Glioma Brain Tumours - E12513 - SensiScreen Glioma

Sensitive Diagnosis, Prognosis and Treatment Planning on Open Platform of Glioma Brain Tumours - E12513 - SensiScreen Glioma

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.

Study Overview

• Status: Recruiting
• Conditions: Glioma
• Intervention / Treatment: Genetic: validation of new technologies

• Study Type: Observational
• Enrollment (Anticipated): 220

Contacts and Locations

• Study Contact: Name: Milo Frattini, PhD; Phone Number: + 41 (0)91 816 08 05; Email: milo.frattini@eoc.ch

Study Locations

• Switzerland
  • Locarno, Switzerland, 6600
    • Recruiting
    • Institute of Pathology Ente Ospedaliero Cantonale
    • Contact: Milo Frattini, PhD; Phone Number: + 41 (0)91 816 08 05; Email: milo.frattini@eoc.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients affected by suspected glioma

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstration that the new methodology improves the features	Demostrate that are found at least the same number of mutations in comparison with respect to standard tests	2 hours

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Cantonale, Bellinzona
• Collaborators: Neurocenter of Southern Switzerland; Istituto Cantonale di Patologia
• Investigators: Study Chair: Milo Frattini, PhD, Institute of Pathology

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: ICP_glioma_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No