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CAN008 Biomarker CD95 Ligand and CpG2 Methylation in Chinese Patients With Glioblastoma

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ClinicalTrials.gov Identifier: NCT03152708
Recruitment Status : Unknown
Verified September 2017 by CANbridge Life Sciences Ltd..
Recruitment status was:  Not yet recruiting
First Posted : May 15, 2017
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
CANbridge Life Sciences Ltd.

Tracking Information
First Submitted Date May 11, 2017
First Posted Date May 15, 2017
Last Update Posted Date September 21, 2017
Estimated Study Start Date November 1, 2017
Estimated Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2017)
CD95 Ligand Positive Rate [ Time Frame: 0 day ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 11, 2017)
CpG2 Positive Rate [ Time Frame: 0 day ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CAN008 Biomarker CD95 Ligand and CpG2 Methylation in Chinese Patients With Glioblastoma
Official Title The Exploratory Study on CAN008 Biomarker CD95 Ligand and Its Promoter (CpG2) Methylation in Chinese Patients With Glioblastoma
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Chinese GBM patients
Condition Glioblastoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 11, 2017)
62
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2017
Estimated Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03152708
Other Study ID Numbers CAN-B1-008-L-009
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party CANbridge Life Sciences Ltd.
Study Sponsor CANbridge Life Sciences Ltd.
Collaborators Not Provided
Investigators
Principal Investigator: Jinsong Wu, MD Huashan Hospital
PRS Account CANbridge Life Sciences Ltd.
Verification Date September 2017