AstrocytomaNCT05532969
Correlation Between Psychological Stress and Progression of Diffuse Astrocytoma Towards Secondary Glioma
An observational study of Astrocytoma, run by Henan Provincial People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Astrocytoma
- What is being tested?
- stressors
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2022to 20 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Adult patients with diffuse astroglioma
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Correlation Between Psychological Stress and Progression of Diffuse Astrocytoma Towards Secondary Glioma: a Longitudinal Study Based on Long-term Follow-up
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.
Read the 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.
- Conditions
- Astrocytoma
- Being tested
- stressors
- Keywords
- Astrocytoma, Psychological stress, progression
- Medical subject headings
- Astrocytoma, Stress, Psychological, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stressorsOther
Patients are exposed to stressful situations related to the diagnosis and treatment of the disease
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: stressors | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with tumor recurrence
The proportion of patients with diffuse astroglioma who had recurrence after tumor resection.
Measured: 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.
Measured: 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.
Measured: From the time of diagnosis to 8 years
Secondary outcomes (4)
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.
Measured: From the time of diagnosis to 8 years
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.
Measured: 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.
Measured: 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.
Measured: From the time of diagnosis to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start20 Dec 2022 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstrocytomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xingyao Bu, Study director, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532969
- Sponsor's protocol ID
- HenanPPH-astrocytoma
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Psychological Stress and Progression of Diffuse Astrocytoma Towards Secondary Glioma: a Longitudinal Study Based on Long-term Follow-up
- ClinicalTrials.gov ID
- NCT05532969
- Acronym / sponsor ID
- HenanPPH-astrocytoma
- Conditions
- Astrocytoma
- Keywords
- Astrocytoma, Psychological stress, progression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation group of newly diffuse astrocytoma patients with high-level psychological stress | – | Other: stressorsThe 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with diffuse astroglioma
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stressorsPatients are exposed to stressful situations related to the diagnosis and treatment of the disease | Other | Observation group of newly diffuse astrocytoma patients with high-level psychological stress |
Primary outcome
The proportion of patients with tumor recurrence
Time frame: From the time of diagnosis to 8 years
The proportion of patients with diffuse astroglioma who had recurrence after tumor resection.
The proportion of patients with high-level psychological stress
Time frame: From the time of diagnosis to 8 years
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)
Time frame: From the time of diagnosis to 8 years
The proportion of tumor mutational burden ≥10 Mut/MB in the population who remain progression-free after diagnosis.
4 secondary outcomes
The Short Form-36 (SF-36)
Time frame: From the time of diagnosis to 8 years
Progression-free survival at 5 years
Time frame: From the time of diagnosis to 8 years
Overall survival rate at 8 years
Time frame: From the time of diagnosis to 8 years
Progression-free survival at 8 years
Time frame: From the time of diagnosis to 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xingyao Bu study director
Henan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Astrocytoma, run by Henan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingyao Bu (+86037165580295, xingyaobu@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with tumor recurrence (time frame: From the time of diagnosis to 8 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.