Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05515133
Other study ID # HenanPPH-Glioma
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 15, 2022
Est. completion date December 31, 2025

Study information

Verified date August 2022
Source Henan Provincial People's Hospital
Contact Xingyao Bu, PhD
Phone +86037165580295
Email xingyaobu@zzu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

It is a single-center, prospective, observational,non-randomized study of newly diagnosed glioblastoma patients conducted in a tertiary hospital. The investigators examine the psychological stress, immune biomarker changes, quality of life, and disease progression of patients with glioblastoma at five-time points. 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:

Glioblastoma (GBM) is the most common and aggressive primary malignant brain tumor affecting adults, with a median survival of 12-16 months after diagnosis. The diagnosis of a malignant tumor has a huge impact on patients' psychology, which is easy to lead to patients in a state of stress. The high-stress level can lead to a change in patients' health behaviors and correlates with the prognosis outcome. In addition, psychological stress can lead to changes in the immune microenvironment, but disease progression and quality of life in glioblastoma have 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 recceive 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 changes in immune markers of acute and chronic psychological stress in patients with glioblastoma after diagnosis. Secondary study objectives: - To evaluate the quality of life of patients with different psychological stress levels. - To evaluate the progression-free survival 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. - To evaluate the incidence of mental illness. - To evaluate the patient treatment compliance.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 31, 2025
Est. primary completion date August 15, 2024
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 GBM - 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Henan Provincial People's Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Henan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Overall survival rate at 12 months OS-12 is the proportion of participants in the analysis population who remain alive for at least twelve months after diagnosis. From the time of diagnosis to 12 months
Other Progression-free survival Median time from allocation to first documented disease progression as per RANO or death due to any cause, whichever occurs first. Up to 3 years after diagnosis
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 12 months
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 12 months
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 12 months
Secondary Progression-free survival at 6 months The proportion of participants in the analysis population who remain progression-free for at least six months after diagnosis. From the time of diagnosis to 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05664243 - A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma Phase 1/Phase 2
Completed NCT02768389 - Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma Early Phase 1
Recruiting NCT05635734 - Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma Phase 1/Phase 2
Completed NCT03679754 - Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102 Phase 1
Completed NCT01250470 - Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma Phase 1
Terminated NCT03927222 - Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma Phase 2
Recruiting NCT03897491 - PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma Phase 2
Active, not recruiting NCT03587038 - OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma Phase 1
Completed NCT01922076 - Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas Phase 1
Recruiting NCT04391062 - Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma Phase 2
Active, not recruiting NCT03661723 - Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma Phase 2
Active, not recruiting NCT02655601 - Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 Phase 2
Completed NCT02206230 - Trial of Hypofractionated Radiation Therapy for Glioblastoma Phase 2
Completed NCT03493932 - Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade Phase 1
Terminated NCT02709889 - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06058988 - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer Phase 2
Completed NCT03018288 - Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM) Phase 2
Withdrawn NCT03980249 - Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells Early Phase 1
Not yet recruiting NCT04552977 - A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma Phase 2
Withdrawn NCT02876003 - Efficacy and Safety of G-202 in PSMA-Positive Glioblastoma Phase 2