Clinical trial NCT06786169: The Relationship of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer
Official title: Cohort Studies of Associations of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer (G-STRESS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer, Gastroesophageal Junction Cancer
Keywords: Gastric Cancer
Stress
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 600
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: PROBABILITY_SAMPLE
Study population: gastric cancer patients

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.


Eligibility 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

Exclusion Criteria:

1. Unavailable for 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 gastrectomy

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 IV by pathological evidences
3. Unavailable for gastrectomy
4. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1

Exclusion Criteria:

1. Unavailable for 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

Primary outcomes:
measure: Cohort 1: Disease-free survival (DFS)
timeFrame: 3-year
measure: Cohort 2: Pathologic complete response (pCR) rate
timeFrame: 1-month
measure: Cohort 3: Progression-free survival (PFS)
timeFrame: 1-year
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 3-year
measure: Objective Response Rate
timeFrame: through study completion, an average of 1 year
measure: Quality of life assessed by EORTC QLQ-C30.
timeFrame: 3-year
Other outcomes:
measure: The correlation between gut microbiota and stress and prognosis
timeFrame: 3-year
measure: The correlation between ctDNA and chronic stress and prognosis
timeFrame: 3-year
measure: The correlation between tumor microenvironment signature and stress and prognosis
timeFrame: 3-year
measure: The correlation between peripheral stress biomarker and immune cells signature and stress and prognosis
timeFrame: 3-year
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: