Correlation Between Psychological Stress and Progression of Newly Oligodendroglioma Towards Secondary Glioma

Oligodendroglioma, Adult Clinical Trial

Official title:

Correlation Between Psychological Stress and Progression of Newly Oligodendroglioma Towards Secondary Glioma: A Longitudinal Study Based on Long-term Follow-up

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05536986
• Other study ID #: HenanPPH-Oligodendroglioma
• Status: Not yet recruiting
• Start date: December 20, 2022
• Est. completion date: December 20, 2030

Study information

• Verified date: September 2022
• Source: Henan Provincial People's Hospital
• Contact: Xingyao Bu
• Phone: +86037165580295
• Email: xingyaobu[@]zzu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

• 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 oligodendroglioma 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 20, 2030
• Est. primary completion date: December 20, 2028
• 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 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.

Related Conditions & MeSH terms

• Disease Progression
• Oligodendroglioma
• Oligodendroglioma, Adult
• Stress, Psychological

Intervention

Other:
• Stressors
Patients are exposed to stressful situations related to the diagnosis and treatment of the disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henan Provincial People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
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 8 years
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 8 years
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 8 years
Secondary	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.	From the time of diagnosis to 8 years
Secondary	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
Secondary	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