Predictive Cancer ModelNCT06023966
A Clinical Prospective Study to Validate a Risk Scoring Model for the HMGC After Curative Surgery
An observational study of Predictive Cancer Model and Hepatic Metastasis, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
A previous study of investigators established a risk scoring model for occurrence of postoperative hepatic metastases in patients who underwent curative gastrectomy directly without neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Predictive Cancer Model, Hepatic Metastasis, Gastric Cancer
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Aug 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patietns who were diagnosed with gastric cancer pathologically and underwent curative gastrectomy.
Who may be able to join
- Received curative gastrectomy (D2 lymph node dissection);
- Gastric cancer without distant organ metastasis, distant lymph node metastasis and peritoneal implantation (M0) confirmed by postoperative pathology;
- No hepatic tumors and other occupying diseases, no chronic diseases such as cirrhosis and hepatitis, no hepatic schistosomiasis, no hepatic echinococcosis, no hepatic tuberculosis, and no severe fatty liver disease before the curative surgery;
- No history of intraperitoneal chemotherapy;
- No other serious concomitant diseases with satisfactory organ function;
- No history of other malignant tumors;
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- Comply with the protocol during the whole study period;
- Sign informed consent and permission of withdraw in the whole study period;
- Estimation the overall survival after surgery no less than 12 months;
- Consent to analysis of clinicopathological data and prognostic follow up;
- Karnofsky Performance Scores (KPS) more than 60.
Who cannot join
- Special histological types of gastric cancer (neuroendocrine, squamous, squamous cell, hepatoid adenocarcinoma or others);
- Gastro-esophageal junction cancer;
- Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months;
- Immunosuppressive therapists for organ transplantation;
- Seriously uncontrolled recurrent infection;
- History of other malignancies;
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- No abilities of self-knowledge or mental disorders;
- Combination of other serious diseases;
- Concurrent participation in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300060
About this study
Official title: A Clinical Prospective Study to Validate a Risk Scoring Model for the Hepatic Metastases From Gastric Cancer After Curative Surgery
A previous study of investigators established a risk scoring model for occurrence of postoperative hepatic metastases in patients who underwent curative gastrectomy directly without neoadjuvant therapy. In order to further validate the clinical applicability of abovementioned model, investigators designed this prospective study, which also included patients who received neoadjuvant therapy before surgery, with the aim of exploring the applicability of the risk scoring model to this group of patients.
Read the detailed description
The study was a single-centre, prospective study. Prospectively collected data were used to analyze the consistency between the actual outcomes of patients with or without hepatic metastases after curative gastrectomy and the predicted outcomes of the risk scoring model, in order to assess the clinical applicability of the model. In addition, analyses were performed to compare the differences in the risk of hepatic metastasis and the time interval of occurrence between patients who did not receive neoadjuvant therapy and those who received neoadjuvant therapy, as well as between patients with different outcomes after receiving neoadjuvant therapy (TRG 0-1 vs. TRG 2-3 in postoperative pathology).
- Conditions
- Predictive Cancer Model, Hepatic Metastasis, Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| with HMGC | patients with gastric cancer who developed hepatic metastasis after curative gastrectomy | |
| without HMGC | patients with gastric cancer who did not developed hepatic metastasis after curative gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatic metastasis
Postoperative telephone follow-up was performed in patients with gastric cancer undergoing curative gastrectomy to determine the occurrence of hepatic metastasis.
Measured: 2 years after curative surgery
Secondary outcomes (1)
interval between the surgery and hepatic metastasis
Postoperative telephone follow-up was performed in patients with gastric cancer undergoing curative gastrectomy to determine the interval between the gastrectomy and development of hepatic metastasis.
Measured: 2 years after curative surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Sep 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Predictive Cancer ModelStudies 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
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023966
- Sponsor's protocol ID
- DJY003
- Status last verified
- Aug 2023
- First submitted
- 29 Aug 2023
- Last updated
- 20 Nov 2025
- 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 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Prospective Study to Validate a Risk Scoring Model for the Hepatic Metastases From Gastric Cancer After Curative Surgery
- ClinicalTrials.gov ID
- NCT06023966
- Acronym / sponsor ID
- DJY003
- Conditions
- Predictive Cancer Model, Hepatic Metastasis, Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 5 Sep 2023 (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 previous study of investigators established a risk scoring model for occurrence of postoperative hepatic metastases in patients who underwent curative gastrectomy directly without neoadjuvant therapy. In order to further validate the clinical applicability of abovementioned model, investigators designed this prospective study, which also included patients who received neoadjuvant therapy before surgery, with the aim of exploring the applicability of the risk scoring model to this group of patients.
Detailed description
The study was a single-centre, prospective study. Prospectively collected data were used to analyze the consistency between the actual outcomes of patients with or without hepatic metastases after curative gastrectomy and the predicted outcomes of the risk scoring model, in order to assess the clinical applicability of the model. In addition, analyses were performed to compare the differences in the risk of hepatic metastasis and the time interval of occurrence between patients who did not receive neoadjuvant therapy and those who received neoadjuvant therapy, as well as between patients with different outcomes after receiving neoadjuvant therapy (TRG 0-1 vs. TRG 2-3 in postoperative pathology).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with HMGC | – | –patients with gastric cancer who developed hepatic metastasis after curative gastrectomy |
| without HMGC | – | –patients with gastric cancer who did not developed hepatic metastasis after curative gastrectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patietns who were diagnosed with gastric cancer pathologically and underwent curative gastrectomy.
Key inclusion criteria (11 listed)
- Received curative gastrectomy (D2 lymph node dissection);
- Gastric cancer without distant organ metastasis, distant lymph node metastasis and peritoneal implantation (M0) confirmed by postoperative pathology;
- No hepatic tumors and other occupying diseases, no chronic diseases such as cirrhosis and hepatitis, no hepatic schistosomiasis, no hepatic echinococcosis, no hepatic tuberculosis, and no severe fatty liver disease before the curative surgery;
- No history of intraperitoneal chemotherapy;
- No other serious concomitant diseases with satisfactory organ function;
Key exclusion criteria (9 listed)
- Special histological types of gastric cancer (neuroendocrine, squamous, squamous cell, hepatoid adenocarcinoma or others);
- Gastro-esophageal junction cancer;
- Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months;
- Immunosuppressive therapists for organ transplantation;
- Seriously uncontrolled recurrent infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hepatic metastasis
Time frame: 2 years after curative surgery
Postoperative telephone follow-up was performed in patients with gastric cancer undergoing curative gastrectomy to determine the occurrence of hepatic metastasis.
1 secondary outcome
interval between the surgery and hepatic metastasis
Time frame: 2 years after curative surgery
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 20 Nov 2025.
- 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 Predictive Cancer Model and Hepatic Metastasis, run by Tianjin Medical University Cancer Institute and 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 11 inclusion and 9 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 20 Nov 2025. 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?
hepatic metastasis (time frame: 2 years after curative surgery). 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 20 Nov 2025.