Lymphoma, B-CellNCT05133505
Characterisation of TIM-3/Gal-9 Immune Checkpoints in Primary Central Nervous System Diffuse Large B Cell Lymphomas
An observational study of Lymphoma, B-Cell, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Primary central nervous system diffuse large B cell lymphoma is a rare and aggressive entity of diffuse large B cell lymphoma. A previous transcriptomic study showed an overexpression of TIM-3 and Gal-9 in the tumor microenvironment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-Cell
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2002to 1 Nov 2021
- 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: All patient of Primary central nervous system diffuse large B cell lymphoma
Who may be able to join
- patient with a Diagnosis of LBDGC-SNC
Who cannot join
- immunocompromised patients
- patients with a history of previous or associated low-grade lymphoma
- patients with a history of systemic LBDGC with secondary localization to the SNC
Trial locations and contacts
1 site in 1 country.
About this study
Primary central nervous system diffuse large B cell lymphoma is a rare and aggressive entity of diffuse large B cell lymphoma. A previous transcriptomic study showed an overexpression of TIM-3 and Gal-9 in the tumor microenvironment. The investigators aimed to characterise TIM-3/Gal-9 immune checkpoints by using immunohistochemistry in the tumor microenvironment of primary central nervous system diffuse large B cell lymphoma.
- Conditions
- Lymphoma, B-Cell
- Medical subject headings
- Lymphoma, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
TIM-3 and Gal-9 immunohistochemical expression
TIM-3 and Gal-9 immunohistochemical expression by tumor and microenvironment cells
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Jan 2002
- Primary completion1 Oct 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- aline desrumaux, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133505
- Sponsor's protocol ID
- RECHMPL21_0665
- Status last verified
- Nov 2021
- First submitted
- 12 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of TIM-3/Gal-9 Immune Checkpoints in Primary Central Nervous System Diffuse Large B Cell Lymphomas
- ClinicalTrials.gov ID
- NCT05133505
- Acronym / sponsor ID
- RECHMPL21_0665
- Conditions
- Lymphoma, B-Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 24 Nov 2021 (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.
Primary central nervous system diffuse large B cell lymphoma is a rare and aggressive entity of diffuse large B cell lymphoma. A previous transcriptomic study showed an overexpression of TIM-3 and Gal-9 in the tumor microenvironment. The investigators aimed to characterise TIM-3/Gal-9 immune checkpoints by using immunohistochemistry in the tumor microenvironment of primary central nervous system diffuse large B cell lymphoma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient of Primary central nervous system diffuse large B cell lymphoma
Key inclusion criteria (1 listed)
- patient with a Diagnosis of LBDGC-SNC
Key exclusion criteria (3 listed)
- immunocompromised patients
- patients with a history of previous or associated low-grade lymphoma
- patients with a history of systemic LBDGC with secondary localization to the SNC
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
TIM-3 and Gal-9 immunohistochemical expression
Time frame: 1 day
TIM-3 and Gal-9 immunohistochemical expression by tumor and microenvironment cells
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 24 Nov 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
aline desrumaux, MD, PhD principal investigator
University Hospital, Montpellier
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 Lymphoma, B-Cell, run by University Hospital, Montpellier 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 1 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: finished, as of the sponsor's last update on 24 Nov 2021. 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?
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?
TIM-3 and Gal-9 immunohistochemical expression (time frame: 1 day). 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 Nov 2021.