NCT06786169

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Sep 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Sep 2024Sep 2029

First Submitted

Initial submission to the registry

September 5, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

September 5, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2029

Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

September 5, 2024

Last Update Submit

January 21, 2025

Conditions

Gastric Cancer, Gastroesophageal Junction Cancer

Keywords

Gastric CancerStress

Outcome Measures

Primary Outcomes (3)

  • Cohort 1: Disease-free survival (DFS)

    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

    1-month

  • Cohort 3: Progression-free survival (PFS)

    1-year

Secondary Outcomes (3)

  • Overall survival (OS)

    3-year

  • Objective Response Rate

    through study completion, an average of 1 year

  • Quality of life assessed by EORTC QLQ-C30.

    3-year

Other Outcomes (4)

  • The correlation between gut microbiota and stress and prognosis

    3-year

  • The correlation between ctDNA and chronic stress and prognosis

    3-year

  • The correlation between tumor microenvironment signature and stress and prognosis

    3-year

  • +1 more other outcomes

Study Arms (3)

Cohort 1: advanced gastric cancer patients receiving surgery

Other: psychological stress status

Cohort 2: stage III-IV gastric cancer patients receiving preoperative treatment

Other: psychological stress status

Cohort 3: stage IV gastric cancer patients receiving chemotherapy, immunotherapy or ta

Other: psychological stress status

Interventions

psychological stress statusOTHER

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: advanced gastric cancer patients receiving surgeryCohort 2: stage III-IV gastric cancer patients receiving preoperative treatmentCohort 3: stage IV gastric cancer patients receiving chemotherapy, immunotherapy or ta

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

gastric cancer patients

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood,

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Jing Guo, MD

CONTACT

86-02164175590gjsysu@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 5, 2024

First Posted

January 22, 2025

Study Start

September 5, 2024

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2029

Last Updated

January 22, 2025

Record last verified: 2025-01

Locations

CN(1)