Methylation Patterns of the NUPR1, MGMT, NDRG2, and GLI1 Genes and Their Impact on Therapeutic Outcome of GBM Patients

NCT06538428 | Completed DMC

• 1 other identifier: ENREC-ASU 2020-8
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

GBM

Outcome Measures

Primary Outcomes (1)

• GBM prognosis

  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 \[temozolomide\].

  two years

Secondary Outcomes (1)

• Survival analysis

  two years

Study Arms (2)

GBM group

58 primary GBM treatment-naïve Egyptian patients DNA methylation profiling for four genes (MGMT, NUPR1,NDRG2,and GLI1 gene) using EpiTect Methyl II (qPCR) system (Qiagen, Germany).

Genetic: DNA methylation profiling

NND group

DNA methylation profiling for four genes (MGMT, NUPR1,NDRG2,and GLI1 gene) using EpiTect Methyl II (qPCR) system (Qiagen, Germany).

Genetic: DNA methylation profiling

Interventions

DNA methylation profiling GENETIC

measurement of methylation levels of MGMT, NUPR1,NDRG2,and GLI1 gene

GBM group; NND group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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. The NND group comprised 20 sex-matched individuals recruited randomly. The age ranged from 4 to 54 years old, with an equal male-to-female ratio of 10 to 10. Those who were not receiving any medications or suffering from any current or past malignancy.

You may qualify if:

• 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

You may not qualify if:

• Other types of cancer,
• HBV
• HCV
• Schistosomiasis
• HCC
• HIV
• Alcohol intake
• Thyroid dysfunction
• Inflammatory diseases
• Cerebrovascular disorders

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university hospital

Cairo, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

During maximum safe surgical resection, tumor specimens were surgically retrieved using open stereotactic biopsy technique then preserved in neutral buffered formalin and wrapped in paraffin stained with hematoxylin-eosin (HE).

Study Officials

• Nadia Hamdy, PhD

  Professor of Biochemistry, Biochemistry Dept., Faculty of Pharmacy, ASU

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: August 5, 2024
• Study Start: September 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 9, 2022
• Last Updated: August 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)