A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours (BrainStorm)

March 27, 2023 updated by: Jules Bordet Institute

A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program

Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental.

Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome.

In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Anderlecht, Belgium, 1070
        • Recruiting
        • Institut Jules Bordet
        • Principal Investigator:
          • Andrea Gombos
        • Contact:
          • Sylvie Bartholomeus
      • Brussels, Belgium, 1070
        • Recruiting
        • Hopital Erasme
        • Contact:
        • Principal Investigator:
          • Florence Lefranc, MD
      • Bruxelles, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires St Luc
        • Contact:
          • Nathalie Blondeel
      • Charleroi, Belgium, 6000
        • Recruiting
        • Grand Hôpital de Charleroi
        • Contact:
          • Veronique Petre
      • Gent, Belgium, 9000
        • Recruiting
        • Universitair Ziekenhuis Gent
        • Contact:
          • Lore Vansteelant
      • Jette, Belgium, 1090
        • Recruiting
        • UZ Brussel
        • Principal Investigator:
          • Lore Decoster
        • Contact:
          • Malika Tahiri
      • Leuven, Belgium, 3000
      • Mons, Belgium, 7000
        • Recruiting
        • CHU Ambroise Pare
        • Contact:
          • Anna-Maria Barbuto
        • Principal Investigator:
          • Stéphane Holbrechts
      • Namur, Belgium, 5000
        • Recruiting
        • CHU UCL Namur - Site De Sainte-Elisabeth
        • Contact:
          • Dominique Crasson
        • Principal Investigator:
          • Vincent Vanhaudenarde
  • France
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
        • Principal Investigator:
          • Claire Cheymol, MD
      • Marseille, France, 13273
        • Recruiting
        • Institut Paoli-Calmettes
        • Contact:
        • Principal Investigator:
          • Anthony Goncalves, MD
      • Paris, France, 75248
        • Recruiting
        • Institut Curie
        • Contact:
          • Imen Hafsi
        • Principal Investigator:
          • Edith Borcoman, MD
      • Paris, France, 75020
        • Recruiting
        • Institut Universitaire de Cancérologie AP-HP Sorbonne Université, Hopital Tenon
        • Contact:
      • Rouen, France, 76038
      • Strasbourg, France, 67200
        • Recruiting
        • CHU Strasbourg
        • Contact:
          • Sherine Anajar
      • Toulouse, France, 31059
        • Recruiting
        • Institut Universitaire du Cancer - Oncopole
        • Contact:
        • Principal Investigator:
          • Eleonora De Maio Desposito, MD
  • Luxembourg
      • Luxembourg, Luxembourg, 1445
        • Recruiting
        • Centre Hospitalier de Luxembourg
        • Contact:
        • Principal Investigator:
          • Caroline Duhem, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  3. Female or Male

  4. Eligible for part A: Subjects (from cohorts 1 to 5) with newly diagnosed or up to 24 months from diagnosis of non-CNS metastases. Enrolment of exceptional cases surpassing 24 months from diagnosis will be allowed for up to 20% of subjects enrolled with HER2+ BC (cohort 2) and NSCLC harbouring driver mutations (cohort 3).

    Eligible for part B: Subjects (from cohorts 1 to 7) presenting with a first CNS event and not yet enrolled in the program

    Seven cohorts of subjects are defined in this prospective multicenter study:

    • Cohort 1: Triple negative breast cancer (TNBC)
    • Cohort 2: HER 2 positive breast cancer (HER2+ BC)
    • Cohort 3: Non-small cell lung cancer (NSCLC)
    • Cohort 4: Small cell lung cancer (SCLC)
    • Cohort 5: Melanoma
    • Cohort 6: Other solid tumours (apart from the above mentioned subtypes
    • Cohort 7: Radiologically or cytologically confirmed leptomeningeal carcinomatosis
  5. Availability of either primary and/or non-CNS metastatic archival tumour tissue is mandatory for inclusion.
  6. Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical contra-indications
  7. Predicted life expectancy > 3 months.
  8. Women of childbearing potential must have a negative urine pregnancy test done within 28 days prior to enrolment
  9. Effective contraception is in place for women of childbearing potential
  10. Completion of all necessary screening procedures within 28 days prior to enrolment.

  11. Signed Informed Consent form (ICF) obtained prior to any study related procedure.

    Inclusion criterion applicable to FRANCE only

  12. Affiliated to the French Social Security System

Exclusion Criteria:

  1. Pregnant and/or lactating women.
  2. Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.

  3. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.

