NCT03152708

Brief Summary

This study was conducted on the post-operative tumor tissues from 62 GBM patients. 20 slices are necessary for all the CD95 and CpG2 test in the central lab by the methods of immunisation and DNA methylation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

May 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

September 21, 2017

Status Verified

September 1, 2017

Enrollment Period

1 month

First QC Date

May 11, 2017

Last Update Submit

September 20, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • CD95 Ligand Positive Rate

    0 day

Secondary Outcomes (1)

  • CpG2 Positive Rate

    0 day

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese GBM patients

You may qualify if:

  • Chinese nationality
  • No limits on Gender and age
  • First diagnosed GBM
  • Brain tumor tissue cytological diagnosis of glioblastoma (GBM, pleomorphic glioblastoma, WHO level IV)

You may not qualify if:

  • Other types of glioma by histological diagnosis
  • Tumor tissue not eligible for the central laboratory testing standard
  • No enough tumor tissue for the central laboratory test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jinsong Wu, MD

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 15, 2017

Study Start

November 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 31, 2017

Last Updated

September 21, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share