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Correlation Between Psychological Stress and Progression of Diffuse Astrocytoma Towards Secondary Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05532969
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Henan Provincial People's Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Xingyao Bu
Principal Investigator Affiliation Henan Provincial People's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Astrocytoma
Additional Details

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.

Arms & Interventions

Arms

: Observation group of newly diffuse astrocytoma 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 diffuse astrocytoma 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

Interventions

Other: - stressors

Patients are exposed to stressful situations related to the diagnosis and treatment of the disease

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Henan Provincial People's Hospital, Zhengzhou, Henan, China

Status

Address

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003

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