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

Sponsor
Thomas Jefferson University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04822688
Collaborator
(none)
60
1
23.9
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection

Detailed Description

PRIMARY OBJECTIVES:
  1. Assessment of cell yield and percentage of viable cells upon tissue receipt at the cell processing facility.

  2. 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:
  1. Assessment of cell yield and percentage of viable cells from other solid tumor cells shipped to the cell processing facility.
EXPLORATORY OBJECTIVE:
  1. 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Actual Study Start Date :
Feb 3, 2021
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Basic Science (Biospecimen collection)

Patients undergo collection of tissue sample during surgery. Patients also undergo collection of blood sample.

Procedure: Biospecimen Collection
Undergo collection of tissue and blood samples

Outcome Measures

Primary Outcome Measures

  1. Cell yield [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.

  2. Percentage cell viability [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Thomas Jefferson University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT04822688
Other Study ID Numbers:
  • 21C.030
First Posted:
Mar 30, 2021
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022