To Characterize and Compare Clinical, Pathological and Molecular FeaturesNCT03378947
EBV-associated Diffuse Large B Cell Lymphoma
An observational study of To Characterize and Compare Clinical, Pathological and Molecular Features, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The aim of this study is to characterize and compare clinical, pathological (histology, immunophenotype) and molecular features of EBV-related GZL and DLBCL: do they belong to the same entity or to two different subtypes of EBV-related lymphoma ? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Characterize and Compare Clinical, Pathological and Molecular Features
- What is being tested?
- clinical and pathological data EBV-related GZL and DLBCL
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2017to 1 Nov 2018
- 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: Investigators will retrospectively collect clinical and pathological data of all EBV-related GZL and DLBCL in immunocompetent patients diagnosed in the pathology department Centre Hospitalier Lyon Sud since 2000.
Who may be able to join
- all EBV-related GZL and DLBCL in immunocompetent patients
- Age minimum: 18 years old
Who cannot join
- Another diagnosis than EBV-related GZL and DLBCL
- <18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EBV-associated Diffuse Large B Cell Lymphoma NOS in Non Immunocompromised Patients : a French Retrospective Case Study
The aim of this study is to characterize and compare clinical, pathological (histology, immunophenotype) and molecular features of EBV-related GZL and DLBCL: do they belong to the same entity or to two different subtypes of EBV-related lymphoma ?
Read the detailed description
Recent progresses in the understanding of lymphoma biology allowed the identification of new categories in the WHO classification of lymphoid neoplasm. Among these new entities, grey zone lymphoma (GZL) between classical Hodgkin lymphoma and diffuse large B cell lymphoma entered the classification as a provisional entity in 2008 and Diffuse large B cell lymphoma (DLBCL) EBV-associated not otherwise specified in patient without history of immunodepression in 2016. These entities need however to be further characterized as no clear pathological definition and distinction between EBV related GZL and EBV related DLBCL are proposed in the literature.
After primary infection that occurs in almost 80% of young adult population in western country, EBV latency state settles in a small portion of B cells. The virus is known to promote B-cells proliferation and transformation through complex mechanisms.
EBV-associated lymphoproliferative disorders have already been largely studied in immunocompromised host (human immunodeficiency virus, congenital immunodeficiency, immunosuppressor and post-transplant lymphoproliferative disorder, e.g.), but its role is largely unknown in patients with no history of immunodeficiency. Whether these patients arbor an underlying type of immune deficiency has not yet been established, even though immunosenecence in elderly or immaturity of the immune system in children has been postulated in those population.
Based on former definition, EBV-associated lymphoproliferation were usually the apanage of classical Hodgkin lymphoma (cHL) or immunodeficiency-associated lymphoproliferative disorders. However, as published recently, several different histological patterns with intermediate features between primary mediastinal B cell lymphoma (PMBCL) and classical Hodgkin lymphoma (cHL), namely grey zone lymphoma (GZL), but also diffuse large B cell lymphoma (DLBCL) were described to be EBV-associated. On the clinical point of view, patients with GZL are young and have a poor prognosis. Data regarding EBV+ DLBCL are discordant and further studies are warranted, even though initial report concluded to a poor prognosis for these patients.
- Being tested
- clinical and pathological data EBV-related GZL and DLBCL
- Keywords
- EBV, DLBCL
- Medical subject headings
- Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical and pathological data EBV-related GZL and DLBCLOther
Invesrigators will retrospectively collect clinical and pathological data of all EBV-related GZL and DLBCL in immunocompetent patients diagnosed in the pathology department Centre Hospitalier Lyon Sud.
Investigators will analyze their clinical feature and prognosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
status at last follow up
Investigators will retrospectively collect clinical and pathological data of all EBV-related GZL and DLBCL in immunocompetent patients diagnosed in the pathology department Centre Hospitalier Lyon Sud.- Clinical data will be extracted from medical records, outcome and status at last follow up.
