Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT06786169
Status:
RECRUITING
Last Update Posted:
2025-01-22
First Post:
2024-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood,'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2024-09-05', 'studyFirstSubmitQcDate': '2025-01-21', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The correlation between gut microbiota and stress and prognosis', 'timeFrame': '3-year'}, {'measure': 'The correlation between ctDNA and chronic stress and prognosis', 'timeFrame': '3-year'}, {'measure': 'The correlation between tumor microenvironment signature and stress and prognosis', 'timeFrame': '3-year'}, {'measure': 'The correlation between peripheral stress biomarker and immune cells signature and stress and prognosis', 'timeFrame': '3-year'}], 'primaryOutcomes': [{'measure': 'Cohort 1: Disease-free survival (DFS)', 'timeFrame': '3-year', 'description': 'The duration between the date after surgery to the date of any recurrence or death firstly'}, {'measure': 'Cohort 2: Pathologic complete response (pCR) rate', 'timeFrame': '1-month'}, {'measure': 'Cohort 3: Progression-free survival (PFS)', 'timeFrame': '1-year'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '3-year'}, {'measure': 'Objective Response Rate', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Quality of life assessed by EORTC QLQ-C30.', 'timeFrame': '3-year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric Cancer', 'Stress'], 'conditions': ['Gastric Cancer, Gastroesophageal Junction Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'gastric cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Cohort 1\n\nInclusion Criteria:\n\n1. 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\n2. Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences\n3. R0 gastrectomy with D2 lymphadenectomy\n4. Receiving adjuvant chemotherapy\n\nExclusion Criteria:\n\n1. History of chemotherapy, radiotherapy, immunotherapy or target therapy\n2. Multiple primary tumors\n3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases\n4. Unavailable for R0 resection and D2 lymph node dissection.\n5. Patients with stage IV gastric cancer\n\nCohort 2\n\nInclusion Criteria:\n\n1. 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\n2. Be proven to be primary adenocarcinoma of gastric cancer and staged III-IV by pathological evidences\n3. Receiving gastrectomy\n4. Receiving preoperative chemotherapy\n\nExclusion Criteria:\n\n1. Unavailable for chemotherapy, radiotherapy, immunotherapy or target therapy\n2. Multiple primary tumors\n3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases\n4. Unavailable for gastrectomy\n\nCohort 2\n\nInclusion Criteria:\n\n1. 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\n2. Be proven to be primary adenocarcinoma of gastric cancer and staged IV by pathological evidences\n3. Unavailable for gastrectomy\n4. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1\n\nExclusion Criteria:\n\n1. Unavailable for chemotherapy, radiotherapy, immunotherapy or target therapy\n2. Multiple primary tumors\n3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases'}, 'identificationModule': {'nctId': 'NCT06786169', 'briefTitle': 'The Relationship of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Cohort Studies of Associations of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer (G-STRESS)', 'orgStudyIdInfo': {'id': 'G-STRESS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1: advanced gastric cancer patients receiving surgery', 'interventionNames': ['Other: psychological stress status']}, {'label': 'Cohort 2: stage III-IV gastric cancer patients receiving preoperative treatment', 'interventionNames': ['Other: psychological stress status']}, {'label': 'Cohort 3: stage IV gastric cancer patients receiving chemotherapy, immunotherapy or ta', 'interventionNames': ['Other: psychological stress status']}], 'interventions': [{'name': 'psychological stress status', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jing Guo, MD', 'role': 'CONTACT', 'email': 'gjsysu@126.com', 'phone': '86-02164175590'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dazhi Xu', 'investigatorAffiliation': 'Fudan University'}}}}