Integrative Analysis of Human Glioblastoma Multiforme

December 23, 2016 updated by: Da Fu, Shanghai 10th People's Hospital
Integrative analysis of GBM

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Recruiting
        • Shanghai Tenth People's Hospital
        • Contact:
        • Principal Investigator:
          • Yushui Ma, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with GBM

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
5 years overall survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
5 years disease-free survival
Time Frame: 5 years
5 years
10 years overall survival
Time Frame: 10 years
10 years
10 years disease-free survival
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2026

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

December 23, 2016

First Submitted That Met QC Criteria

December 23, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Estimate)

December 29, 2016

Last Update Submitted That Met QC Criteria

December 23, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-521-Rainy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators are willing to share data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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