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NCT Number: NCT06786169

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

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.

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Key information

Conditions

Gastric Cancer, Gastroesophageal Junction Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Cohort 1

Inclusion criteria

  • 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
  • Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences
  • R0 gastrectomy with D2 lymphadenectomy
  • Receiving adjuvant chemotherapy

Exclusion criteria

  • History of chemotherapy, radiotherapy, immunotherapy or target therapy
  • Multiple primary tumors
  • Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
  • Unavailable for R0 resection and D2 lymph node dissection.
  • Patients with stage IV gastric cancer

Cohort 2

Inclusion criteria

  • 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
  • Be proven to be primary adenocarcinoma of gastric cancer and staged III-IV by pathological evidences
  • Receiving gastrectomy
  • Receiving preoperative chemotherapy

Exclusion criteria

  • Unavailable for chemotherapy, radiotherapy, immunotherapy or target therapy
  • Multiple primary tumors
  • Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
  • Unavailable for gastrectomy

Cohort 2

Inclusion criteria

  • 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
  • Be proven to be primary adenocarcinoma of gastric cancer and staged IV by pathological evidences
  • Unavailable for gastrectomy
  • Presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1

Exclusion criteria

  • Unavailable for chemotherapy, radiotherapy, immunotherapy or target therapy
  • Multiple primary tumors
  • Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases

Treatment and study plan

psychological stress status

Other

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.

Primary outcomes

  1. Cohort 1: Disease-free survival (DFS)

    Time frame: 3-year

    The duration between the date after surgery to the date of any recurrence or death firstly

  2. Cohort 2: Pathologic complete response (pCR) rate

    Time frame: 1-month

  3. Cohort 3: Progression-free survival (PFS)

    Time frame: 1-year

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 3-year

  2. Objective Response Rate

    Time frame: through study completion, an average of 1 year

  3. Quality of life assessed by EORTC QLQ-C30.

    Time frame: 3-year

Other outcomes

  1. The correlation between gut microbiota and stress and prognosis

    Time frame: 3-year

  2. The correlation between ctDNA and chronic stress and prognosis

    Time frame: 3-year

  3. The correlation between tumor microenvironment signature and stress and prognosis

    Time frame: 3-year

  4. The correlation between peripheral stress biomarker and immune cells signature and stress and prognosis

    Time frame: 3-year

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Guo, MD

CONTACT

[email protected]

86-02164175590

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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