Study on Gene Evolution in Glioma Under Stress Therapy

ConditionGenetic Change

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-75

SponsorHenan Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years, both male and female (including 18 and 75 years old) glioma;

Willing to accept treatment and sign informed consent.

Disqualifiers

Participants with other infection disease or immunodeficiency disease;

other central infectious diseases;

malignant tumor of non-nervous system;

drug abuse;

Trial population

Age 18 to 75 years, both male and female (including 18 and 75 years old) glioma; Willing to accept treatment and sign informed consent.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Gene evolution and molecular response under Bevacizumab treatment
Drug
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

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Gene evolution of glioma in vivo0 interventions

Group B: Gene evolution and molecular response under Bevacizumab treatment1 intervention

Trial outcomes

Primary outcomes

Different subtypes of glioma have different therapeutic responses to bevacizumab

We evaluated the efficacy of bevacizumab on different subtypes of glioma at recurrence according to delta-VAF and Ratio combined with imaging.The mean change in VAF (delta-VAF) was calculated per patient as the sum of the ontreatmentVAF minus the pretreatment VAF for each detected SNV or indel divided by the number of detected SNVs or indels, we found that the "molecular responce" model could generally be represented in simpler terms through a ratio of ontreatment VAF to pretreatment VAF

Time frame

96 weeks

the molecular mechanism of bevacizumab resistance in vivo.

We compared and analyzed the genes before and after bevacizumab treatment according to the gene evolution of ctDNA.To clarify the molecular mechanism of bevacizumab resistance.

Time frame

144 weeks

Sponsors and contacts

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Henan Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov

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