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临床试验/NCT06538428
NCT06538428已完成不适用

Studying Some Epigenetic Modifications In Glioblastoma Multiforme and Their Impact On Clinical Outcome

Ain Shams University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
GBM prognosis

研究概览

简要总结

The study aimed to investigate the role of promoter methylation of MGMT, NUPR1, NDRG2, and GLI1 genes in glioblastoma multiforme (GBM) patients. Tissue samples were collected from GBM patients and individuals with non-neurooncological diseases (NND). The methylation status of the four genes was analyzed, and the clinical characteristics and survival of GBM patients were evaluated.

详细描述

Objectives. Elucidate the potential role of methylation levels of the MGMT, NUPR1, NDRG2, and GLI1 genes as epigenetic markers for GBM through measuring and comparing the methylation levels of four genes in GBM and NND samples The study researchers started recruiting participants from September 2020 to October 2022, after receiving research ethical approvals from the Medical Ethical Committees at the National Research Center ID#20110 and from the Research Ethics Committee of Faculty of Pharmacy, Ain Shams University, Cairo, Egypt, serial no.[ENREC-ASU 2020-8].

Informed consents were signed by patients or their first-degree relatives. Study participants either patients or controls were informed with the study problem, aim, and objectives. The study was conducted in accordance with the Declaration of Helsinki Guidelines approved in 2013.

A total of 58 primary GBM treatment-naïve Egyptian patients were recruited from the Clinical Oncology Department, Faculty of Medicine, Ain Shams University Hospital, Cairo, Egypt.

Patients' Inclusion Criteria Adult patients (age > 18 years) with a recent diagnosis of GBM and had a performance level of less than or equal to 2 on the Ester Clinical Oncology Group (ECOG) scale .

Therapeutic Approaches, All GBM patients were evaluated clinically, through a full medical history, physical, and neurological examinations. Brain scan was done to enable the patient to receive standardized therapeutic protocol, which includes the greatest secured surgical removal (if attainable), followed by conventional fractionated radiotherapy (aggregate dosage of 60 gray (Gy), provided 2 Gy per fraction for 30 fractions during six weeks) or hypo-fractionated radiotherapy (45 Gy in 15 fractions during three weeks) alongside concurrent TMZ as chemotherapeutic agent in dose of 75 mg/m2 of body surface area daily until the completion of the radiation therapy with periodical follow-up, then re-evaluated clinically and radiologically, given an adjuvant therapy at total of six cycles of TMZ therapy at a dosage of 150 mg/m2 of body surface area from day one to five for a total of 28 days with closely medical surveillance.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (age > 18 years)
  • Recent diagnosis of GBM
  • Performance status of less than or equal to 2 on the Ester Clinical Oncology Group
  • (ECOG) scale,1)
  • Pathologically proven GBM

排除标准

  • Other types of cancer,
  • Schistosomiasis
  • Alcohol intake
  • Thyroid dysfunction
  • Inflammatory diseases
  • Cerebrovascular disorders

结局指标

主要结局

GBM prognosis

时间窗: two years

Determine the prognostic and predictive significance of the DNA methylation patterns of the examined genes in Egyptian GBM patients. Using the EpiTect Methyl II PCR Kit, The methylation levels of four genes: MGMT, NUPR1, NDRG2, and GLI1 were measured. Then, using Spearman correlation, their levels were correlated with GBM progression and therapeutic response to the chemotherapeutic drug \[temozolomide\].

次要结局

  • Survival analysis(two years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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