Brain CancerPROTONBIOMARKSNCT04367779
Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
An observational study of Brain Cancer and Meningioma, run by Centre Leon Berard at 2 sites in France.
Trial summary
This trial is a paucicentric, clinico-biological cohort study with retrospective and prospective enrollment, aiming to identify biomarkers predictive of response to Proton Beam Therapy (PBT) in cancer patients (high grade sarcoma, brain tumors and meningioma). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Cancer, Meningioma, Sarcoma
- How many people
- 84 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Sep 2020to 5 Sep 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Alive or Dead cancer patients with high grade sarcoma, brain tumors or meningioma Previously treated with PBT since 2016 (Retrospective cohort) or Patients to be treated with PBT (Prospective cohort)
Who may be able to join
- I1 Male or female patients, all ages are eligible.
- I2 Confirmed diagnosis of macroscopic tumor previously treated since 2016 (retrospective cohort) or to be treated (prospective cohort) with PBT including one of the following tumor types:Cohort A : high grade sarcoma ; Cohort B: brain tumors; Cohort C: meningioma.
- I3 Presence of at least one measurable lesion before PBT initiation. Post operative situation is possible providing a measurable macroscopic residue, non candidate to a new surgery before PBT.
- I4 Availability of archival representative formalin-fixed, paraffin-embedded (FFPE) and/or frozen tumor sample, with the corresponding hematoxylin and eosin stained slide and a pathological report, meeting the following quality/quantity control (QC) criteria confirmed by a central pathological review: (this sample will be also used to confirm pathological diagnosis ) : at least 20% of tumor cells and a surface area > 5mm2 with > 90μm of depth.
- I5. Performance status before PBT: Lansky Play score for pediatric patients < 12 years of age ≥ 70%; Karnofsky performance status for pediatric patients ≥ 12 years of age ≥ 70%; PS ECOG for adult patients: 0, 1 or 2.
- I6. For prospective cohort : Life-expectancy before PBT > 2 years .
- I7. For prospective cohort : Women of child-bearing potential and men must agree to use (must have used for retrospective cohort) adequate contraception during all the radiotherapy procedure
- I8. For alive patients - Written informed consent from patient, parents if applicable/legal representative, before any study-specific screening procedures, and willingness to comply to study visits and procedures.
Who cannot join
- E1. Patients previously treated with radiotherapy in the same site (re-irradiation), either with protons or photons
- E2. Pregnant or breast-feeding patients at time of PBT initiation.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Léon Bérard
Lyon, 69008
Centre Antoine Lacassagne
Nice, 06189
About this study
Official title: PROTONBIOMARKS - Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients: A Genomic, Epigenetic, and Immunological Analysis
This trial is a paucicentric, clinico-biological cohort study with retrospective and prospective enrollment, aiming to identify biomarkers predictive of response to Proton Beam Therapy (PBT) in cancer patients (high grade sarcoma, brain tumors and meningioma). This study include collection of clinical data, of tumor samples (collected during standard of care) and a blood sample for alive patients.
Read the detailed description
The proton beam model policy adopted by the American Society of Radiation Oncology (ASTRO) in 2017 supports proton therapy in primary solid neoplasms in children treated with curative intent. To date, PBT is also recognised in adults as a valid option providing life expectancy > 10 years, for inoperable axial or head and neck sarcomas, low grade brain tumors (i.e. low grade astrocytoma, oligodendroglioma and ependymoma), non-operated meningioma of skull base and other rare clinical situations (re-irradiation, locally aggressive tumor malignant or not arising in sites which preclude R0 or R1 surgical resection). Recently, Jhaveri et al. have reported the retrospective analysis of a National Cancer Data Base (NCDB) and shown an improved overall survival in adult Grade I-IV glioma patients treated with PBT versus patients treated with radiotherapy (XRT). Positive impact on toxicity free survival and general health status of patients were reported in others indications. centers join their expertise (pediatric, brain and sarcoma cancers for Centre Léon Bérard (CLB) and protons for CAL) and their recruitment to optimize the treatment strategy for these patients.
