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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03005132
Other study ID # 2016-521-Rainy
Secondary ID
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


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
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