Gastric Cancer, Gastroesophageal Junction CancerNCT06786169
The Relationship of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer
An observational study of Gastric Cancer, Gastroesophageal Junction Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- psychological stress status
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2024to 15 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: gastric cancer patients
Who may be able to join
- 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
- 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
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- Receiving gastrectomy
- Receiving preoperative chemotherapy
- 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
Who cannot join
- 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
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- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
About this study
Official title: 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.
- Being tested
- psychological stress status
- Keywords
- Gastric Cancer, Stress
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: advanced gastric cancer patients receiving surgery | Not described Receives: Other: psychological stress status | |
| Cohort 2: stage III-IV gastric cancer patients receiving preoperative treatment | Not described Receives: Other: psychological stress status | |
| Cohort 3: stage IV gastric cancer patients receiving chemotherapy, immunotherapy or ta | Not described Receives: Other: psychological stress status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Disease-free survival (DFS)
The duration between the date after surgery to the date of any recurrence or death firstly
Measured: 3-year
Cohort 2: Pathologic complete response (pCR) rate
Measured: 1-month
Cohort 3: Progression-free survival (PFS)
Measured: 1-year
Secondary outcomes (3)
Overall survival (OS)
Measured: 3-year
Objective Response Rate
Measured: through study completion, an average of 1 year
Quality of life assessed by EORTC QLQ-C30.
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start5 Sep 2024
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer, Gastroesophageal Junction CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dazhi Xu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786169
- Sponsor's protocol ID
- G-STRESS
- Status last verified
- Jan 2025
- First submitted
- 5 Sep 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Studies of Associations of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer (G-STRESS)
- ClinicalTrials.gov ID
- NCT06786169
- Acronym / sponsor ID
- G-STRESS
- Keywords
- Gastric Cancer, Stress
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2029 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- gastric cancer patients
Key inclusion criteria (12 listed)
- 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
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychological stress statusThe 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. | Other | Cohort 1: advanced gastric cancer patients receiving surgery, Cohort 2: stage III-IV gastric cancer patients receiving preoperative treatment, Cohort 3: stage IV gastric cancer patients receiving chemotherapy, immunotherapy or ta |
Primary outcome
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
Cohort 2: Pathologic complete response (pCR) rate
Time frame: 1-month
Cohort 3: Progression-free survival (PFS)
Time frame: 1-year
3 secondary outcomes
Overall survival (OS)
Time frame: 3-year
Objective Response Rate
Time frame: through study completion, an average of 1 year
Quality of life assessed by EORTC QLQ-C30.
Time frame: 3-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, Gastroesophageal Junction Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Guo, MD (86-02164175590, gjsysu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: Disease-free survival (DFS) (time frame: 3-year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.