- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04822688
Analysis of Cell Count, Viability, and Immunogenicity of Discarded Newly Diagnosed Glioblastoma Tissue or Solid Tumor Tissues
Analysis of Cell Count, Viability, and Immunogenicity of Deidentified Discarded Newly Diagnosed Glioblastoma Tissue and More Broadly Other Newly Diagnosed Solid Tumor Tissues From the Operating Room
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Assessment of cell yield and percentage of viable cells upon tissue receipt at the cell processing facility.
II. Obtain discarded tumor tissue from surgical resections for further studies to aid in development of future therapies for glioblastoma (GBM) and other solid tumors.
SECONDARY OBJECTIVE:
I. Assessment of cell yield and percentage of viable cells from other solid tumor cells shipped to the cell processing facility.
EXPLORATORY OBJECTIVE:
I. An additional line of inquiry will be devoted to scientific exploration of the product's immunogenicity looking at important variables in the course of manufacture.
OUTLINE:
Patients undergo collection of tissue sample during surgery. Patients also undergo collection of blood sample.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Provide signed and dated informed consent form
- Any individual >= 18 years old
- Patients must have GBM or other solid tumor and undergoing surgery for diagnostic and therapeutic purposes
Exclusion Criteria:
- Individuals less than 18 years old
- Unable to understand and give consent
- Patients who are not surgical candidates
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Basic Science (Biospecimen collection)
Patients undergo collection of tissue sample during surgery.
Patients also undergo collection of blood sample.
|
Undergo collection of tissue and blood samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cell yield
Time Frame: At study completion, up to 12 months
|
This will be determined for each sample.
Cell yield data is measured in 106and is assumed to be normally distributed.
Summary statistics of mean, standard deviation, 95% confidence interval and range will be reported.
|
At study completion, up to 12 months
|
|
Percentage cell viability
Time Frame: At study completion, up to 12 months
|
Percentage cell viability will be calculated by the number of viable cells divided by the cell yield.
The mean will be computed using the sum of the viable cells divided by the sum of cell yield.
The range of percentage cell viability and 95% confidence interval will be provided.
|
At study completion, up to 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21C.030
- JT 16542 (Other Identifier: JeffTrial Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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