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

Glioma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05635435
• Other study ID #: ShengZhong
• Status: Recruiting
• Start date: October 13, 2006
• Est. completion date: December 20, 2023

Study information

• Verified date: July 2023
• Source: Sun Yat-sen University
• Contact: Sheng Zhong, M.D.
• Phone: 18743037749
• Email: zhongsheng[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1282
• Est. completion date: December 20, 2023
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Glioma
• Immune Suppression

Intervention

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.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing
China	The First Bethune Hospital of Jilin University	Chang chun	Jilin
China	Sun Yat-sen University Cancer Center	Guanzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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