Skip to content

Clinical application of fluid biopsy of exosomes of gliomas based on multicenter cross group design

Clinical application of fluid biopsy of exosomes of gliomas based on multicenter cross group design

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000033164
Enrollment
Unknown
Registered
2020-05-22
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

Interventions

Gold Standard:Pathological diagnosis
and&#32
serum&#32

Sponsors

Qilu hospital Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Fluid biopsy cohort for early diagnosis of gliomas: 1. For all 20-69-year-old outpatients in the multicenter cohort who had "imaging findings of early space occupying lesions in brain parenchyma", as the hematology biopsy group, the patients signed informed consent; improved MRI plain scan + enhanced examination and Mrs spectrum analysis, and retained the original image data in the format of DICM; collected the venous blood of patients for serum separation and exosomes separation and purification; no other tumors Related diseases and medical history; fasting, fasting and not taking drugs for more than 12 hours at the time of blood collection, but not receiving any treatment; clinical baseline data were collected, filed and registered for follow-up; 2. Recruit some patients in the above cohort as CSF biopsy group: patients can accept lumbar puncture and sign informed consent; collect CSF of patients for exocrine body separation and purification; patients with contraindications of lumbar puncture need to be excluded; other requirements are the same as those of Hematology biopsy group; 3. Randomly select the glioma patients in neurosurgery as the glioma control group: randomly select the patients whose age, gender and location match and who have informed consent from the patients who have not been confirmed clinically in the hospital according to the proportion of 1:1, and finally confirmed by the postoperative pathology; 4. Randomly selected patients with benign intracranial tumor in neurosurgery as benign tumor control group: randomly selected patients with age, gender, location matching and informed consent from meningioma, pituitary tumor, acoustic neuroma and other patients who were not clinically confirmed in the hospital according to the proportion of 1:1; 5. Randomly select the patients in neurology and surgery as non-tumor control group: randomly select the non-tumor patients such as hydrocephalus, central nervous system inflammation and so on, who are matched in age, gender, location and informed consent. Liquid biopsy cohort for glioblastoma recurrence monitoring: all 20-69-year-old patients with glioblastoma undergoing neurosurgery in the multicenter cohort were randomly assigned to the liquid biopsy group and the control group. Liquid biopsy group: 1. Patients sign informed consent; 2. Before the operation, the MRI plain scan, enhanced examination and Mrs spectrum analysis were completed, and the original image data of DICM format were retained; 3. The venous blood of patients was collected before operation, and the serum and exosomes were separated and purified; 4. No other tumor related diseases and history; 5. Before the operation, the patients received lumbar puncture, collected CSF, and purified exosomes; 6. The contraindications of lumbar puncture should be excluded; 7. Glioblastoma was confirmed by pathology; 8. Cerebrospinal fluid and blood samples of each follow-up time node were collected and exosomes were extracted according to the flow of fluid biopsy; 9. In the follow-up process, patients with recurrence indicated by liquid biopsy will enter the recurrence monitoring process, including MRI examination with higher frequency, Mrs spectrum examination of early recurrence and treatment of precise radiotherapy (such as gamma knife). After treatment, the routine follow-up process will be continued, while patients with recurrence found but not indicated by liquid biopsy will be treated by observation and

Exclusion criteria

Exclusion criteria: Fluid biopsy cohort for early diagnosis of gliomas: 1. Patients who have not signed the informed consent; 2. The patients who did not complete MRI plain scan, enhanced examination and Mrs spectrum analysis at the first diagnosis and retained the original DICM format image data; 3. Patients with other tumor related diseases and history; 4. Patients who have received surgery and other treatment and patients with recurrence; 5. Patients who failed to obtain blood and cerebrospinal fluid samples at the first diagnosis. Liquid biopsy cohort for glioblastoma recurrence monitoring: 1. Patients who have not signed the informed consent; 2. The patients who did not complete MRI plain scan, enhanced examination and Mrs spectrum analysis at the first diagnosis and retained the original DICM format image data; 3. Patients with other tumor related diseases and history; 4. The patients were not glioblastoma confirmed by pathology; 5. Patients who have received surgery and other treatment at the first diagnosis and patients who have relapsed.

Design outcomes

Primary

MeasureTime frame
glioma RNA;CSF exosomal RNA;Serum exosomal RNA;

Countries

China

Contacts

Public ContactLi Gang

Qilu Hospital of Shandong University

dr.ligang@sdu.edu.cn+86 13606373098

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026