Analysis of Cell Count, Viability, and Immunogenicity of Discarded Newly Diagnosed Glioblastoma Tissue or Solid Tumor Tissues

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04822688
• Other study ID #: 21C.030
• Status: Recruiting
• Start date: February 3, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Thomas Jefferson University
• Contact: Kevin Judy, MD
• Phone: 215-955-7000
• Email: Kevin.Judy[@]jefferson.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study examines tumor tissues and blood samples to aid in the development of therapies for brain cancer and other solid tumors. Studying samples of blood and tissue from patients with glioblastoma or other solid tumor in the laboratory may help doctors understand brain tumors and better inform future treatments.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Malignant Solid Neoplasm

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of tissue and blood samples

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cell yield	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
Primary	Percentage cell viability	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