    Exclusion criterion applicable to FRANCE only

  4. Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CNS metastases from solid tumours

The study will be organised on three time-periods based on the time of the 1st CNS event:

Part A - Pre-diagnosis period: before diagnosis of the 1st CNS event Part B - At 1st CNS diagnosis period Part C - Post diagnosis period: after the 1st CNS event
Other: Samples collection: Plasma

At baseline

Part A:

  • TNBC/ HER2+ BC: once a year
  • NSCLC/SCLC: every 4 months
  • Melanoma: every 6 months

Part B:

o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis

Part C:

o Every 3 months (+/- 1 month)

Other Names:
  • Blood for plasma preparation
Other: Samples collection: CSF
Part B: Mandatory CSF sampling at CNS diagnosis when clinically possible unless medically contra-indicated - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis Part C: Additional CSF sampling in case CSF sampling is performed for routine clinical practice
Other Names:
  • CSF sample
Other: Samples collection: Non-CNS Metastatic Tumour Tissue
Part B: Highly recommended non-CNS metastatic tumour tissue collection (1FFPE and 1 FT) at CNS metastases diagnosis (Part B) (NB: Bone lesions are excluded) - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis
Other Names:
  • Non-CNS Metastatic Tumour Tissue collection
Other: Brain MRI

Part A:

  • Brain MRI at inclusion is allowed within 45 days before enrolment
  • Brain MRI pre-CNS diagnosis (Part A) : HER2 BC/TNBC: once a year; NSCLC/SCLC: every 4 months; Melanoma: every 6 months (+/- 1 month)

Part B:

o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis

Part C:

o Brain MRI post-CNS diagnosis (Part C): every 3 months (+/- 1 month window)

Other: Samples collection: Serum

At baseline

Part A:

  • TNBC/ HER2+ BC: once a year
  • NSCLC/SCLC: every 4 months
  • Melanoma: every 6 months

Part B:

o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis for cohorts 1-5.

Other Names:
  • Blood for serum preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Better understanding of the epidemiology of CNS metastases from solid tumours
Time Frame: through study completion, approximately 96 months

To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including:

  • Time to the first CNS event
  • Time to the second CNS after first treatment and subsequent CNS events
through study completion, approximately 96 months
Better understanding of the epidemiology of CNS metastases from solid tumours
Time Frame: through study completion, approximately 96 months

To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including::

- Time to whole brain radiotherapy
through study completion, approximately 96 months
Better understanding of the epidemiology of CNS metastases from solid tumours
Time Frame: through study completion, approximately 96 months

To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including:

- Overall survival
through study completion, approximately 96 months
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
Time Frame: through study completion, approximately 96 months

To collect data regarding the biology of CNS metastases by investigating on:

- Presence of CSF-ctDNA at diagnosis of CNS metastases
through study completion, approximately 96 months
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
Time Frame: through study completion, approximately 96 months

To collect data regarding the biology of CNS metastases by investigating on:

- Presence of plasma ctDNA at diagnosis of CNS metastases
through study completion, approximately 96 months
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
Time Frame: through study completion, approximately 96 months
  • quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS
  • deep targeted next-generation sequencing (NGS) on DNA samples from primary or non-CNS metastases as well as germline DNA samples and CNS metastases if surgery
through study completion, approximately 96 months
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
Time Frame: through study completion, approximately 96 months
- A set of 1-3 point mutations (single nucleotide variants) will be selected for each subject based on the above analyses for the identification and quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS
through study completion, approximately 96 months
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
Time Frame: through study completion, approximately 96 months
- Standard analyses cytology and biochemistry analyses
through study completion, approximately 96 months
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
Time Frame: through study completion, approximately 96 months
- Quantitative measurement of serum neuron-specific enolase
through study completion, approximately 96 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Better understand the predictive value of NSE for the development of CNS metastases on subjects with newly diagnosed non-CNS metastatic solid tumours with high risk of developing CNS metastases.
Time Frame: through study completion, approximately 96 months

To collect data regarding the biology of CNS metastases by investigating on :

  • Time to the first CNS event
  • Time to the second CNS event
  • Time to whole brain radiotherapy (WBR)
  • Time from the date of diagnosis of the first CNS event and the time of death by any cause
through study completion, approximately 96 months
Better understand the predictive value of NSE for the development of CNS metastases on subjects with newly diagnosed non-CNS metastatic solid tumours with high risk of developing CNS metastases.
Time Frame: through study completion, approximately 96 months
Levels of neuron specific enolase in blood
through study completion, approximately 96 months
Better understand the predictive value of NSE for the development of CNS metastases on subjects with newly diagnosed non-CNS metastatic solid tumours with high risk of developing CNS metastases.
Time Frame: through study completion, approximately 96 months
Deep targeted next-generation sequencing (NGS) on DNA samples from primary or non CNS metastases as well as germline DNA samples and CNS metastases if surgery. A set of 1-3 point mutations (single nucleotide variants) will be selected for each subject based on the above analyses for the identification and quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS. Subsequently targeted gene sequencing will be performed on DNA samples from CSF and plasma in case of at least 5% tumour mutant allele frequency (MAF) and CNS metastases in case of surgery.
through study completion, approximately 96 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jules Bordet Institute

Collaborators

Bristol-Myers Squibb
La Fondation contre le cancer, Belgique
Les Amis de l'Institut Bordet
Fondation Cancer, Luxembourg

Investigators

  • Study Chair: Nuria Kotecki, MD, Jules Bordet Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

January 1, 2027

Study Completion (Anticipated)

January 1, 2028

Study Registration Dates

First Submitted

July 12, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (Actual)

September 30, 2019

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IJB-BS-ODN-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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