Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.

NCT04367779 | Completed

• 1 other identifier: ET19-284
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 2

Brief 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). This study include collection of clinical data, of tumor samples (collected during standard of care) and a blood sample for alive patients.

Conditions

Brain Cancer; Meningioma; Sarcoma

Keywords

Proton Beam Therapy; Biomarkers; Pediatric and adult cancers; Proton Therapy

Outcome Measures

Primary Outcomes (1)

• 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)

  At 6 months after the end of Proton Beam Therapy

Secondary Outcomes (4)

• To identify predictive biomarkers for clinical outcomes

  At 12 months and at 24 months after the end of Proton Beam Therapy

• To identify predictive biomarkers for clinical outcomes

  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

  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

  From the start of Proton Beam Therapy until at least 24 months after the end of Proton Beam Therapy

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (2)

Centre Léon Bérard

Lyon, 69008, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor sample(s) (FFPE and/or Frozen) from primary tumor (biopsy or surgery specimen) Blood sample (only for alive patients) collected at the time of PBT initiation or during any clinical exam performed after validation of inclusion

MeSH Terms

Conditions

Brain Neoplasms; Meningioma; Sarcoma; Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Neoplasms, Connective and Soft Tissue

Study Officials

• Claude Line

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 29, 2020
• Study Start: September 24, 2020
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

FR (2)