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 posted20 Dec 2017
- Study start1 Jun 2017
- Primary completion15 Jan 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Characterize and Compare Clinical, Pathological and Molecular FeaturesStudies 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
- 70 participants (actual)
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
- NCT03378947
- Sponsor's protocol ID
- Hospices civils de lyon
- Status last verified
- Feb 2019
- First submitted
- 14 Dec 2017
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EBV-associated Diffuse Large B Cell Lymphoma NOS in Non Immunocompromised Patients : a French Retrospective Case Study
- ClinicalTrials.gov ID
- NCT03378947
- Acronym / sponsor ID
- Hospices civils de lyon
- Keywords
- EBV, DLBCL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 20 Dec 2017 (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.
The aim of this study is to characterize and compare clinical, pathological (histology, immunophenotype) and molecular features of EBV-related GZL and DLBCL: do they belong to the same entity or to two different subtypes of EBV-related lymphoma ?
Detailed description
Recent progresses in the understanding of lymphoma biology allowed the identification of new categories in the WHO classification of lymphoid neoplasm. Among these new entities, grey zone lymphoma (GZL) between classical Hodgkin lymphoma and diffuse large B cell lymphoma entered the classification as a provisional entity in 2008 and Diffuse large B cell lymphoma (DLBCL) EBV-associated not otherwise specified in patient without history of immunodepression in 2016. These entities need however to be further characterized as no clear pathological definition and distinction between EBV related GZL and EBV related DLBCL are proposed in the literature.
After primary infection that occurs in almost 80% of young adult population in western country, EBV latency state settles in a small portion of B cells. The virus is known to promote B-cells proliferation and transformation through complex mechanisms.
EBV-associated lymphoproliferative disorders have already been largely studied in immunocompromised host (human immunodeficiency virus, congenital immunodeficiency, immunosuppressor and post-transplant lymphoproliferative disorder, e.g.), but its role is largely unknown in patients with no history of immunodeficiency. Whether these patients arbor an underlying type of immune deficiency has not yet been established, even though immunosenecence in elderly or immaturity of the immune system in children has been postulated in those population.
Based on former definition, EBV-associated lymphoproliferation were usually the apanage of classical Hodgkin lymphoma (cHL) or immunodeficiency-associated lymphoproliferative disorders. However, as published recently, several different histological patterns with intermediate features between primary mediastinal B cell lymphoma (PMBCL) and classical Hodgkin lymphoma (cHL), namely grey zone lymphoma (GZL), but also diffuse large B cell lymphoma (DLBCL) were described to be EBV-associated. On the clinical point of view, patients with GZL are young and have a poor prognosis. Data regarding EBV+ DLBCL are discordant and further studies are warranted, even though initial report concluded to a poor prognosis for these patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators will retrospectively collect clinical and pathological data of all EBV-related GZL and DLBCL in immunocompetent patients diagnosed in the pathology department Centre Hospitalier Lyon Sud since 2000.
Key inclusion criteria (2 listed)
- all EBV-related GZL and DLBCL in immunocompetent patients
- Age minimum: 18 years old
Key exclusion criteria (2 listed)
- Another diagnosis than EBV-related GZL and DLBCL
- <18 years old
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 |
|---|---|---|
| clinical and pathological data EBV-related GZL and DLBCLInvesrigators will retrospectively collect clinical and pathological data of all EBV-related GZL and DLBCL in immunocompetent patients diagnosed in the pathology department Centre Hospitalier Lyon Sud. Investigators will analyze their clinical feature and prognosis. | Other | – |
Primary outcome
status at last follow up
Time frame: up to 48 months
Investigators will retrospectively collect clinical and pathological data of all EBV-related GZL and DLBCL in immunocompetent patients diagnosed in the pathology department Centre Hospitalier Lyon Sud.- Clinical data will be extracted from medical records, outcome and status at last follow up.
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 22 Feb 2019.
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.
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 To Characterize and Compare Clinical, Pathological and Molecular Features, 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 2 inclusion and 2 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 22 Feb 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?
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?
status at last follow up (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 22 Feb 2019.