GliomaNCT05964153
Analysis of Circulating DNA in Blood Samples of Glioma-affected Patients
A study testing Liquid Biopsy in people with Glioma and Circulating Tumor Cell, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Circulating Tumor Cell
- What is being tested?
- Liquid Biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 31 Jan 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Parc Taulí
Sabadell, Barcelona, 08208
Silvia Gil, PhD, +34937231010, sgil@tauli.cat
About this study
Official title: Pilot Study of Liquid Biopsy as a Diagnostic Tool for Gliomas by Analyzing Circulating Tumor DNA in Blood Samples, and Its Validation With the Corresponding Tissue Biopsies.
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.
Read the detailed description
Currently, brain tumors are detected by means of an imaging technique (usually magnetic resonance imaging) with a contrast agent. The determination of the type of tumor, as well as its grading, is usually done subsequently with a biopsy of the tissue, where different solid samples are extracted as representative as possible to analyze them in the Pathological Anatomy service. Nevertheless, there are some factors that limit surgical access, such as: the advanced age of the patient, the location of the tumor in eloquent or risky areas, as well as the presence of large tumors with very diffuse borders. In these cases, the diagnosis of the brain tumor is usually made directly with the magnetic resonance image, which implies a risk of error due to the lack of clinical information from this test.
Limitations like these make the minimally invasive procedure of liquid biopsy an extremely necessary diagnostic tool. For this reason, the investigators want to start a pilot study of this technique in those patients with brain lesions in the resonance images compatible with a glioma-like tumor.
In particular, the main aim of the study is to analyze the blood samples obtained from these patients in order to detect and quantify the circulating DNA (ctDNA) of tumor cells on it. These DNA fragments are expelled into the bloodstream by mechanisms still unknown as a result of numerous processes of apoptosis and necrosis of tumor cells. By analyzing them through a ddPCR, the investigators will try to detect the specific mutations present in this tumoral ctDNA, allowing the team to confirm the presence of a glioma-type tumor, and providing real-time information of its classification as astrocytoma or oligodendroglioma.
- Conditions
- Glioma, Circulating Tumor Cell
- Being tested
- Liquid Biopsy
- Keywords
- Liquid Biopsy, Glioma, Circulating free DNA, ddPCR
- Medical subject headings
- Glioma, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid BiopsyDiagnostic test
Analysis of the circulating free DNA in blood patients affected by gliomas
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Liquid Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating free DNA detection
Circulating free DNA detection in blood samples of patients by means of a ddPCR
Measured: 1 year (2023-2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start31 Jan 2023
- Primary completion31 Jul 2023
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Gil-Duran, Corporacion Parc Tauli
- Investigators
- Silvia Gil, Principal investigator, Hospital Universitari Parc Taulí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964153
- Sponsor's protocol ID
- I3PT_SG2022_01
- Status last verified
- Aug 2023
- First submitted
- 4 Apr 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Liquid Biopsy as a Diagnostic Tool for Gliomas by Analyzing Circulating Tumor DNA in Blood Samples, and Its Validation With the Corresponding Tissue Biopsies.
- ClinicalTrials.gov ID
- NCT05964153
- Acronym / sponsor ID
- I3PT_SG2022_01
- Conditions
- Glioma, Circulating Tumor Cell
- Keywords
- Liquid Biopsy, Glioma, Circulating free DNA, ddPCR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Currently, brain tumors are detected by means of an imaging technique (usually magnetic resonance imaging) with a contrast agent. The determination of the type of tumor, as well as its grading, is usually done subsequently with a biopsy of the tissue, where different solid samples are extracted as representative as possible to analyze them in the Pathological Anatomy service. Nevertheless, there are some factors that limit surgical access, such as: the advanced age of the patient, the location of the tumor in eloquent or risky areas, as well as the presence of large tumors with very diffuse borders. In these cases, the diagnosis of the brain tumor is usually made directly with the magnetic resonance image, which implies a risk of error due to the lack of clinical information from this test.
Limitations like these make the minimally invasive procedure of liquid biopsy an extremely necessary diagnostic tool. For this reason, the investigators want to start a pilot study of this technique in those patients with brain lesions in the resonance images compatible with a glioma-like tumor.
In particular, the main aim of the study is to analyze the blood samples obtained from these patients in order to detect and quantify the circulating DNA (ctDNA) of tumor cells on it. These DNA fragments are expelled into the bloodstream by mechanisms still unknown as a result of numerous processes of apoptosis and necrosis of tumor cells. By analyzing them through a ddPCR, the investigators will try to detect the specific mutations present in this tumoral ctDNA, allowing the team to confirm the presence of a glioma-type tumor, and providing real-time information of its classification as astrocytoma or oligodendroglioma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Circulating free DNA analysis | Experimental | Diagnostic Test: Liquid Biopsy* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid BiopsyAnalysis of the circulating free DNA in blood patients affected by gliomas | Diagnostic test | Circulating free DNA analysis |
Primary outcome
Circulating free DNA detection
Time frame: 1 year (2023-2024)
Circulating free DNA detection in blood samples of patients by means of a ddPCR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Gil principal investigator
Hospital Universitari Parc Taulí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid Biopsy in people with Glioma and Circulating Tumor Cell, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Coloma Moreno (+34937231010, cmoreno@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating free DNA detection (time frame: 1 year (2023-2024)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.