Analysis of Circulating DNA in Blood Samples of Glioma-affected Patients

NCT05964153 | Unknown DMC

• 1 other identifier: I3PT_SG2022_01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The present pilot study aims to investigate a new strategy in the liquid biopsy protocol for the diagnosis of gliomas based on the detection of circulating tumor DNA in the blood of patients with brain lesions compatible with this type of tumor. In order to increase the sensitivity of the technique, the investigators will work with raw blood samples through minimally invasive procedures. The subsequent analysis will be done with digital PCR, due to its low detection limit. The mutational results of each patient's samples will be compared with those obtained from the corresponding tissue biopsies. This step will allow the team to determine the robustness and reliability of the liquid biopsy. The grading of the tumor, as well as the confirmation of the diagnosis, will be obtained from the histological data. With the inclusion of more patients in the future, and with the optimization of the mutations investigated, the investigators want to standardize the protocol for the diagnosis of gliomas with liquid biopsy. This technique is less invasive than current surgical procedures used for diagnosis. In addition, using fewer hospital resources should allow a more accurate and rapid diagnosis of the pathology, and therefore, start the more personalized therapeutic stage earlier.

Conditions

Glioma; Circulating Tumor Cell

Keywords

Liquid Biopsy; Glioma; Circulating free DNA; ddPCR

Outcome Measures

Primary Outcomes (1)

• Circulating free DNA detection

  Circulating free DNA detection in blood samples of patients by means of a ddPCR

  1 year (2023-2024)

Study Arms (1)

Circulating free DNA analysis

EXPERIMENTAL

* Correlate the results of the tissue samples with those of the blood samples, the concentration of ctDNA found, and the magnetic resonance images prior to the biopsies. * Compare other variables such as time, money, and the impact on the patient (recovery time after biopsies, pain, sequelae,...) between the liquid biopsy procedure and the conventional tissue biopsy procedure.

Diagnostic Test: Liquid Biopsy

Interventions

Liquid Biopsy DIAGNOSTIC_TEST

Analysis of the circulating free DNA in blood patients affected by gliomas

Circulating free DNA analysis

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• De novo primary brain lesion, compatible with a glioma according to contrast-enhanced magnetic resonance images. The injury must be treated by the usual surgical procedure.
• Signature of informed consent.

You may not qualify if:

• Pregnant or breastfeeding women.
• Reasonable doubts in the diagnosis of glioma by magnetic resonance, or patients whose tissue biopsy diagnoses a brain lesion other than a glioma.
• Patients who cannot undergo surgical resection, or when the tissue samples taken are not significant enough to be analyzed.
• Inability or disagreement with signing the informed consent.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Hospital Universitari Parc Taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

MeSH Terms

Conditions

Glioma; Neoplastic Cells, Circulating

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Officials

• Silvia Gil

  Hospital Universitari Parc Taulí

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Coloma Moreno

CONTACT

+34937231010; cmoreno@tauli.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: July 27, 2023
• Study Start: January 31, 2023
• Primary Completion: July 31, 2023
• Study Completion: January 31, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)