The Relationship of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
gastric cancer patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
psychological stress status
Other interventionThe 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.
Treatment groups
600 Participants
are divided into 3 treatment groupsGroup A: Cohort 1: advanced gastric cancer patients receiving surgery1 intervention
Group B: Cohort 2: stage III-IV gastric cancer patients receiving preoperative treatment1 intervention
Group C: Cohort 3: stage IV gastric cancer patients receiving chemotherapy, immunotherapy or ta1 intervention
Trial outcomes
Primary outcomes
1
Cohort 1: Disease-free survival (DFS)
The duration between the date after surgery to the date of any recurrence or death firstly
Time frame
3-year2
Cohort 2: Pathologic complete response (pCR) rate
Time frame
1-month3
Cohort 3: Progression-free survival (PFS)
Time frame
1-yearSecondary outcomes
1
Overall survival (OS)
Time frame
3-year2
Objective Response Rate
Time frame
through study completion, an average of 1 year3
Quality of life assessed by EORTC QLQ-C30.
Time frame
3-yearOther outcomes
1
The correlation between gut microbiota and stress and prognosis
Time frame
3-year2
The correlation between ctDNA and chronic stress and prognosis
Time frame
3-year3
The correlation between tumor microenvironment signature and stress and prognosis
Time frame
3-year4
The correlation between peripheral stress biomarker and immune cells signature and stress and prognosis
Time frame
3-yearSponsors and contacts
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Source ClinicalTrials.gov