Clinical trial NCT04819958: The Effect of Immunological Heterogeneity of Tumor Microenvironment in the Prognosis of Gastric Cancer
Official title: The Effect of Immunological Heterogeneity of Tumor Microenvironment in the Short-term Outcome and Long-term Outcome of Patients With Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stomach Cancer
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are assigned to undergo gastrectomy for gastric cancer are included.

Brief summary: The purpose of this study is to explore the effect of immunological heterogeneity of tumor microenvironment in the short-term outcome and long-term outcome of patients with gastric cancer.

Detailed description: A prospective cohort study will be performed to explore the effect of immunological heterogeneity of tumor microenvironment in the short-term outcome and long-term outcome of patients with gastric cancer. The evaluation parameters are perioperative clinical efficacy, postoperative complications, and 3-year survival and recurrence rates.

Eligibility criteria: Inclusion Criteria:

1. Age from 18 to 80 years
2. Histology confirmed gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy.
3. Clinical stage: cTNM: stage I or above at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition
4. Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)
5. Clinically fit for gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
6. Written informed consent

Exclusion Criteria:

1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection
4. History of other malignant diseases within the past five years
5. History of unstable angina or myocardial infarction within the past six months
6. History of a cerebrovascular accident within the past six months
7. History of continuous systematic administration of corticosteroids within one month
8. Requirement of simultaneous surgery for other diseases
9. Emergency surgery due to complication (bleeding, obstruction, or perforation) caused by gastric cancer
10. Forced expiratory volume in 1 second (FEV1)\<50% of predicted values
11. Inclusion in another clinical trial

Primary outcomes:
measure: 3-year disease free survival rate
timeFrame: 36 months
Secondary outcomes:
measure: 3-year overall survival rate
timeFrame: 36 months
measure: Morbidity rates
timeFrame: 30 days
measure: Mortality rates
timeFrame: 30 days
measure: Total number of retrieved lymph nodes
timeFrame: One month after surgery
measure: Intraoperative morbidity rates
timeFrame: 1 day
measure: The variation of white blood cell count
timeFrame: Preoperative 7 days and postoperative 1, 3, and 5 days
measure: The variation of hemoglobin
timeFrame: Preoperative 7 days and postoperative 1, 3, and 5 days
measure: The variation of C-reactive protein
timeFrame: Preoperative 7 days and postoperative 1, 3, and 5 days
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: Time to first ambulation
timeFrame: 30 days
measure: Time to first flatus
timeFrame: 30 days
measure: Time to first liquid diet
timeFrame: 30 days
measure: Time to first soft diet
timeFrame: 30 days
measure: Duration of postoperative hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Gastric Surgery
state: Fujian
Study officials:
References:
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