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RECRUITING

NCT06786169

The Relationship of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: Cohort Studies of Associations of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer (G-STRESS)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2024-09-05

Completion Date

2029-09-15

Last Updated

2025-01-22

Healthy Volunteers

Conditions

Gastric Cancer, Gastroesophageal Junction Cancer

Interventions

OTHER

psychological stress status

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.

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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China