GliomaNCT05635435
Immune and Inflammatory Indices in Peripheral Blood Predict Prognosis of Glioma and Correlate With Grades and Subtypes
An observational study of Glioma and Immune Suppression, run by Sun Yat-sen University at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Immune Suppression
- What is being tested?
- Detection of Immune and Inflammatory Indices in Peripheral Blood
- How many people
- 1,282 participants
- Where
- 3 sitesChina
- Study dates
- 13 Oct 2006to 20 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 2 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 10000
Ye Cheng, M.D., 18344560369, 947145386@qq.com
- Recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130000
Zhiyun Zhang, M.M., 15506015535, 893554380@qq.com
- Completed
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, 510000
About this study
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
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.
- Conditions
- Glioma, Immune Suppression
- Being tested
- Detection of Immune and Inflammatory Indices in Peripheral Blood
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of Immune and Inflammatory Indices in Peripheral BloodOther
We detected immune and inflammatory indices in peripheral blood at each patient's at first hospitalizatin from October 13th, 2006, to April 6th, 2022.
| Study group | Role | What they receive |
|---|---|---|
| primary glioma patients | We collected the information of clinical characteristics, inflammatory factors and immune factors of patients with primary glioma. Receives: Other: Detection of Immune and Inflammatory Indices in Peripheral Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start13 Oct 2006
- Primary completion6 Apr 2022
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonggao Mou, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635435
- Sponsor's protocol ID
- ShengZhong
- Status last verified
- Jul 2023
- First submitted
- 21 Nov 2022
- Last updated
- 12 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05635435
- Acronym / sponsor ID
- ShengZhong
- Conditions
- Glioma, Immune Suppression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,282 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 13 Oct 2006 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| primary glioma patients | – | Other: Detection of Immune and Inflammatory Indices in Peripheral BloodWe collected the information of clinical characteristics, inflammatory factors and immune factors of patients with primary glioma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of Immune and Inflammatory Indices in Peripheral BloodWe detected immune and inflammatory indices in peripheral blood at each patient's at first hospitalizatin from October 13th, 2006, to April 6th, 2022. | Other | primary glioma patients |
Primary outcome
all-cause mortality
Time frame: 16 years
For this study, the endpoint was all-cause mortality. Time zero was set at the time of resection of the primary tumor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma and Immune Suppression, run by Sun Yat-sen University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng Zhong, M.D. (18743037749, zhongsheng@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 16 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.