Central Nervous System LymphomaALYCEmolecularNCT03859544
Molecular Prognosis of Lymphomas of the Central Nervous System (ALYCE-molecular)
An observational study of Central Nervous System Lymphoma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Central nervous system lymphoma (PCNSL) is a diffuse large B cell lymphoma (DLBCL) entity with a particularly poor prognosis (median survival less than 3 years). They are still poorly characterized biologically, largely because of their rarity (300 cases / year in France) and the difficulty for obtaining a material of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Lymphoma
- What is being tested?
- Retrospective study
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 1 Jan 2020
- 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
- Adult, Older adult
Study population: This study focuses on adult subjects (male and female) with central nervous system lymphoma.
Who may be able to join
- Adults
- With a lymphoma of the central nervous system
- Patients having signed the consent for the conservation of their samples within the cohort
Who cannot join
- <18 old years
- Other diagnosis than lymphoma of the central nervous system
- No consent form signed
Trial locations and contacts
1 site in 1 country.
Hervé GHESQUIERES, Pr contact
Pierre SUJOBERT, Dr contact
France1 site, 1 recruiting
- Recruiting
Service d'hématologie biologique - Centre Hospitalier Lyon Sud - HCL
Pierre-Bénite, 69495
Pierre SUJOBERT, Dr, pierre.sujobert@chu-lyon.fr
About this study
Central nervous system lymphoma (PCNSL) is a diffuse large B cell lymphoma (DLBCL) entity with a particularly poor prognosis (median survival less than 3 years). They are still poorly characterized biologically, largely because of their rarity (300 cases / year in France) and the difficulty for obtaining a material of sufficient quality and quantity. It is nevertheless assumed that their pathophysiology is particular, since they develop exclusively in an immunological sanctuary, and that they present some characteristic molecular abnormalities (mutation of MYD88 or TBL1XR1 for example).
A collection of 74 PCNSLs has created, clinically annotated, from which frozen material is available in addition to the material fixed and included in paraffin (cohort ALYCE). Informed consent was gathered for all patients. Comparative Genomic Hybridization-array analysis of this cohort has already revealed abnormalities associated with a poor prognosis (unpublished data). The objective of this study is to complete this analysis by sequencing a panel of 96 mutant genes recurrently in DLBCLs and PCNSLs, and the molecular determination of the original cell by the (RT-MLPA) Reverse Transcriptase-Multiplex Ligation-dependent Probe Amplification technique.
The integration of genetic, molecular and transcriptomic data may define prognostic markers and open perspectives for translational research in PCNSL.
- Conditions
- Central Nervous System Lymphoma
- Being tested
- Retrospective study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective studyOther
Retrospective study to search mutations associated with Central nervous system lymphoma and study of the prognostic impact (overall survival and progression-free survival) of these mutations.
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Analysis of progression-free survival correlated with genomic data and mutation data
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Jan 2016
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System LymphomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859544
- Sponsor's protocol ID
- 69HCL17_0692
- Acronym
- ALYCEmolecular
- Status last verified
- Feb 2019
- First submitted
- 28 Feb 2019
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Prognosis of Lymphomas of the Central Nervous System (ALYCE-molecular)
- ClinicalTrials.gov ID
- NCT03859544
- Acronym / sponsor ID
- ALYCEmolecular / 69HCL17_0692
- Conditions
- Central Nervous System Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 1 Mar 2019 (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.
Central nervous system lymphoma (PCNSL) is a diffuse large B cell lymphoma (DLBCL) entity with a particularly poor prognosis (median survival less than 3 years). They are still poorly characterized biologically, largely because of their rarity (300 cases / year in France) and the difficulty for obtaining a material of sufficient quality and quantity. It is nevertheless assumed that their pathophysiology is particular, since they develop exclusively in an immunological sanctuary, and that they present some characteristic molecular abnormalities (mutation of MYD88 or TBL1XR1 for example).
A collection of 74 PCNSLs has created, clinically annotated, from which frozen material is available in addition to the material fixed and included in paraffin (cohort ALYCE). Informed consent was gathered for all patients. Comparative Genomic Hybridization-array analysis of this cohort has already revealed abnormalities associated with a poor prognosis (unpublished data). The objective of this study is to complete this analysis by sequencing a panel of 96 mutant genes recurrently in DLBCLs and PCNSLs, and the molecular determination of the original cell by the (RT-MLPA) Reverse Transcriptase-Multiplex Ligation-dependent Probe Amplification technique.
The integration of genetic, molecular and transcriptomic data may define prognostic markers and open perspectives for translational research in PCNSL.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study focuses on adult subjects (male and female) with central nervous system lymphoma.
Key inclusion criteria (3 listed)
- Adults
- With a lymphoma of the central nervous system
- Patients having signed the consent for the conservation of their samples within the cohort
Key exclusion criteria (3 listed)
- <18 old years
- Other diagnosis than lymphoma of the central nervous system
- No consent form signed
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 |
|---|---|---|
| Retrospective studyRetrospective study to search mutations associated with Central nervous system lymphoma and study of the prognostic impact (overall survival and progression-free survival) of these mutations. | Other | – |
Primary outcome
Progression free survival
Time frame: Up to 48 months
Analysis of progression-free survival correlated with genomic data and mutation data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Hervé GHESQUIERES, Pr contact
Pierre SUJOBERT, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Lymphoma, run by Hospices Civils de Lyon at 1 site 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 3 inclusion and 3 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 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hervé GHESQUIERES, Pr (herve.ghesquieres@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: Up to 48 months). 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 1 Mar 2019.