Glioblastoma Clinical Trial
Official title:
Correlation of Psychological Stress With Quality of Life and Efficacy of Immunotherapy Response in Patients With Newly Diagnosed Glioblastoma
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. The 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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2025 |
Est. primary completion date | August 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - age =18 years - Karnofsky Performance Score = 70 % - histologically confirmed, previously untreated GBM - receiving a standardized chemoradiotherapy regimen - no previous history of mental illness, drug abuse, or alcohol abuse - ability to communicate and read and write independently - willing and able to comply with the protocol as judged by the investigator's signed informed consent. Exclusion Criteria: - 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. - pregnancy or breast-feeding - 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. |
Country | Name | City | State |
---|---|---|---|
China | Henan Provincial People's Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Henan Provincial People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Overall survival rate at 12 months | OS-12 is the proportion of participants in the analysis population who remain alive for at least twelve months after diagnosis. | From the time of diagnosis to 12 months | |
Other | Progression-free survival | Median time from allocation to first documented disease progression as per RANO or death due to any cause, whichever occurs first. | Up to 3 years after diagnosis | |
Primary | Tumor mutation burden(TMB) | The proportion of tumor mutational burden =10 Mut/MB in the population who remain progression-free after diagnosis. | From the time of diagnosis to 12 months | |
Primary | The proportion of patients with high-level psychological stress | 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. | From the time of diagnosis to 12 months | |
Secondary | The Short Form-36 (SF-36) | 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. | From the time of diagnosis to 12 months | |
Secondary | Progression-free survival at 6 months | The proportion of participants in the analysis population who remain progression-free for at least six months after diagnosis. | From the time of diagnosis to 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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