Gastric Cancer StageMANCT05592925
Association Between Multiple Coagulation-related Factors and Lymph Node Metastasis in Patients With Gastric Cancer: A Retrospective Cohort Study
An observational study of Gastric Cancer Stage and Lymph Node Metastasis, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
We initially selected a total of 1128 patients with primary gastric cancer who presented at Shandong Provincial Hospital between January 2018 and October 2022, and retrospectively collected their clinical and pathological data. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer Stage, Lymph Node Metastasis
- What is being tested?
- coagulation-related factors
- How many people
- 516 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with primary gastric cancer
Who may be able to join
- patients with primary gastric malignant tumors,
- patients who underwent radical resection of gastric cancer,
- patients with a postoperative pathology of adenocarcinoma or signet ring cell carcinoma according to the WTO pathological classification,
Who cannot join
- patients who have distant metastases, such as liver or lung metastases, were found on preoperative ultrasound and computed tomography (CT) examinations,
- patients who have received preoperative neoadjuvant chemotherapy,
- patients who take anticoagulant drugs (such as aspirin) prior to surgery,
- patients who had any previous coagulation disorder.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250021
Feng Tian, Doctor, 18866102886, tianfeng@sdu.edu.cn
About this study
We initially selected a total of 1128 patients with primary gastric cancer who presented at Shandong Provincial Hospital between January 2018 and October 2022, and retrospectively collected their clinical and pathological data. And retrospectively analyzed preoperative baseline characteristics, preoperative laboratory tests, and postoperative pathological results for these patients
- Conditions
- Gastric Cancer Stage, Lymph Node Metastasis
- Being tested
- coagulation-related factors
- Keywords
- gastric cancer, lymph node metastasis, maximum amplitude, prognostic factor
- Medical subject headings
- Lymphatic Metastasis, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coagulation-related factorsDiagnostic test
We retrospectively evaluated the relationship between lymph node metastasis and coagulation-related factors in 516 patients with T4a stage gastric cancer.
| Study group | Role | What they receive |
|---|---|---|
| N0 | gastric cancer patients with no lymph node metastasis Receives: Diagnostic Test: coagulation-related factors | |
| N+ | gastric cancer patients with lymph node metastasis, including patients with N1, N2 and N3 stage cancer Receives: Diagnostic Test: coagulation-related factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative coagulation-related factors (MA values) of patients
MA values(mm). Measure the data of preoperative MA values in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.
Measured: Three years
Preoperative coagulation-related factors (platelet counts) of patients
Platelet counts（x10^9/L). Measure the data of preoperative platelet counts in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.
Measured: Three years
Preoperative coagulation-related factors (fibrinogen levels) of patients
Fibrinogen levels (g/L). Measure the data of preoperative fibrinogen levels in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.
Measured: Three years
Preoperative coagulation-related factors (D-dimer) of patients
D-dimer (mg/L). Measure the data of preoperative D-dimer in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.
Measured: Three years
Postoperative pathological results of tumor T stage.
Recording the postoperative pathological tumor T stage in 516 patients with gastric cancer.
Measured: Three years
Postoperative pathological results of tumor N stage.
Recording the postoperative pathological tumor N stage in 516 patients with gastric cancer.
Measured: Three years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start1 Jan 2018
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer StageStudies 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
- 516 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Feng Tian, Shandong Provincial Hospital
- Investigators
- Feng Tian, Doctor, Principal investigator, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592925
- Sponsor's protocol ID
- FTian
- Acronym
- MA
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the article is published, the original data can be obtained by contacting the project leader.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Multiple Coagulation-related Factors and Lymph Node Metastasis in Patients With Gastric Cancer: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05592925
- Acronym / sponsor ID
- MA / FTian
- Conditions
- Gastric Cancer Stage, Lymph Node Metastasis
- Keywords
- gastric cancer, lymph node metastasis, maximum amplitude, prognostic factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 516 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 25 Oct 2022 (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.
We initially selected a total of 1128 patients with primary gastric cancer who presented at Shandong Provincial Hospital between January 2018 and October 2022, and retrospectively collected their clinical and pathological data. And retrospectively analyzed preoperative baseline characteristics, preoperative laboratory tests, and postoperative pathological results for these patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N0 | – | Diagnostic Test: coagulation-related factorsgastric cancer patients with no lymph node metastasis |
| N+ | – | Diagnostic Test: coagulation-related factorsgastric cancer patients with lymph node metastasis, including patients with N1, N2 and N3 stage cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with primary gastric cancer
Key inclusion criteria (3 listed)
- patients with primary gastric malignant tumors,
- patients who underwent radical resection of gastric cancer,
- patients with a postoperative pathology of adenocarcinoma or signet ring cell carcinoma according to the WTO pathological classification,
Key exclusion criteria (4 listed)
- patients who have distant metastases, such as liver or lung metastases, were found on preoperative ultrasound and computed tomography (CT) examinations,
- patients who have received preoperative neoadjuvant chemotherapy,
- patients who take anticoagulant drugs (such as aspirin) prior to surgery,
- patients who had any previous coagulation disorder.
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 |
|---|---|---|
| coagulation-related factorsWe retrospectively evaluated the relationship between lymph node metastasis and coagulation-related factors in 516 patients with T4a stage gastric cancer. | Diagnostic test | N+, N0 |
Primary outcome
Preoperative coagulation-related factors (MA values) of patients
Time frame: Three years
MA values(mm). Measure the data of preoperative MA values in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.
Preoperative coagulation-related factors (platelet counts) of patients
Time frame: Three years
Platelet counts（x10^9/L). Measure the data of preoperative platelet counts in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.
Preoperative coagulation-related factors (fibrinogen levels) of patients
Time frame: Three years
Fibrinogen levels (g/L). Measure the data of preoperative fibrinogen levels in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.
Preoperative coagulation-related factors (D-dimer) of patients
Time frame: Three years
D-dimer (mg/L). Measure the data of preoperative D-dimer in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.
Postoperative pathological results of tumor T stage.
Time frame: Three years
Recording the postoperative pathological tumor T stage in 516 patients with gastric cancer.
Postoperative pathological results of tumor N stage.
Time frame: Three years.
Recording the postoperative pathological tumor N stage in 516 patients with gastric cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: No. After the article is published, the original data can be obtained by contacting the project leader.
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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.
Feng Tian, Doctor principal investigator
Shandong Provincial Hospital
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 Stage and Lymph Node Metastasis, run by Shandong Provincial 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 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 25 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?
Contact Feng Tian, Doctor (18866102886, tianfeng@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative coagulation-related factors (MA values) of patients (time frame: Three years). The study lists 6 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 25 Oct 2022; AzTrials last refreshed its copy on 30 Oct 2026.