The Centre Leon Bérard recently reported on the ProfilER protocol (NCT01774409). It is the largest molecular characterization program in France with now over 4000 patients included. It enabled to identify genomic biomarkers of radio resistance. In this context, the investigator's proposal is to conduct a genomic, epigenetic, and immunological analysis of patients treated with proton beam therapy with the aim to identify Biomarkers of response to PBT in pediatric and adult patients.
- Conditions
- Brain Cancer, Meningioma, Sarcoma
- Keywords
- Proton Beam Therapy, Biomarkers, Pediatric and adult cancers, Proton Therapy
- Medical subject headings
- Brain Neoplasms, Meningioma, Sarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A : High Grade Sarcoma | Pediatric and adult patients with High Grade Sarcoma treated or to be treated with Proton Beam Therapy (PBT) and not candidate to surgery before PBT. | |
| B : Brain tumors | Pediatric and adult patients with Brain Tumors treated or to be treated with Proton Beam Therapy (PBT) and not candidate to surgery before PBT. | |
| C : Meningioma | Pediatric and adult patients with Meningioma treated or to be treated with Proton Beam Therapy (PBT) and not candidate to surgery before PBT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify predictive biomarkers for local response at 6 months after the end of Proton Beam Therapy
Correlation between local tumor response according to RECIST 1.1 criteria and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC)
Measured: At 6 months after the end of Proton Beam Therapy
Secondary outcomes (4)
To identify predictive biomarkers for clinical outcomes
Correlation between local tumor response according to RECIST 1.1 criteria and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC)
Measured: At 12 months and at 24 months after the end of Proton Beam Therapy
To identify predictive biomarkers for clinical outcomes
Correlation between progression free survival and expression of biomarkers expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC)
Measured: From the start of Proton Beam Therapy until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
To identify predictive biomarkers for clinical outcomes
Correlation between overall survival and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC)
Measured: From the start of Proton Beam Therapy until the date of death from any cause, assessed up to 48 months
To identify predictive biomarkers for clinical outcomes
Correlation between radiation related toxicity (only Adverse Event (AE) Grade ≥3) according to NCI-CTCAE V5.0. and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC)
Measured: From the start of Proton Beam Therapy until at least 24 months after the end of Proton Beam Therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start24 Sep 2020
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Other
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude Line, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367779
- Sponsor's protocol ID
- ET19-284
- Acronym
- PROTONBIOMARKS
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2020
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTONBIOMARKS - Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients: A Genomic, Epigenetic, and Immunological Analysis
- ClinicalTrials.gov ID
- NCT04367779
- Acronym / sponsor ID
- PROTONBIOMARKS / ET19-284
- Conditions
- Brain Cancer, Meningioma, Sarcoma
- Keywords
- Proton Beam Therapy, Biomarkers, Pediatric and adult cancers, Proton Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 29 Apr 2020 (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.
This trial is a paucicentric, clinico-biological cohort study with retrospective and prospective enrollment, aiming to identify biomarkers predictive of response to Proton Beam Therapy (PBT) in cancer patients (high grade sarcoma, brain tumors and meningioma). This study include collection of clinical data, of tumor samples (collected during standard of care) and a blood sample for alive patients.
Detailed description
The proton beam model policy adopted by the American Society of Radiation Oncology (ASTRO) in 2017 supports proton therapy in primary solid neoplasms in children treated with curative intent. To date, PBT is also recognised in adults as a valid option providing life expectancy > 10 years, for inoperable axial or head and neck sarcomas, low grade brain tumors (i.e. low grade astrocytoma, oligodendroglioma and ependymoma), non-operated meningioma of skull base and other rare clinical situations (re-irradiation, locally aggressive tumor malignant or not arising in sites which preclude R0 or R1 surgical resection). Recently, Jhaveri et al. have reported the retrospective analysis of a National Cancer Data Base (NCDB) and shown an improved overall survival in adult Grade I-IV glioma patients treated with PBT versus patients treated with radiotherapy (XRT). Positive impact on toxicity free survival and general health status of patients were reported in others indications. centers join their expertise (pediatric, brain and sarcoma cancers for Centre Léon Bérard (CLB) and protons for CAL) and their recruitment to optimize the treatment strategy for these patients.
