Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-06 @ 1:21 AM
Study NCT ID:
NCT06964503
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-09
First Post:
2025-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Psychological Stress on Treatment Response and Prognosis in Lung Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2031-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2025-05-01', 'studyFirstSubmitQcDate': '2025-05-01', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The correlation between gut microbiota and chronic stress', 'timeFrame': '5 years', 'description': 'The baseline faeces is collected and assessed by 16S rRNA sequencing. And explore the association between gut microbiota and chronic stress during the enrolled observation process'}, {'measure': 'The correlation between peripheral stress biomarker and immune cells signature and chronic stress', 'timeFrame': '5 years', 'description': 'The baseline peripheral venous blood is collected. The stress biomarkers including epinephrine, cytokines, norepinephrine, cortisol and ACTH. The peripheral immune cells signature and assessed by flow cytometry, including T lymphocytes, B lymphocytes, NK lymphocytes, macrophagocyte, and DC cells.'}, {'measure': 'The correlation between tumor microenvironment signature and chronic stress', 'timeFrame': '5 years', 'description': 'The baseline paraffin-embedded tissue is collected and assessed by multiplex immunohistochemistry, including T lymphocytes, B lymphocytes, NK lymphocytes, macrophagocyte, and DC cells. And explore the association between tumor microenvironment signature and chronic stress during the enrolled observation process.'}], 'primaryOutcomes': [{'measure': 'Advanced Stage Cohort: Progression-free survival (PFS)', 'timeFrame': '3 years', 'description': 'Time from the beginning of first-line immunotherapy to the first progression (PD) in patients with lung cancer'}, {'measure': 'Early-Stage Surgical Cohort: Disease-free survival (DFS)', 'timeFrame': '5 years', 'description': 'The duration between the date after surgery to the date of any recurrence or death firstly'}, {'measure': 'neoadjuvant therapy Cohort: Pathologic complete response (pCR) rate', 'timeFrame': '3 years', 'description': 'pCR is no viable tumor cells in tumor bed and lymph nodes. The pCR rate is the proportion of patients with a pathologic complete response.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '5 years', 'description': 'Overall survival (OS) is defined as the duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': '3 years', 'description': 'The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)'}]}, 'conditionsModule': {'conditions': ['Cancer of Lung', 'Depression Disorders', 'Anxiety Disorder/Anxiety State']}, 'descriptionModule': {'briefSummary': 'This study explores how psychological stress may influence the treatment response and long-term outcomes in patients with lung cancer. While advances in surgery, chemotherapy, immunotherapy, and targeted therapies have improved survival, emotional well-being remains an often-overlooked factor. We aim to investigate whether high levels of stress, anxiety, or depression at the time of diagnosis or during treatment are linked to poorer responses to therapy or shorter survival. By identifying these associations, the study hopes to highlight the importance of psychological care as part of comprehensive cancer treatment. The findings may inform future strategies to integrate mental health support into routine care for patients with both early-stage and advanced lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The participants including the patients diagnosed with advanced non-small-cell lung cancer (NSCLC) who received the first-line therapy or neoadjuvant therapy of ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early small-cell lung cancer (SCLC) receiving surgery.', 'eligibilityCriteria': "Inclusion Criteria (Advanced Stage Cohort):\n\nAge ≥ 18 years; Histologically confirmed diagnosis of lung cancer (including both non-small cell lung cancer \\[NSCLC\\] and small cell lung cancer \\[SCLC\\]); Unresectable, locally advanced, metastatic, or recurrent disease classified as stage IIIB-IV according to the 8th edition of the AJCC TNM staging system; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; No prior systemic treatment (e.g., chemotherapy, anti-angiogenic therapy, targeted therapy, or immunotherapy); At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1); Able to provide informed consent and voluntarily agree to participate in the study.\n\nExclusion Criteria:\n\nCombined with other malignant tumors in the past 3 years; Concurrent acute or chronic psychiatric disorders; Current receiving anti-depressive or anti-anxiety therapy; Previous treatment with other clinical drug trials; Patients with symptomatic brain metastasis; Can't cooperate with psychological scale assessment;\n\nInclusion Criteria (Early-Stage Surgical Cohort) Age ≥18 years; Pathologically diagnosed as non-small-cell lung cancer； Pathologically stage conformed as early stage of IA-IIIA Available for tumor tissue samples； Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy ); Receiving radical surgery; Informed and agreed to participate in the study;\n\nExclusion Criteria:\n\nCombined with other malignant tumors in the past 3 years; Concurrent acute or chronic psychiatric disorders; Current receiving anti-depressive or anti-anxiety therapy; Previous treatment with other clinical drug trials; Can't cooperate with psychological scale assessment;\n\nInclusion Criteria (neoadjuvant therapy Cohort) Adults aged ≥18 years; Histologically confirmed diagnosis of non-small cell lung cancer \\[NSCLC\\]; Clinical stage IB-IIIB based on the 8th edition of the AJCC TNM staging system and deemed potentially resectable after neoadjuvant therapy; At least one measurable lesion can be evaluated according to the RECIST 1.1 standard; Planned to receive or currently receiving neoadjuvant systemic therapy (e.g., chemotherapy, targeted therapy, or immunotherapy) with curative intent; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 prior to neoadjuvant treatment; No prior systemic treatment before the initiation of neoadjuvant therapy; Able to provide informed consent and voluntarily agree to participate in the study\n\nExclusion Criteria:\n\nCombined with other malignant tumors in the past 3 years; Concurrent acute or chronic psychiatric disorders; Current receiving anti-depressive or anti-anxiety therapy; Previous treatment with other clinical drug trials; Can't cooperate with psychological scale assessment;"}, 'identificationModule': {'nctId': 'NCT06964503', 'briefTitle': 'Impact of Psychological Stress on Treatment Response and Prognosis in Lung Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'Impact of Psychological Stress on Treatment Response and Prognosis in Lung Cancer Patients', 'orgStudyIdInfo': {'id': 'LUNG-MOOD-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Advanced Stage Cohort', 'interventionNames': ['Other: Exposure: psychological stress status']}, {'label': 'Early-Stage Surgical Cohort', 'interventionNames': ['Other: Exposure: psychological stress status']}, {'label': 'neoadjuvant therapy Cohort', 'interventionNames': ['Other: Exposure: psychological stress status']}], 'interventions': [{'name': 'Exposure: 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': ['Advanced Stage Cohort', 'Early-Stage Surgical Cohort', 'neoadjuvant therapy Cohort']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD', 'investigatorFullName': 'Jianxing He', 'investigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}}}}