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Glioma Brain Tumours - E12513 - SensiScreen Glioma

NCT04539431 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2022-01-24

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Istituto Cantonale di Patologia

    collaborator OTHER

  • Neurocenter of Southern Switzerland

    collaborator OTHER

  • Ente Ospedaliero Cantonale, Bellinzona

    lead OTHER

Principal Investigators

  • Milo Frattini, PhD · Institute of Pathology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04539431 on ClinicalTrials.gov