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Trial Title:
Immune and Inflammatory Indices in Peripheral Blood Predict Prognosis of Glioma and Correlate With Grades and Subtypes
NCT ID:
NCT05635435
Condition:
Glioma
Immune Suppression
Conditions: Official terms:
Glioma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Detection of Immune and Inflammatory Indices in Peripheral Blood
Description:
We detected immune and inflammatory indices in peripheral blood at each patient's at
first hospitalizatin from October 13th, 2006, to April 6th, 2022.
Arm group label:
primary glioma patients
Summary:
Our study considered the relevant immune and inflammatory indices, such as immunoglobulin
kappa light chain, TNF, and CD4+ Helper T lymphocyte% in a multi-institutional study with
a large patient cohort (n=1282) from the east, northeast, and southeast of China. Our
study shed light on the association of peripheral immune system status with prognosis,
tumor grade, and subtype of glioma, which can potentially benefit future diagnostic and
prognostic processes of glioma given its noninvasive nature. Moreover, the preoperative
inflammatory status can be leveraged for timely interventions to reverse the
immunosuppressive status of cancer patients and enhance anti-tumour immunity of glioma.
Criteria for eligibility:
Study pop:
In our cohort, there were more males (count, 761, percentage, 59.39%) than females. In
addition, 762 patients (percentage, 59.4%) were diagnosed as grade IV glioma according to
2021 WHO criteria, which was far more than the other grades in our study. Similar
characteristics were observed in the glioma subtype. IDH1 mutation status, 1p/19q
codeletion status and MGMT promoter methylation status were known in 924, 771, and 855
patients, respectively. Among them, 630 of 924 patients were IDH1 mutant type, 124 of 771
patients had 1p/19q codeletion, and 369 of 855 patients were MGMT methylated. In
addition, 916 patients received chemotherapy within one month after the resection of
primary glioma, while 940 patients received radiotherapy postoperatively.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- glioma grading and classification histologically verified in a resection or biopsy
specimen according to 2016 WHO criteria;
- age > 18 years;
- primary malignant glioma;
- the duration of follow-up > 3 months;
- available data of lymphocyte subsets, cytokines, immune proteins and immune
complements measured at the patient's first hospitalization.
Exculsion Criteria:
- current infectious disease, hyperpyrexia, hematological disease, diabetes mellitus,
serious heart disease, hypertension, metabolic syndrome, severe renal or hepatic
dysfunction, other cancer, autoimmune disease, inflammatory disease, or medication
usage related to an inflammatory condition;
- prior cancer-specific pretreatment, such as chemotherapy or radiotherapy;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Xuanwu Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
10000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ye Cheng, M.D.
Phone:
18344560369
Email:
947145386@qq.com
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guanzhou
Zip:
510000
Country:
China
Status:
Completed
Facility:
Name:
The First Bethune Hospital of Jilin University
Address:
City:
Chang chun
Zip:
130000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiyun Zhang, M.M.
Phone:
15506015535
Email:
893554380@qq.com
Start date:
October 13, 2006
Completion date:
December 20, 2023
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05635435
