Brain NeoplasmsSPECTAbrainNCT02307604
SPECTAbrain: Screening Patients With Brain Tumors for Efficient Clinical Trial Access
An observational study of Brain Neoplasms, run by European Organisation for Research and Treatment of Cancer - EORTC at 2 sites in France.
Trial summary
The SPECTAbrain protocol describes a structure for screening patients with brain tumors to efficiently allocate eligible patients in relevant therapeutic biomarker-driven clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- Tumour markers testing
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- May 2016to Jan 2019
- How long will I take part?
- 5 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pathologically confirmed brain cancer at any stage.
Who may be able to join
- Pathologically confirmed newly diagnosed primary CNS tumors, with a focus on diffuse gliomas of grades II, III and IV, meningiomas from patients who are candidates for pharmacotherapy, and rare CNS tumors;
- Availability of adequate Human Biological Material (HBM): FFPE tissue sample from the primary and/or recurrent tumor and/or metastasis, obtained at the time of surgery or biopsy; minimal amount requested is detailed in the HBM guidelines. Inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional;
- At least three months life expectancy;
- Written informed consent according to ICH/GCP and national/local regulations;
- Absence of exclusion criteria, such as active hepatitis B/C or HIV, second malignancies, severe organ dysfunction, or other comorbidities that will prevent inclusion into clinical trials.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Lille
Lille, FR 59037
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere
Paris, FR 75651
About this study
Official title: Screening Platform of EORTC for Clinical Trials Access in Brain Tumors
The SPECTAbrain protocol describes a structure for screening patients with brain tumors to efficiently allocate eligible patients in relevant therapeutic biomarker-driven clinical trials. Efficiency is promoted through the creation of a clinical database of brain tumor patients and the respective human biological material biobank for molecular characterization. The main objectives are to:
- Allocate patients to clinical trials according to the clinical characteristics and molecular profile of their tumor;
- Identify or validate new molecularly defined subgroups of tumors;
- Investigate the prevalence of novel biomarkers to plan future clinical trials;
- Enable exploratory/future research;
- Facilitate establishment of quality-assured and validated tests for Central Nervous System (CNS) tumor biomarkers;
- Conditions
- Brain Neoplasms
- Being tested
- Tumour markers testing
- Keywords
- Brain tumor, Biomarkers, Screening
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumour markers testingGenetic
| Study group | Role | What they receive |
|---|---|---|
| Brain cancer | Patients with diagnosis of brain cancer at any stage Receives: Genetic: Tumour markers testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with brain malignancy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startMay 2016
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Why it stopped: This study has been merged with 1553 SPECTA, in which brain patients are enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- 0 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Michael Weller, MD, Study chair, UniversitaetsSpital Zurich - Department of Neurology, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307604
- Sponsor's protocol ID
- EORTC-1313
- Acronym
- SPECTAbrain
- Status last verified
- Jun 2019
- First submitted
- 2 Dec 2014
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Platform of EORTC for Clinical Trials Access in Brain Tumors
- ClinicalTrials.gov ID
- NCT02307604
- Acronym / sponsor ID
- SPECTAbrain / EORTC-1313
- Conditions
- Brain Neoplasms
- Keywords
- Brain tumor, Biomarkers, Screening
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This study has been merged with 1553 SPECTA, in which brain patients are enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- May 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 4 Dec 2014 (estimated)
- 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 SPECTAbrain protocol describes a structure for screening patients with brain tumors to efficiently allocate eligible patients in relevant therapeutic biomarker-driven clinical trials. Efficiency is promoted through the creation of a clinical database of brain tumor patients and the respective human biological material biobank for molecular characterization. The main objectives are to:
- Allocate patients to clinical trials according to the clinical characteristics and molecular profile of their tumor;
- Identify or validate new molecularly defined subgroups of tumors;
- Investigate the prevalence of novel biomarkers to plan future clinical trials;
- Enable exploratory/future research;
- Facilitate establishment of quality-assured and validated tests for Central Nervous System (CNS) tumor biomarkers;
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain cancer | – | Genetic: Tumour markers testingPatients with diagnosis of brain cancer at any stage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathologically confirmed brain cancer at any stage.
Key inclusion criteria (5 listed)
- Pathologically confirmed newly diagnosed primary CNS tumors, with a focus on diffuse gliomas of grades II, III and IV, meningiomas from patients who are candidates for pharmacotherapy, and rare CNS tumors;
- Availability of adequate Human Biological Material (HBM): FFPE tissue sample from the primary and/or recurrent tumor and/or metastasis, obtained at the time of surgery or biopsy; minimal amount requested is detailed in the HBM guidelines. Inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional;
- At least three months life expectancy;
- Written informed consent according to ICH/GCP and national/local regulations;
- Absence of exclusion criteria, such as active hepatitis B/C or HIV, second malignancies, severe organ dysfunction, or other comorbidities that will prevent inclusion into clinical trials.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Tumour markers testing | Genetic | Brain cancer |
Primary outcome
Number of patients with brain malignancy
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
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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.
Michael Weller, MD study chair
UniversitaetsSpital Zurich - Department of Neurology, Zurich, Switzerland
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 Neoplasms, run by European Organisation for Research and Treatment of Cancer - EORTC 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 5 inclusion and 0 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: withdrawn, as of the sponsor's last update on 24 Jun 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of patients with brain malignancy (time frame: 5 years). 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 24 Jun 2019; AzTrials last refreshed its copy on 6 Nov 2026.