Immune and Inflammatory Indices in Peripheral Blood Predict Prognosis of Glioma and Correlate With Grades and Subtypes

Preoperative Immune and Inflammatory Indices in Peripheral Blood Predict Prognosis of Glioma and Correlate With Grades and Subtypes: A Prospective Multi-Institutional Study

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.

Study Overview

• Status: Recruiting
• Conditions: Glioma; Immune Suppression
• Intervention / Treatment: Other: Detection of Immune and Inflammatory Indices in Peripheral Blood

• Study Type: Observational
• Enrollment (Estimated): 1282

Contacts and Locations

• Study Contact: Name: Sheng Zhong, M.D.; Phone Number: 18743037749; Email: zhongsheng@sysucc.org.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 10000
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Ye Cheng, M.D.; Phone Number: 18344560369; Email: 947145386@qq.com
  • Guangdong
    • Guanzhou, Guangdong, China, 510000
      • Completed
      • Sun Yat-sen University Cancer Center
  • Jilin
    • Chang chun, Jilin, China, 130000
      • Recruiting
      • The First Bethune Hospital of Jilin University
      • Contact: Zhiyun Zhang, M.M.; Phone Number: 15506015535; Email: 893554380@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
primary glioma patients; We collected the information of clinical characteristics, inflammatory factors and immune factors of patients with primary glioma.	Other: Detection of Immune and Inflammatory Indices in Peripheral Blood; We detected immune and inflammatory indices in peripheral blood at each patient's at first hospitalizatin from October 13th, 2006, to April 6th, 2022.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality	For this study, the endpoint was all-cause mortality. Time zero was set at the time of resection of the primary tumor.	16 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2006
• Primary Completion (Actual): April 6, 2022
• Study Completion (Estimated): December 20, 2023

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: ShengZhong

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No