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Utility of Primary Glioblastoma Cell Lines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04180046
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : April 12, 2021
Information provided by (Responsible Party):
Antonella Arcella, Neuromed IRCCS

Brief Summary:
In this study, the characterization of human malignant glioma cell lines is described. After mechanical and enzymatic digestion of glioblastoma human biopsies from Neuromed IRCCS Neurosurgery patients, the investigators analyzed the established cell lines by immunohistochemistry. The investigators have already characterized 10 cell lines and results revealed that not all cell lines are positive for glial fibrillary acidic protein (GFAP), but only one was positive: the so-called COGI cell line. Moreover, the expression of Isocitrate Dehydrogenase 1(IDH1) and alpha thalassemia/mental retardation syndrome X-linked protein (ATRX) was investigated in all established cell lines. COGI cell line was also positive for IDH1R132 mutation and for ATRX. The results of characterization were summarized in table 1.

Condition or disease
Tumor Brain Tumor

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Glioblastoma Lines as the Disease Model
Actual Study Start Date : June 26, 2019
Actual Primary Completion Date : June 26, 2019
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Establishment of primary glioblastoma cell lines [ Time Frame: 2 years ]
    Obtaining tumor biopsies to generate primary glioblastoma cell lines. Cells will also be used for phenotypic, genetic (IDH mutation and MGMT promoter methylation) and immunohistochemical characterization (e.g. glial markers GFAP, IDH1, P53, ATRX and proliferation marker Ki67), natural and synthetic drug screening in order to assess a dose-response correlation, or other molecular and cellular techniques.

Biospecimen Retention:   Samples With DNA
Representative biopsy specimens of the removed brain tumor will be sterilely removed and subjected to mechanical trituration and subsequently to enzymatic digestion with collagenase 1 and 3.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
the study population is represented by patients with glioblastoma from NeuromedIRCCS Neurosurgery, the patients have no age limits

Inclusion Criteria:

• Patients with brain tumor: Glioblastoma (grade IV WHO)

Exclusion Criteria:

  • Patients with other types of cancer
  • Patients with brain tumor recurrence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04180046

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Contact: Antonietta Arcella, PhD 3382927693

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Neuromed IRCCS Recruiting
Pozzilli, IS, Italy, 86079
Contact: Antonietta Arcella, phD    3382927693   
Sponsors and Collaborators
Neuromed IRCCS
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Principal Investigator: antonietta Arcella, PhD Neuromed IRCCS

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Antonella Arcella, Principal investigator, Neuromed IRCCS Identifier: NCT04180046    
Other Study ID Numbers: NeuroPath_01
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonella Arcella, Neuromed IRCCS:
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue