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Study on Gene Evolution in Glioma Under Stress Therapy
25 september 2022 bijgewerkt door: Henan Provincial People's Hospital
Study on Gene Evolution and Anti-VEGF Treatment Response of Different Subtypes of Glioma Based on ctDNA
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Verwacht)
100
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Xingyao Bu, Ph.D
- Telefoonnummer: 18538297990
- E-mail: xingyaob@zzu.edu.cn
Studie Contact Back-up
- Naam: Huibin Ning, Ph.D
- Telefoonnummer: 15981849054
- E-mail: situhailuo@163.com
Studie Locaties
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Henan
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Zhengzhou, Henan, China, 450003
- Henan Provincial People's Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Age 18 to 75 years, both male and female (including 18 and 75 years old) glioma; Willing to accept treatment and sign informed consent.
Beschrijving
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;
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
Gene evolution of glioma in vivo
Group A: gene evolution with relapsed.
From the first day after the operation, the ctDNA was extracted from TISF before concurrent chemoradiotherapy as the baseline, and then the ctDNA was detected again after concurrent chemoradiotherapy.
For the third time, ctDNA was detected in intensive chemotherapy with temozolomide.
The image showed that the tumor progress was detected for the fourth time, and the ctDNA was detected for the fifth time when the tumor recurred.
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,
|
|
Gene evolution and molecular response under Bevacizumab treatment
After the recurrence, temozolomide combined with bevacizumab was used for chemotherapy, After bevacizumab was applied after six week , ctDNA is tested every six weeks.
temozolomide combined with bevacizumab (600mg) in the course of tumor progression once a month.
|
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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Different subtypes of glioma have different therapeutic responses to bevacizumab
Tijdsspanne: 96 weeks
|
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
|
96 weeks
|
the molecular mechanism of bevacizumab resistance in vivo.
Tijdsspanne: 144 weeks
|
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.
|
144 weeks
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Verwacht)
17 december 2022
Primaire voltooiing (Verwacht)
31 december 2025
Studie voltooiing (Verwacht)
31 december 2026
Studieregistratiedata
Eerst ingediend
21 augustus 2022
Eerst ingediend dat voldeed aan de QC-criteria
21 augustus 2022
Eerst geplaatst (Werkelijk)
23 augustus 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 september 2022
Laatste update ingediend die voldeed aan QC-criteria
25 september 2022
Laatst geverifieerd
1 augustus 2022
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata, glandulair en epitheel
- Neoplasmata, neuro-epitheliaal
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Glioom
- Fysiologische effecten van medicijnen
- Antineoplastische middelen
- Antineoplastische middelen, immunologisch
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Bevacizumab
Andere studie-ID-nummers
- HenanPPH-GRS
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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