NCT03005132

Brief Summary

Integrative analysis of GBM

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jan 2016Dec 2026

Study Start

First participant enrolled

January 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

10.9 years

First QC Date

December 23, 2016

Last Update Submit

December 23, 2016

Conditions

Keywords

GBM; Integrative Analysis; WES

Outcome Measures

Primary Outcomes (1)

  • 5 years overall survival

    5 years

Secondary Outcomes (3)

  • 5 years disease-free survival

    5 years

  • 10 years overall survival

    10 years

  • 10 years disease-free survival

    10 years

Study Arms (3)

Normal brain tissue

Normal brain tissue from GBM patients

Other: Normal brain tissue

GBM tissues

GBM tissues from GBM patients

Other: Normal brain tissue

Metastasis tissues

Metastasis tissues from GBM patients

Other: Normal brain tissue

Interventions

The investigators will extract total protein, DNA and RNA from the samples.

GBM tissuesMetastasis tissuesNormal brain tissue

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with GBM

You may qualify if:

  • 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

You may not qualify if:

  • Age ≥ 76
  • Severe major organ dysfunction
  • WHO performance status of \>1
  • Prior cancer chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Related 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. Epub 2015 Feb 4.

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Da Fu, PhD

    Shanghai 10th People's Hospital

    PRINCIPAL INVESTIGATOR
  • Xiaoming Zhong, MD

    Ganzhou City People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 23, 2016

First Posted

December 29, 2016

Study Start

January 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 29, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

The investigators are willing to share data.

Locations