Clinical trial NCT05532969: Correlation Between Psychological Stress and Progression of Diffuse Astrocytoma Towards Secondary Glioma
Official title: Correlation Between Psychological Stress and Progression of Diffuse Astrocytoma Towards Secondary Glioma: a Longitudinal Study Based on Long-term Follow-up
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Astrocytoma
Keywords: Astrocytoma
Psychological stress
progression
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with diffuse astroglioma

Brief summary: It is a single-center, prospective, observational, non-randomized study of newly diagnosed diffuse astrocytoma 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.

Detailed description: Diffuse astrocytomas belong 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 diffuse astrocytoma 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), VAS stress, and fear of disease progression scale (PoP-Q-SF).

Primary study objectives:

* To evaluate the proportion of patients with tumor recurrence
* To evaluate the changes in immune markers of acute and chronic psychological stress in patients with diffuse astrocytoma after diagnosis.
* To analyze the classification of recurrent glioma.

Secondary study objectives:

* To evaluate the progression-free survival of patients with different psychological stress levels.
* To evaluate the overall survival of patients with different psychological stress levels.
* To evaluate the quality of life of patients with different psychological stress levels.

Exploratory objectives:

• To evaluate the effect of managing the patient's psychological stress on the patient's immune microenvironment.

Eligibility criteria: Inclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: The proportion of patients with tumor recurrence
timeFrame: From the time of diagnosis to 8 years
measure: The proportion of patients with high-level psychological stress
timeFrame: From the time of diagnosis to 8 years
measure: Tumor mutation burden (TMB)
timeFrame: From the time of diagnosis to 8 years
Secondary outcomes:
measure: The Short Form-36 (SF-36)
timeFrame: From the time of diagnosis to 8 years
measure: Progression-free survival at 5 years
timeFrame: From the time of diagnosis to 8 years
measure: Overall survival rate at 8 years
timeFrame: From the time of diagnosis to 8 years
measure: Progression-free survival at 8 years
timeFrame: From the time of diagnosis to 8 years
Other outcomes:
measure: Classification proportion of glioma recurrence
timeFrame: From the time of diagnosis to 8 years
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
Study officials:
affiliation: Henan Provincial People's Hospital
name: Xingyao Bu
role: STUDY_DIRECTOR
References: