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

January 21, 2025 updated by: Dazhi Xu, Fudan University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jing Guo, MD
  • Phone Number: 86-02164175590
  • Email: gjsysu@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

gastric cancer patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1: advanced gastric cancer patients receiving surgery
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 2: stage III-IV gastric cancer patients receiving preoperative treatment
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 3: stage IV gastric cancer patients receiving chemotherapy, immunotherapy or ta
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3-year
Cohort 2: Pathologic complete response (pCR) rate
Time Frame: 1-month
1-month
Cohort 3: Progression-free survival (PFS)
Time Frame: 1-year
1-year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: 3-year
3-year
Objective Response Rate
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Quality of life assessed by EORTC QLQ-C30.
Time Frame: 3-year
3-year

Other Outcome Measures

Outcome Measure
Time Frame
The correlation between gut microbiota and stress and prognosis
Time Frame: 3-year
3-year
The correlation between ctDNA and chronic stress and prognosis
Time Frame: 3-year
3-year
The correlation between tumor microenvironment signature and stress and prognosis
Time Frame: 3-year
3-year
The correlation between peripheral stress biomarker and immune cells signature and stress and prognosis
Time Frame: 3-year
3-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2024

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2029

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G-STRESS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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