Rare Disease With Poor OutcomeNCT05347511
Study of the Pronostic Impact of Immunohistochemical, Histological and Radiological Factors in Patients With Primary Central Nervous System Lymphoma.
An observational study of Rare Disease With Poor Outcome, run by Central Hospital, Nancy, France.
Trial summary
Primary Central Nervous System Lymphoma (PCNSL) have a specific mutational profile in comparison to systemic diffuse large cells lymphoma (DLBCLs) that can be related to the expression of immunohistochemical markers as cyclon, NPM1, CD30, and P53 which could be predictive factor for prognosis and/or chemotherapy… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Rare Disease With Poor Outcome
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2022to 1 Sep 2022
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults' immunocompetent patients treated at the University Hospital of Nancy are included if they had a DLBCL's PCNSL diagnosed between January 2011 and December 2019, without regard to the clinical outcome.. All the patients are included in the LOC network database (Lymphomes oculo-cerebraux) and had given their written consent for the use of their samples for studies. Biological and clinical data will be collected for each patient from original medical charts.
Who may be able to join
- PCNSL diagnosed between January 2011 and December 2019, without regard to the clinical outcome.
- Age > 18
Who cannot join
- Systemic DLBCL
About this study
Official title: Study of the Pronostic Impact of Immunohistochemical, Histological, Radiological and Molecular Factors in Patients With Primary Central Nervous System Lymphoma
Primary Central Nervous System Lymphoma (PCNSL) have a specific mutational profile in comparison to systemic diffuse large cells lymphoma (DLBCLs) that can be related to the expression of immunohistochemical markers as cyclon, NPM1, CD30, and P53 which could be predictive factor for prognosis and/or chemotherapy response. The main objective of this study is to identify new prognostic factors and new potential therapeutic targets.
The secondary objectives are to correlate the histological, the radiological and the clinical's informations of these patients.
- Conditions
- Rare Disease With Poor Outcome
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between the survival and the expression of Cyclon, NPM1 and CD30.
kaplan meyer
Measured: 17/10/2022
Secondary outcomes (1)
the correlation between the molecular abnormalities and the expression of Cyclon, NPM1 and CD30
mutational signature
Measured: 17/10/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start20 Apr 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rare Disease With Poor OutcomeStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume GAUCHOTTE, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347511
- Sponsor's protocol ID
- 2022PI003
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2022
- Last updated
- 26 Apr 2022
- 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 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Pronostic Impact of Immunohistochemical, Histological, Radiological and Molecular Factors in Patients With Primary Central Nervous System Lymphoma
- ClinicalTrials.gov ID
- NCT05347511
- Acronym / sponsor ID
- 2022PI003
- Conditions
- Rare Disease With Poor Outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 20 Apr 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 26 Apr 2022 (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 Lymphoma (PCNSL) have a specific mutational profile in comparison to systemic diffuse large cells lymphoma (DLBCLs) that can be related to the expression of immunohistochemical markers as cyclon, NPM1, CD30, and P53 which could be predictive factor for prognosis and/or chemotherapy response. The main objective of this study is to identify new prognostic factors and new potential therapeutic targets.
The secondary objectives are to correlate the histological, the radiological and the clinical's informations of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults' immunocompetent patients treated at the University Hospital of Nancy are included if they had a DLBCL's PCNSL diagnosed between January 2011 and December 2019, without regard to the clinical outcome.. All the patients are included in the LOC network database (Lymphomes oculo-cerebraux) and had given their written consent for the use of their samples for studies. Biological and clinical data will be collected for each patient from original medical charts.
Key inclusion criteria (2 listed)
- PCNSL diagnosed between January 2011 and December 2019, without regard to the clinical outcome.
- Age > 18
Key exclusion criteria (1 listed)
- Systemic DLBCL
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
correlation between the survival and the expression of Cyclon, NPM1 and CD30.
Time frame: 17/10/2022
kaplan meyer
1 secondary outcome
the correlation between the molecular abnormalities and the expression of Cyclon, NPM1 and CD30
Time frame: 17/10/2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rare Disease With Poor Outcome, run by Central Hospital, Nancy, 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 2 inclusion and 1 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 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
correlation between the survival and the expression of Cyclon, NPM1 and CD30. (time frame: 17/10/2022). 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 26 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.