About this trial
It is a single-center, prospective, observational, non-randomized study of newly diagnosed oligodendroglioma patients conducted in a tertiary hospital. The investigators conduct an eight-year follow-up, including patients' psychological stress, immune biomarker changes, quality of life, and disease progression of patients towards secondary glioma after the first definite diagnosis. In the first year after diagnosis, patients are followed up four times at 1 month, 3 months, 6 months, and 12 months. After that, patients are followed up semiannually.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥18 years
Karnofsky Performance Score ≥ 70 %
histologically confirmed, previously untreated glioma receiving a standardized chemoradiotherapy regimen
no previous history of mental illness, drug abuse, or alcohol abuse
Disqualifiers
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.
Trial population
Adult patients with oligodendroglioma
Trial design
Cohort
Prospective
Treatments tested in this trial
Stressors
Other interventionPatients are exposed to stressful situations related to the diagnosis and treatment of the disease
Treatment groups
Trial outcomes
Primary outcomes
The proportion of patients with tumor recurrence
The proportion of patients with oligodendroglioma who had recurrence after tumor resection.
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.
Tumor mutation burden (TMB)
The proportion of tumor mutational burden ≥10 Mut/MB in the population who remain progression-free after diagnosis.
Secondary outcomes
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.
Progression-free survival at 5 years
The proportion of participants in the analysis population who remain progression-free for at least 5 years after diagnosis.
Overall survival rate at 8 years
OS-36 is the proportion of participants in the analysis population who remain alive for at least 8 years after diagnosis.
Progression-free survival at 8 years
The proportion of participants in the analysis population who remain progression-free for at least 8 years after diagnosis.
Other outcomes
Classification proportion of glioma recurrence
Patients with recurrent gliomas undergo secondary surgery/needle biopsy to determine the type of recurrent glioma.
Locations
Sponsors and contacts
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