Glioma Brain Tumours - E12513 - SensiScreen Glioma

NCT04539431 | Unknown

• 1 other identifier: ICP_glioma_001
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

validation of new technologies GENETIC

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; Retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by suspected glioma

You may qualify if:

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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead
• Istituto Cantonale di Patologia: collaborator
• Neurocenter of Southern Switzerland: collaborator

Study Sites (1)

Institute of Pathology Ente Ospedaliero Cantonale

Locarno, 6600, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Liquid biopsies, tissue block, blood sample

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Milo Frattini, PhD

  Institute of Pathology

  STUDY CHAIR

Central Study Contacts

Milo Frattini, PhD

CONTACT

+ 41 (0)91 816 08 05; milo.frattini@eoc.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Molecular Pathology Service

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: January 7, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)