Integrative Analysis of Human Glioblastoma Multiforme

GBM Clinical Trial

Official title:

Integrative Analysis of Human Glioblastoma Multiforme

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03005132
• Other study ID #: 2016-521-Rainy
• Status: Recruiting
• Phase: N/A
• First received: December 23, 2016
• Last updated: December 23, 2016
• Start date: January 2016
• Est. completion date: December 2026

Study information

• Verified date: December 2016
• Source: Shanghai 10th People's Hospital
• Contact: Da Fu, PhD
• Phone: 00-86-21-66301604
• Email: fu800da900[@]126.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Observational

Clinical Trial Summary

Integrative analysis of GBM

Description:

The investigators will analyzed proteomes of paired normal brain tissues and GBM, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal brain tissue, primary GBM carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of GBM characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age = 75 years with histologically proven GBM

• No severe major organ dysfunction

• World Health Organization (WHO) performance status of 0 or 1

• No prior cancer chemotherapy

Exclusion Criteria:

• Age = 76

• Severe major organ dysfunction

• WHO performance status of >1

• Prior cancer chemotherapy

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• GBM
• Glioblastoma

Intervention

Other:
• Normal brain tissue
The investigators will extract total protein, DNA and RNA from the samples.

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital	Ganzhou City People's Hospital, Jilin University

Country where clinical trial is conducted

China, 

References & Publications (1)

Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5 years overall survival		5 years	Yes
Secondary	5 years disease-free survival		5 years	Yes
Secondary	10 years overall survival		10 years	Yes
Secondary	10 years disease-free survival		10 years	Yes