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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.
Oligodendroglioma belongs to the class of gliomas that represent the most common class of primary malignant human brain tumors in adulthood. After tumor resection, patients still face the possibility of recurrence and even progression to glioblastoma. The immune microenvironment is most likely contributing to their development, but underlying pathomechanisms are only partly understood.
The high-level psychological stress can lead to a change in malignant tumors patients' neuroendocrine pathways and correlates with the prognosis outcome. In addition, psychological stress can lead to changes in the immune microenvironment, but if it leads to disease progression in oligodendroglioma towards secondary glioma has not been adequately demonstrated.
Grouping 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 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), and fear of disease progression scale (PoP-Q-SF).
Primary study objectives:
Secondary study objectives:
Exploratory objectives:
-To evaluate the effect of managing the patient's psychological stress on the patient's immune microenvironment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation group of newly oligodendroglioma patients with high-level psychological stress | The patients had high threshold levels of perceived psychological stress, fear, anxiety, and depression as assessed by psychologists |
| |
| Observation group of newly oligodendroglioma patients with low-level psychological stress | The patients had lower than threshold levels of perceived stress, psychological distress, fear, anxiety, and depression as assessed by psychologists |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stressors | Other | Patients are exposed to stressful situations related to the diagnosis and treatment of the disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with tumor recurrence | The proportion of patients with oligodendroglioma who had recurrence after tumor resection. | From the time of diagnosis to 8 years |
| 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 8 years |
| 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 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 8 years |
| Progression-free survival at 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Classification proportion of glioma recurrence | Patients with recurrent gliomas undergo secondary surgery/needle biopsy to determine the type of recurrent glioma. | From the time of diagnosis to 8 years |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients with oligodendroglioma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingyao Bu | Contact | +86037165580295 | xingyaobu@zzu.edu.cn | |
| Jie Mei | Contact | +8615188318262 | meijie@zzu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xingyao Bu | Henan Provincial People's Hospital | Study Director |
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| ID | Term |
|---|---|
| D009837 | Oligodendroglioma |
| D013315 | Stress, Psychological |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D000087602 | Anthropogenic Effects |
| ID | Term |
|---|---|
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
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The proportion of participants in the analysis population who remain progression-free for at least 5 years after diagnosis. |
| From the time of diagnosis to 8 years |
| 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. | From the time of diagnosis to 8 years |
| 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. | From the time of diagnosis to 8 years |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |