High Grade GliomaSOPRANONCT05630664
Liquid Biopsy in High-grade Gliomas and Meningiomas
An observational study of High Grade Glioma and High Grade Meningioma, run by IRCCS San Raffaele at 5 sites in Italy.
Trial summary
The general objective of this project is to evaluate the value of cell-free DNA circulating in plasma as a marker of tumor evolution in patients with high-grade gliomas and meningiomas. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- High Grade Glioma, High Grade Meningioma
- How many people
- 90 participants
- Where
- 5 sitesItaly
- Study dates
- 1 Oct 2022to 30 Sep 2025
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients with a newly diagnosed brain lesion compatible with high-grade glioma or high-grade meningioma, for whom a brain biopsy or exeresis has been indicated. Patients of both sexes, aged between 18 and 85 years-old, with a Karnofsky Performance Status (KPS)≥ 60 will be enrolled.
Who may be able to join
- Age ≥ 18 years
- Finding, on an MRI scan of the brain with gadolinium, of a brain lesion compatible with a primary brain tumor, intra- or extra-axial, suspected for a high-grade glioma or a high-grade meningioma, manifested with new onset neurological symptoms
- Clinical indication to perform a biopsy or surgical resection of the lesion
- Karnofsky Performance Status (KPS) ≥ 60
- Signature of informed consent
Who cannot join
- Absolute contraindications to magnetic resonance imaging or to the administration of gadolinium (e.g. patients with pacemakers or other non-magneto-compatible devices)
- Known positivity for HIV, HCV or HBV
- There are clinical, biological or instrumental data suggesting that the brain lesion is non-neoplastic in nature (e.g., abscess, vascular malformation, inflammatory disease of the Central Nervous System)
- Women who are pregnant or breastfeeding
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites, 4 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, MI, 20132
Gaetano Finocchiaro, MD, +390226435258, finocchiaro.gaetano@hsr.it
Giulia Berzero, MD
- Not yet recruiting
Istituto Oncologico Veneto
Padova, PD, 35128
Giuseppe Lombardi, MD, giuseppe.lombardi@iov.veneto.it
- Active, not recruiting
Istituto Nazionale Tumori Regina Elena
Roma, RM, 00144
- Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, 00168
Quintino Giorgio D' Alessandris, MD, quintinogiorgio.dalessandris@policlinicogemelli.it
Luca Boldrini, MD
- Not yet recruiting
Istituto Clinico Humanitas IRCCS
Rozzano, MI, 20089
Matteo Simonelli, MD, matteo.simonelli@hunimed.eu
About this study
Official title: Prospective Observational Study for the Implementation of Liquid Biopsy in the Follow-up of Patients With High-grade Gliomas and Meningiomas
The general objective of this project is to evaluate the value of cell-free DNA circulating in plasma as a marker of tumor evolution in patients with high-grade gliomas and meningiomas.
To this end, we propose to longitudinally collect four samples of plasma at the following time points:
- T0: before surgery;
- T1: one month after surgery;
- T2: one month after the end of radiotherapy;
- T3 at the time of radiological progression.
The goal is to evaluate whether changes in plasma concentration of circulating cell-free DNA can help predict progression-free survival, overall survival, and response to therapies.
- Conditions
- High Grade Glioma, High Grade Meningioma
- Medical subject headings
- Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
cfDNA correlation with PFS
To evaluate whether circulating free DNA concentration in plasma at diagnosis correlates with progression-free survival.
Measured: 1-3 days before surgery until disease progression (or at month 12 after surgery in the absence of disease progression)
Secondary outcomes (4)
cfDNA correlation with OS
To valuate whether the concentration of circulating free DNA in plasma at the time of diagnosis correlates with overall survival
Measured: 1-3 days before surgery until patient death (or at month 12 if patient is alive)
correlation between change in cfDNA concentration after surgery and PFS and OS
To evaluate whether a reduction in plasma concentration of circulating free DNA compared to preoperative values (T0) is seen one month after the surgical procedure (T1) and if this reduction is predictive of progression-free survival and overall survival.
Measured: from day 30 (+/- 3 days) after surgery until disease progression, patient death (or at month 12 after surgery in the absence of disease progression)
correlation between change in cfDNA concentration one month after radiotherapy completion and tumor volume changes, as well as clinical status changes
To evaluate, one month after the completion of radio (chemo) therapy (T2), the plasma concentration of circulating free DNA with respect to the pre-treatment values (T1), correlating with the volumetric and radiomic variations of the tumor in the magnetic resonance images (FLAIR sequence and T1 after injection of contrast medium), as well as with the changes in the patient's neurological status measured by the NANO score (Nayak et al., 2017) at the same timepoints.
