Integrative Analysis of Human Glioblastoma Multiforme

• Sponsor: Shanghai 10th People's Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03005132
• Collaborator: Jilin University (Other), Ganzhou City People's Hospital (Other)
• Enrollment: 1,000
• Location: 1
• Duration (Months): 131
• Patients Per Site Per Month: 7.6

Study Details

Study Description

Brief Summary

Integrative analysis of GBM

Condition or Disease	Intervention/Treatment	Phase
GBM	Other: Normal brain tissue

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Integrative Analysis of Human Glioblastoma Multiforme
• Study Start Date: Jan 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2026
• Anticipated Study Completion Date: Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Normal brain tissue Normal brain tissue from GBM patients	Other: Normal brain tissue; The investigators will extract total protein, DNA and RNA from the samples.
GBM tissues GBM tissues from GBM patients	Other: Normal brain tissue; The investigators will extract total protein, DNA and RNA from the samples.
Metastasis tissues Metastasis tissues from GBM patients	Other: Normal brain tissue; The investigators will extract total protein, DNA and RNA from the samples.

Outcome Measures

Primary Outcome Measures

1. 5 years overall survival [5 years]

Secondary Outcome Measures

1. 5 years disease-free survival [5 years]

2. 10 years overall survival [10 years]

3. 10 years disease-free survival [10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Tenth People's Hospital	Shanghai	Shanghai	China	200072

Sponsors and Collaborators

• Shanghai 10th People's Hospital
• Jilin University
• Ganzhou City People's Hospital

Investigators

• Principal Investigator: Da Fu, PhD, Shanghai 10th People's Hospital
• Study Director: Xiaoming Zhong, MD, Ganzhou City People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Da Fu, Principal Investigator, Shanghai 10th People's Hospital
• ClinicalTrials.gov Identifier: NCT03005132
• Other Study ID Numbers: 2016-521-Rainy
• First Posted: Dec 29, 2016
• Last Update Posted: Dec 29, 2016
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Da Fu, Principal Investigator, Shanghai 10th People's Hospital: GBM; Integrative Analysis; WES
• Additional relevant MeSH terms: Glioblastoma

Study Results

No Results Posted as of Dec 29, 2016