Clinical trial NCT05635435: Immune and Inflammatory Indices in Peripheral Blood Predict Prognosis of Glioma and Correlate With Grades and Subtypes
Official title: Preoperative Immune and Inflammatory Indices in Peripheral Blood Predict Prognosis of Glioma and Correlate With Grades and Subtypes: A Prospective Multi-Institutional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioma
Immune Suppression
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 1282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility 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;

Primary outcomes:
measure: all-cause mortality
timeFrame: 16 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Guanzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Chang chun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
Study officials:
References: