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Trial Title:
Study on Gene Evolution in Glioma Under Stress Therapy
NCT ID:
NCT05512325
Condition:
Genetic Change
Conditions: Official terms:
Glioma
Bevacizumab
Conditions: Keywords:
gene evolution, ctDNA, molecular response, Bevacizumab
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Gene evolution and molecular response under Bevacizumab treatment
Description:
Patients with glioma were routinely treated with temozolomide chemotherapy from the 4th
week after operation, for 5 days continuously, once every 4 weeks, with a single dose as
follows: Single dose = BSA (body surface area) * 150mg/m2/day BSA(Body Surface
Area)=[weight (kg)* height (cm)/3600]2, According to the molecular pathological grade
(WHO CNS5 grade), it is decided whether to combine radiotherapy (GBM combined with
radiotherapy) and temozolomide combined with bevacizumab (600mg) in the course of tumor
progression, Recording image changes
Arm group label:
Gene evolution and molecular response under Bevacizumab treatment
Summary:
Little is known about the evolution of genetic and epigenetic changes that occur in the
progression of glioma. We inferred the evolution trajectories of matched pairs of primary
tumors and progression tumor in situ fluid (TISF) based on deep whole-genome-sequencing
data (ctDNA). A monocentric, Gene grouping controlled trial design was used to select
patients. and to compare gene evolution of different subtypes of glioma under therapy. To
predict the molecular reaction of bevacizumab treatment, clarify the mechanism of drug
resistance of bevacizumab treatment.
Detailed description:
Patient: Adult glioma, pathological diagnosis combined with molecular diagnosis (i.e.
IDH- mutant glioma, IDH- mutant glioma with 1p/19q- co-deletion, glioblastoma). The
patients were divided into three groups: group A (IDH mutant glioma), group B (IDH mutant
with 1p/19q co-deletion oligodendroglioma ) and group C (IDH wild glioblastoma). From the
first day after surgery, the ctDNA was extracted with TISF before concurrent
chemoradiotherapy as the baseline, and the ctDNA was detected again after concurrent
chemoradiotherapy. For the third time, ctDNA was detected in temozolomide intensive
chemotherapy. ctDNA was detected for the fourth time when the image showed tumor
progression. After the progress, temozolomide combined with bevacizumab was used for
chemotherapy. ctDNA was detected 6 weeks after the application of bevacizumab, and ctDNA
was re-measured every 6 weeks during the treatment of bevacizumab. At the same time,
imaging examination was performed to determine the tumor progress. Check and record
adverse events and drug use in detail, and evaluate the compliance of subjects; After
TISF tissue extraction, the retained blood samples were sent to simcere Company and
Beijing Genetron Health Technology Co. Ltd for ctDNA quantification and detection. To
study the differences of gene evolution of different subtypes of glioma under pressure
therapy, to clarify the differences of molecular responses of different subtypes of
glioma to bevacizumab, and to evaluate the therapeutic effect and safety.
Criteria for eligibility:
Study pop:
Age 18 to 75 years, both male and female (including 18 and 75 years old) glioma; Willing
to accept treatment and sign informed consent.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Age 18 to 75 years, both male and female (including 18 and 75 years old) glioma;
- Willing to accept treatment and sign informed consent.
Exclusion Criteria:
- Participants with other infection disease or immunodeficiency disease;
- other central infectious diseases;
- malignant tumor of non-nervous system;
- drug abuse;
- severe psychiatric disease;
- uncontrolled diabetes;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Provincial People's Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Contact:
Last name:
Xingyao Bu
Email:
xingyaob@zzu.edu.cn
Start date:
December 17, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Henan Provincial People's Hospital
Agency class:
Other
Source:
Henan Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05512325
