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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04822688
Enrollment
141
Registered
2021-03-30
Start date
2021-02-03
Completion date
2025-06-30
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma, Malignant Solid Neoplasm

Brief 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.

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.

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of tissue and blood samples

Sponsors

Thomas Jefferson University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cell yieldAt study completion, up to 12 monthsThis 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.
Percentage cell viabilityAt study completion, up to 12 monthsPercentage 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026