Measured: values assessed at month 3.5 after surgery (+/- one week) compared with values assessed 1-3 days before surgery
cfDNA concentration changes at progression
To evaluate at the time of suspected radiological progression (T3) the plasma concentration of circulating free DNA and its variations compared to the values detected one month after the end of radio (chemo) therapy (T2).
Measured: values at the time of suspected radiological progression (or at month 12 in the absence of suspected radiological progression) compared with values assessed at month 3.5 after surgery (+/- one week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Oct 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Alleanza Contro il Cancro
- Responsible party
- Principal investigator, Gaetano Finocchiaro, IRCCS San Raffaele
- Investigators
- Gaetano Finocchiaro, MD, Principal investigator, Ospedale San Raffaele, Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630664
- Sponsor's protocol ID
- ACCSOPRANO-22
- Acronym
- SOPRANO
- Status last verified
- Nov 2022
- First submitted
- 14 Sep 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study for the Implementation of Liquid Biopsy in the Follow-up of Patients With High-grade Gliomas and Meningiomas
- ClinicalTrials.gov ID
- NCT05630664
- Acronym / sponsor ID
- SOPRANO / ACCSOPRANO-22
- Conditions
- High Grade Glioma, High Grade Meningioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Alleanza Contro il Cancro
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 30 Nov 2022 (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 general objective of this project is to evaluate the value of cell-free DNA circulating in plasma as a marker of tumor evolution in patients with high-grade gliomas and meningiomas.
To this end, we propose to longitudinally collect four samples of plasma at the following time points:
- T0: before surgery;
- T1: one month after surgery;
- T2: one month after the end of radiotherapy;
- T3 at the time of radiological progression.
The goal is to evaluate whether changes in plasma concentration of circulating cell-free DNA can help predict progression-free survival, overall survival, and response to therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients with a newly diagnosed brain lesion compatible with high-grade glioma or high-grade meningioma, for whom a brain biopsy or exeresis has been indicated. Patients of both sexes, aged between 18 and 85 years-old, with a Karnofsky Performance Status (KPS)≥ 60 will be enrolled.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Finding, on an MRI scan of the brain with gadolinium, of a brain lesion compatible with a primary brain tumor, intra- or extra-axial, suspected for a high-grade glioma or a high-grade meningioma, manifested with new onset neurological symptoms
- Clinical indication to perform a biopsy or surgical resection of the lesion
- Karnofsky Performance Status (KPS) ≥ 60
- Signature of informed consent
Key exclusion criteria (4 listed)
- Absolute contraindications to magnetic resonance imaging or to the administration of gadolinium (e.g. patients with pacemakers or other non-magneto-compatible devices)
- Known positivity for HIV, HCV or HBV
- There are clinical, biological or instrumental data suggesting that the brain lesion is non-neoplastic in nature (e.g., abscess, vascular malformation, inflammatory disease of the Central Nervous System)
- Women who are pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cfDNA correlation with PFS
Time frame: 1-3 days before surgery until disease progression (or at month 12 after surgery in the absence of disease progression)
To evaluate whether circulating free DNA concentration in plasma at diagnosis correlates with progression-free survival.
4 secondary outcomes
cfDNA correlation with OS
Time frame: 1-3 days before surgery until patient death (or at month 12 if patient is alive)
correlation between change in cfDNA concentration after surgery and PFS and OS
Time frame: from day 30 (+/- 3 days) after surgery until disease progression, patient death (or at month 12 after surgery in the absence of disease progression)
correlation between change in cfDNA concentration one month after radiotherapy completion and tumor volume changes, as well as clinical status changes
Time frame: values assessed at month 3.5 after surgery (+/- one week) compared with values assessed 1-3 days before surgery
cfDNA concentration changes at progression
Time frame: values at the time of suspected radiological progression (or at month 12 in the absence of suspected radiological progression) compared with values assessed at month 3.5 after surgery (+/- one week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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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.
Gaetano Finocchiaro, MD principal investigator
Ospedale San Raffaele, Milano, Italy
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Grade Glioma and High Grade Meningioma, run by IRCCS San Raffaele at 5 sites in Italy.
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 5 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 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. 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 Gaetano Finocchiaro, MD (+390226435568, finocchiaro.gaetano@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cfDNA correlation with PFS (time frame: 1-3 days before surgery until disease progression (or at month 12 after surgery in the absence of disease progression)). 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 2 Dec 2022.