NCT05635435

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2006

Completed
15.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

15.5 years

First QC Date

November 21, 2022

Last Update Submit

July 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

We detected immune and inflammatory indices in peripheral blood at each patient's at first hospitalizatin from October 13th, 2006, to April 6th, 2022.

primary glioma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 10000, China

RECRUITING

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, 510000, China

COMPLETED

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Central Study Contacts

Sheng Zhong, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 2, 2022

Study Start

October 13, 2006

Primary Completion

April 6, 2022

Study Completion

December 20, 2023

Last Updated

July 12, 2023

Record last verified: 2023-07

Locations