gastrectomy for gastric cancer, though its impact on survival remains unclear. This study aimed to assess the frequency and risk factors of metastases in the greater omentum in gastric cancer patients undergoing gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Omental Metastasis
- What is being tested?
- Without any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factors
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2024to 30 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It included consecutive patients with a primary gastric adenocarcinoma (cT1-4N0-3M0) in whom a potentially curative total gastrectomy could be performed.
Who may be able to join
- pathological confirmation of gastric cancer
- eligibility for surgical intervention
- undergoing first rectal cancer surgery
- acquisition of written informed consent from patients and their families
- no history of hypertrophic scar or allergic predispositions
Who cannot join
- absence of postoperative pathology of the omentum
- diagnosis of multiple primary malignancies
- intraoperative discovery of widespread implant metastases within the abdominal cavity
- severe comorbidities
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yifan Cheng
Yangzhou, Jiangsu, 225000
Yifan Cheng, 8615267258283, cyfchengyifan528@sina.com
About this study
Official title: A Nomogram for Predicting Occult Omental Metastasis in Patients With Gastric Cancer
A complete omentectomy is typically recommended during radical total gastrectomy for gastric cancer, though its impact on survival remains unclear. This study aimed to assess the frequency and risk factors of metastases in the greater omentum in gastric cancer patients undergoing gastrectomy. It will involve a single prospective cohort of consecutive patients who underwent total gastrectomy with complete en bloc omentectomy and modified D2 lymphadenectomy. Post-surgery, the omentum will dissect from the gastrectomy specimen beyond the gastroepiploic vessels and examine separately for pathological assessment. The primary outcome will focus on the detection of omental metastases.
- Conditions
- Gastric Cancer, Omental Metastasis
- Being tested
- Without any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factors
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Without any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factorsOther
Without any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factors
| Study group | Role | What they receive |
|---|---|---|
| patients with omental metastases | Not described Receives: Other: Without any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factors | |
| patients without omental metastases | Not described Receives: Other: Without any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients with omental metastases
After the operation, the postoperative pathological examination of the patient indicated the presence of omental metastases
Measured: up to 2 weeks after gastric cancer surgery
patients without omental metastases
After surgery, pathological examination confirmed no omental metastases
Measured: up to 2 weeks after gastric cancer surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start22 Apr 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daorong Wang, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405009
- Sponsor's protocol ID
- NorthernJiangsu003
- Status last verified
- May 2024
- First submitted
- 22 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nomogram for Predicting Occult Omental Metastasis in Patients With Gastric Cancer
- ClinicalTrials.gov ID
- NCT06405009
- Acronym / sponsor ID
- NorthernJiangsu003
- Conditions
- Gastric Cancer, Omental Metastasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 8 May 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.
A complete omentectomy is typically recommended during radical total gastrectomy for gastric cancer, though its impact on survival remains unclear. This study aimed to assess the frequency and risk factors of metastases in the greater omentum in gastric cancer patients undergoing gastrectomy. It will involve a single prospective cohort of consecutive patients who underwent total gastrectomy with complete en bloc omentectomy and modified D2 lymphadenectomy. Post-surgery, the omentum will dissect from the gastrectomy specimen beyond the gastroepiploic vessels and examine separately for pathological assessment. The primary outcome will focus on the detection of omental metastases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with omental metastases | – | Other: Without any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factors |
| patients without omental metastases | – | Other: Without any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factors |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It included consecutive patients with a primary gastric adenocarcinoma (cT1-4N0-3M0) in whom a potentially curative total gastrectomy could be performed.
Key inclusion criteria (5 listed)
- pathological confirmation of gastric cancer
- eligibility for surgical intervention
- undergoing first rectal cancer surgery
- acquisition of written informed consent from patients and their families
- no history of hypertrophic scar or allergic predispositions
Key exclusion criteria (4 listed)
- absence of postoperative pathology of the omentum
- diagnosis of multiple primary malignancies
- intraoperative discovery of widespread implant metastases within the abdominal cavity
- severe comorbidities
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 |
|---|---|---|
| Without any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factorsWithout any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factors | Other | patients with omental metastases, patients without omental metastases |
Primary outcome
patients with omental metastases
Time frame: up to 2 weeks after gastric cancer surgery
After the operation, the postoperative pathological examination of the patient indicated the presence of omental metastases
patients without omental metastases
Time frame: up to 2 weeks after gastric cancer surgery
After surgery, pathological examination confirmed no omental metastases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 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.
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 and Omental Metastasis, run by Northern Jiangsu People's 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 5 inclusion and 4 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 8 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yifan Cheng (8615267258283, cyfchengyifan528@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients with omental metastases (time frame: up to 2 weeks after gastric cancer surgery). The study lists 2 primary outcomes in all. 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 8 May 2024.