Gastric Cancer, Gastroesophageal Junction Cancer
Conditions
Keywords
Gastric Cancer, Stress
Brief summary
This is the prospective, observational cohort study (G-Distress) to explore the associations of psychological stress with treatment and prognosis of gastric cancer. The participants including the patients diagnosed with gastric cancer who received surgery, chemotherapy and immune checkpoint inhibitors.
Interventions
The assessment of depressive and anxiety symptoms was conducted using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment 7 (GAD-7). Patients with a PHQ-9 score ≥ 5 or a GAD-7 score ≥ 5 were categorized as the stressed group.
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Cohort 1 Inclusion Criteria: 1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old, ECOG (ECOG score standard) performance status of 0 or 1 2. Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences 3. R0 gastrectomy with D2 lymphadenectomy 4. Receiving adjuvant chemotherapy
Exclusion criteria
1. History of chemotherapy, radiotherapy, immunotherapy or target therapy 2. Multiple primary tumors 3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases 4. Unavailable for R0 resection and D2 lymph node dissection. 5. Patients with stage IV gastric cancer Cohort 2 Inclusion Criteria: 1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old, ECOG (ECOG score standard) performance status of 0 or 1 2. Be proven to be primary adenocarcinoma of gastric cancer and staged III-IV by pathological evidences 3. Receiving gastrectomy 4. Receiving preoperative chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 2: Pathologic complete response (pCR) rate | 1-month | — |
| Cohort 1: Disease-free survival (DFS) | 3-year | The duration between the date after surgery to the date of any recurrence or death firstly |
| Cohort 3: Progression-free survival (PFS) | 1-year | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate | through study completion, an average of 1 year |
| Quality of life assessed by EORTC QLQ-C30. | 3-year |
| Overall survival (OS) | 3-year |
Other
| Measure | Time frame |
|---|---|
| The correlation between gut microbiota and stress and prognosis | 3-year |
| The correlation between tumor microenvironment signature and stress and prognosis | 3-year |
| The correlation between ctDNA and chronic stress and prognosis | 3-year |
| The correlation between peripheral stress biomarker and immune cells signature and stress and prognosis | 3-year |
Countries
China
Contacts
Primary ContactJing Guo, MD
Outcome results
None listed