Clinical trial NCT04539431: Glioma Brain Tumours - E12513 - SensiScreen Glioma
Official title: Sensitive Diagnosis, Prognosis and Treatment Planning on Open Platform of Glioma Brain Tumours - E12513 - SensiScreen Glioma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
Collaborators: name: Istituto Cantonale di Patologia
name: Neurocenter of Southern Switzerland
First posted: 2020-09-07
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by suspected glioma

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.


Eligibility 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

Primary outcomes:
measure: Demonstration that the new methodology improves the features
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Locarno
country: Switzerland
facility: Institute of Pathology Ente Ospedaliero Cantonale
Study officials:
affiliation: Institute of Pathology
name: Milo Frattini, PhD
role: STUDY_CHAIR
References: