Clinical trial NCT06023966: A Clinical Prospective Study to Validate a Risk Scoring Model for the HMGC After Curative Surgery
Official title: A Clinical Prospective Study to Validate a Risk Scoring Model for the Hepatic Metastases From Gastric Cancer After Curative Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Predictive Cancer Model
Hepatic Metastasis
Gastric Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patietns who were diagnosed with gastric cancer pathologically and underwent curative gastrectomy.

Brief summary: A previous study of investigators established a risk scoring model for the 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).

Eligibility criteria: Inclusion Criteria:

1. Received curative gastrectomy (D2 lymph node dissection);
2. Gastric cancer without distant organ metastasis, distant lymph node metastasis and peritoneal implantation (M0) confirmed by postoperative pathology;
3. 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;
4. No history of intraperitoneal chemotherapy;
5. No other serious concomitant diseases with satisfactory organ function;
6. No history of other malignant tumors;
7. Comply with the protocol during the whole study period;
8. Sign informed consent and permission of withdraw in the whole study period;
9. Estimation the overall survival after surgery no less than 12 months;
10. Consent to analysis of clinicopathological data and prognostic follow up;
11. Karnofsky Performance Scores (KPS) more than 60.

Exclusion Criteria:

1. Special histological types of gastric cancer (neuroendocrine, squamous, squamous cell, hepatoid adenocarcinoma or others);
2. Gastro-esophageal junction cancer;
3. Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months;
4. Immunosuppressive therapists for organ transplantation;
5. Seriously uncontrolled recurrent infection;
6. History of other malignancies;
7. No abilities of self-knowledge or mental disorders;
8. Combination of other serious diseases;
9. Concurrent participation in other clinical trials.

Primary outcomes:
measure: hepatic metastasis
timeFrame: 2 years after curative surgery
Secondary outcomes:
measure: interval between the surgery and hepatic metastasis
timeFrame: 2 years after curative surgery
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Cancer Hospital of Tianjin Medical University
state: 天津
Study officials:
References: