Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-31 @ 9:52 PM
Study NCT ID:
NCT05515133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-09-27
First Post:
2022-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Psychological Stress and Disease Progression in Newly Diagnosed Glioblastoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000087602', 'term': 'Anthropogenic Effects'}], 'ancestors': [{'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-25', 'studyFirstSubmitDate': '2022-08-21', 'studyFirstSubmitQcDate': '2022-08-24', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall survival rate at 12 months', 'timeFrame': 'From the time of diagnosis to 12 months', 'description': 'OS-12 is the proportion of participants in the analysis population who remain alive for at least twelve months after diagnosis.'}, {'measure': 'Progression-free survival', 'timeFrame': 'Up to 3 years after diagnosis', 'description': 'Median time from allocation to first documented disease progression as per RANO or death due to any cause, whichever occurs first.'}], 'primaryOutcomes': [{'measure': 'Tumor mutation burden（TMB）', 'timeFrame': 'From the time of diagnosis to 12 months', 'description': 'The proportion of tumor mutational burden ≥10 Mut/MB in the population who remain progression-free after diagnosis.'}, {'measure': 'The proportion of patients with high-level psychological stress', 'timeFrame': 'From the time of diagnosis to 12 months', 'description': 'The self-report questionnaire of Perceived Stress Scale（PSS）is used to measure the psychological stress level of patients, with 43 as the critical value, more than or equal to 43 as the high level of psychological stress, less than 43 as the low level of psychological stress.'}], 'secondaryOutcomes': [{'measure': 'The Short Form-36 (SF-36)', 'timeFrame': 'From the time of diagnosis to 12 months', 'description': 'The questionnaire of Short Form-36 (SF-36) is used health-related quality-of-life measure in participants outcomes. The scale contains 9 dimensions with a total score of 100 points.'}, {'measure': 'Progression-free survival at 6 months', 'timeFrame': 'From the time of diagnosis to 12 months', 'description': 'The proportion of participants in the analysis population who remain progression-free for at least six months after diagnosis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glioblastoma', 'psychological stress', 'Immune microenvironment'], 'conditions': ['Glioblastoma']}, 'descriptionModule': {'briefSummary': 'It is a single-center, prospective, observational，non-randomized study of newly diagnosed glioblastoma patients conducted in a tertiary hospital. The investigators examine the psychological stress, immune biomarker changes, quality of life, and disease progression of patients with glioblastoma at five-time points.\n\nThe study had two cohorts, a high-stress cohort and a low-stress cohort, which are grouped after initial recruitment. Both groups undergo total resection of tumors and received 3 months of standardized treatment with radiotherapy and chemotherapy. Neither participants nor doctors but the researcher can choose which group participants are in. No one knows if one study group is better or worse than the other.', 'detailedDescription': "Glioblastoma (GBM) is the most common and aggressive primary malignant brain tumor affecting adults, with a median survival of 12-16 months after diagnosis. The diagnosis of a malignant tumor has a huge impact on patients' psychology, which is easy to lead to patients in a state of stress.\n\nThe high-stress level can lead to a change in patients' health behaviors and correlates with the prognosis outcome. In addition, psychological stress can lead to changes in the immune microenvironment, but disease progression and quality of life in glioblastoma have not been adequately demonstrated.\n\nGrouping process: 60 patients are expected to be enrolled. After enrollment, participants will receive regular tumor in situ fluid (fluid within the surgical cavity, TISF) sampling for tumor mutation burden（TMB) analysis and recceive regular MRI. Under the standard of care, participants will receive psychological stress assessment after being diagnosed. according to five psychological scales, and the patients were grouped according to the cut-off value of each scale, the psychological stress of the patients is measured by distress thermometer (DT), perceived stress scale (PSS), anxiety/depression (HADS), VAS stress, and fear of disease progression scale（PoP-Q-SF).\n\nPrimary study objectives:\n\n• To evaluate the changes in immune markers of acute and chronic psychological stress in patients with glioblastoma after diagnosis.\n\nSecondary study objectives:\n\n* To evaluate the quality of life of patients with different psychological stress levels.\n* To evaluate the progression-free survival of patients with different psychological stress levels.\n\nExploratory objectives:\n\n* To evaluate the effect of managing the patient's psychological stress on the patient's immune microenvironment.\n* To evaluate the incidence of mental illness.\n* To evaluate the patient treatment compliance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'newly diagnosed glioblastoma', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age ≥18 years\n* Karnofsky Performance Score ≥ 70 %\n* histologically confirmed, previously untreated GBM\n* receiving a standardized chemoradiotherapy regimen\n* no previous history of mental illness, drug abuse, or alcohol abuse\n* ability to communicate and read and write independently\n* willing and able to comply with the protocol as judged by the investigator's signed informed consent.\n\nExclusion Criteria:\n\n* Patients who have any other disease, either metabolic or psychological, or who have any evidence on clinical examination or special investigations (including laboratory findings) which give reasonable suspicion of a condition that interferes with the adequate measurement of the stress axis (e.g. chronic use of corticosteroids ≥ 3 months before study entry for diseases other than glioblastoma, (dexamethasone use in the context of glioblastoma is allowed) Severe, medically treated psychiatric disorder prior to the diagnosis of glioblastoma Participation in a study with investigational drugs.\n* pregnancy or breast-feeding\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurologic deficits that interfere with the planned walking tests, dementia, or confusional state."}, 'identificationModule': {'nctId': 'NCT05515133', 'briefTitle': 'Correlation Between Psychological Stress and Disease Progression in Newly Diagnosed Glioblastoma Patients', 'organization': {'class': 'OTHER', 'fullName': "Henan Provincial People's Hospital"}, 'officialTitle': 'Correlation of Psychological Stress With Quality of Life and Efficacy of Immunotherapy Response in Patients With Newly Diagnosed Glioblastoma', 'orgStudyIdInfo': {'id': 'HenanPPH-Glioma'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation group of newly diagnosed glioblastoma patients with high-level psychological stress', 'description': 'The patients had high threshold levels of perceived stress, psychological distress, fear, anxiety, and depression as assessed by psychologists', 'interventionNames': ['Other: stressors']}, {'label': 'Observation group of newly diagnosed glioblastoma patients with low-level psychological stress', 'description': 'The patients had lower than threshold levels of perceived stress, psychological distress, fear, anxiety, and depression as assessed by psychologists'}], 'interventions': [{'name': 'stressors', 'type': 'OTHER', 'description': 'Patients are exposed to stressful situations related to the diagnosis and treatment of the disease', 'armGroupLabels': ['Observation group of newly diagnosed glioblastoma patients with high-level psychological stress']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Xingyao Bu', 'role': 'CONTACT', 'email': 'xingyaob@zzu.edu.cn'}], 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Xingyao Bu, PhD', 'role': 'CONTACT', 'email': 'xingyaobu@zzu.edu.cn', 'phone': '+86037165580295'}, {'name': 'Jie Mei, MD', 'role': 'CONTACT', 'email': 'meijie@zzu.edu.cn', 'phone': '+8615188318262'}], 'overallOfficials': [{'name': 'Xingyao Bu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Henan Provincial People's Hospital"}, {'name': 'Jie Mei, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Henan Provincial People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}