The Centre Leon Bérard recently reported on the ProfilER protocol (NCT01774409). It is the largest molecular characterization program in France with now over 4000 patients included. It enabled to identify genomic biomarkers of radio resistance. In this context, the investigator's proposal is to conduct a genomic, epigenetic, and immunological analysis of patients treated with proton beam therapy with the aim to identify Biomarkers of response to PBT in pediatric and adult patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A : High Grade Sarcoma | – | –Pediatric and adult patients with High Grade Sarcoma treated or to be treated with Proton Beam Therapy (PBT) and not candidate to surgery before PBT. |
| B : Brain tumors | – | –Pediatric and adult patients with Brain Tumors treated or to be treated with Proton Beam Therapy (PBT) and not candidate to surgery before PBT. |
| C : Meningioma | – | –Pediatric and adult patients with Meningioma treated or to be treated with Proton Beam Therapy (PBT) and not candidate to surgery before PBT. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Alive or Dead cancer patients with high grade sarcoma, brain tumors or meningioma Previously treated with PBT since 2016 (Retrospective cohort) or Patients to be treated with PBT (Prospective cohort)
Key inclusion criteria (8 listed)
- I1 Male or female patients, all ages are eligible.
- I2 Confirmed diagnosis of macroscopic tumor previously treated since 2016 (retrospective cohort) or to be treated (prospective cohort) with PBT including one of the following tumor types:Cohort A : high grade sarcoma ; Cohort B: brain tumors; Cohort C: meningioma.
- I3 Presence of at least one measurable lesion before PBT initiation. Post operative situation is possible providing a measurable macroscopic residue, non candidate to a new surgery before PBT.
- I4 Availability of archival representative formalin-fixed, paraffin-embedded (FFPE) and/or frozen tumor sample, with the corresponding hematoxylin and eosin stained slide and a pathological report, meeting the following quality/quantity control (QC) criteria confirmed by a central pathological review: (this sample will be also used to confirm pathological diagnosis ) : at least 20% of tumor cells and a surface area > 5mm2 with > 90μm of depth.
- I5. Performance status before PBT: Lansky Play score for pediatric patients < 12 years of age ≥ 70%; Karnofsky performance status for pediatric patients ≥ 12 years of age ≥ 70%; PS ECOG for adult patients: 0, 1 or 2.
Key exclusion criteria (2 listed)
- E1. Patients previously treated with radiotherapy in the same site (re-irradiation), either with protons or photons
- E2. Pregnant or breast-feeding patients at time of PBT initiation.
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
Identify predictive biomarkers for local response at 6 months after the end of Proton Beam Therapy
Time frame: At 6 months after the end of Proton Beam Therapy
Correlation between local tumor response according to RECIST 1.1 criteria and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC)
4 secondary outcomes
To identify predictive biomarkers for clinical outcomes
Time frame: At 12 months and at 24 months after the end of Proton Beam Therapy
To identify predictive biomarkers for clinical outcomes
Time frame: From the start of Proton Beam Therapy until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
To identify predictive biomarkers for clinical outcomes
Time frame: From the start of Proton Beam Therapy until the date of death from any cause, assessed up to 48 months
To identify predictive biomarkers for clinical outcomes
Time frame: From the start of Proton Beam Therapy until at least 24 months after the end of Proton Beam Therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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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.
Claude Line principal investigator
Centre Leon Berard
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Cancer and Meningioma, run by Centre Leon Berard at 2 sites in France.
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 8 inclusion and 2 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: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify predictive biomarkers for local response at 6 months after the end of Proton Beam Therapy (time frame: At 6 months after the end of Proton Beam Therapy). 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 22 Apr 2026.