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Glioma Brain Tumours - E12513 - SensiScreen Glioma

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ClinicalTrials.gov Identifier: NCT04539431
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : January 24, 2022
Sponsor:
Collaborators:
Istituto Cantonale di Patologia
Neurocenter of Southern Switzerland
Information provided by (Responsible Party):
Milo Frattini, Ente Ospedaliero Cantonale, Bellinzona

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Validation of a new platform for the molecular characterization of patients affected by glioma. The new platform includes a series of faster, less expensive real-time PCR methodologies that, in comparison to standard analyses (DS, MS-PCR), are also characterized by higher sensitivity and consequently can be able to identify mutations in ctDNA extracted from liquid biopsies as well. The development of these assays will allow the analysis of molecular markers alteration even in liquid biopsies, providing a less invasive sampling than tissue biopsies, a procedure that sometimes is characterized by side effects or that allow the collection of few tissues for the histological and molecular diagnosis.

This study will not interfere with the patients routine treatment pathway and there will be no deviation from the standard of care: the molecular characterization of the tissues will be performed according to the standard diagnostic routine using the currently approved methodologies. For the retrospective study, it will be used the left-over DNA. For the cohort, that includes the collection and the subsequent analysis of liquid biopsies (prospective study), blood and CSF will be sampled during surgery.

The mutations in the molecular markers will be analyzed in tissue as well as in plasma and CFS samples by the new real-time based assays. Then, the qualitative and quantitative values obtained on liquid biopsies with the new methodology will be compared to the results of the standard methodologies already obtained, for diagnostic routine, on surgical tissue samples of the same patients.


Condition or disease Intervention/treatment
Glioma Genetic: validation of new technologies

Study Design
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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sensitive Diagnosis, Prognosis and Treatment Planning on Open Platform of Glioma Brain Tumours - E12513 - SensiScreen Glioma
Actual Study Start Date : January 7, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Retrospective
The cases with glioma will be identified in the databases of hospital, the material will be preliminarily evaluated in order to see if there is sufficient tissue left for analysis.
 Genetic: validation of new technologies
Development of a new molecular assay on tissue as well as on liquid biopsies (plasma and CSF), based on a single, open, real-time PCR platform with unprecedented sensitivity
Prospective
A blood sample for molecular analyses will be collected in all the cases, CSF samples will be taken only if recommended by the normal surgical routine.
 Genetic: validation of new technologies
Development of a new molecular assay on tissue as well as on liquid biopsies (plasma and CSF), based on a single, open, real-time PCR platform with unprecedented sensitivity


Outcome Measures
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Primary Outcome Measures :
  1. Demonstration that the new methodology improves the features [ Time Frame: 2 hours ]
    Demostrate that are found at least the same number of mutations in comparison with respect to standard tests


Biospecimen Retention:   Samples With DNA
Liquid biopsies, tissue block, blood sample

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients affected by suspected glioma
Criteria

Retrospective Cohort

Inclusion Criteria:

  • Patient with available tissue material or with available molecular data concerning the tissue biopsy obtained during surgery and analyzed for diagnosis

Exclusion Criteria:

  • Insufficient amount of tumor cells in the tissue biopsy for the molecular characterization
  • Inability to consent and follow the procedures of the study (for alive patients)

Prospective Cohort

Inclusion Criteria:

  • Age ≥ 18 years old
  • Affected by suspected glioma and requiring surgery
  • Patient with available tissue material or with available molecular data concerning the tissue biopsy obtained during surgery and analyzed for diagnosis
  • Written informed consent

Exclusion Criteria:

  • Insufficient amount of tumor cells in the tissue biopsy for the molecular characterization
  • Inability to consent and follow the procedures of the study
  • Women who are pregnant or breast feeding
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04539431


Contacts
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Contact: Milo Frattini, PhD + 41 (0)91 816 08 05 milo.frattini@eoc.ch

Locations
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Switzerland
Institute of Pathology Ente Ospedaliero Cantonale Recruiting
Locarno, Switzerland, 6600
Contact: Milo Frattini, PhD    + 41 (0)91 816 08 05    milo.frattini@eoc.ch   
Sponsors and Collaborators
Ente Ospedaliero Cantonale, Bellinzona
Istituto Cantonale di Patologia
Neurocenter of Southern Switzerland
Investigators
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Study Chair: Milo Frattini, PhD Institute of Pathology
More Information
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Responsible Party: Milo Frattini, Head, Molecular Pathology Service, Ente Ospedaliero Cantonale, Bellinzona
ClinicalTrials.gov Identifier: NCT04539431    
Other Study ID Numbers: ICP_glioma_001
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: January 24, 2022
Last Verified: January 2022
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
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue