Follicular LymphomaNCT02978898
CD180 Overexpression in Follicular Lymphoma
An observational study of Follicular Lymphoma, run by Hospices Civils de Lyon.
Trial summary
Background:Altered Toll-like receptor (TLR) expression levels and/or mutations in its signaling pathway (such as MyD88 mutation) contribute to the pathogenesis of lymphoproliferative disorders (LPD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Follicular Lymphoma
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jun 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 99 LN (lymph nodes) and 65 PB (peripheral blood) samples obtained from patients diagnosed with LPDs in our institution between 2012 and 2014 were evaluated for CD180 expression by FCM. The diagnosis were made according to the WHO 2008 classification, including clinical and morphological analysis, immunophenotyping, and conventional and molecular cytogenetics (and/or fluorescent in situ hybridization). The diagnoses were follicular lymphoma (FL) (LN, n=44; PB, n=15), small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL)/CLL (LN, n=26; PB, n=21), MCL (LN, n=13; PB,n=17), and MZL (LN, n=16; PB, n=12). All PB samples presented circulating neoplastic B-cells, and in several cases, the diagnosis was made at the same time in LN and PB FL, n=4; SLL/CLL, n=18; MCL, n=5. MZL, n=6.
Who may be able to join
- Samples from patients with:
- LF: Follicular lymphoma
- MCL: Mantle cell lymphoma
- CLL/SLL: chronic lymphocytic leukemia/small lymphocytic leukemia
- MZL : splenic marginal zone
- Clt :control B-cells
Who cannot join
- Patient <18 years old
About this study
Official title: CD180 Overexpression in Follicular Lymphoma Is Restricted to the Lymph Node Compartment
Background:Altered Toll-like receptor (TLR) expression levels and/or mutations in its signaling pathway (such as MyD88 mutation) contribute to the pathogenesis of lymphoproliferative disorders (LPD). CD180 is an orphan member of the TLR family that modulates the signaling of several TLRs, but only limited studies have evaluated its expression by flow cytometry (FCM) in LPD.
Methods: Using a multiparameter FCM approach, biologists have assessed CD180 mean fluorescence intensity (MFI) in lymph nodes (LNs) and peripheral blood (PB) samples obtained from patients with follicular lymphoma (FL; LN/PB, n=44/n=15), chronic lymphocytic leukemia (CLL, n=26/n=21), mantle cell lymphoma (MCL, n=13/n=17), and marginal zone lymphoma (MZL, n=16/n=12). Specimens from non-tumoral PB and LN (n=8/n=12) were used as controls.
- Conditions
- Follicular Lymphoma
- Keywords
- Follicular Lymphoma, flow cytometry, CD180, Toll-like receptor, lymphoproliferative disease
- Medical subject headings
- Lymphoma, Follicular, Lymphoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LN Lymph nodes | Samples obtained from patients with : LF: Follicular lymphoma MCL: Mantle cell lymphoma CLL/SLL: chronic lymphocytic leukemia/small lymphocytic leukemia MZL : splenic marginal zone Clt :control B-cells | |
| PB peripheral blood | Samples obtained from patients with : LF: Follicular lymphoma MCL: Mantle cell lymphoma CLL/SLL: chronic lymphocytic leukemia/small lymphocytic leukemia MZL : splenic marginal zone Clt :control B-cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunophenotype Analysis by Flow Cytometry of lymph nodes samples at inclusion
Using a multiparameter FCM approach, biologists assessed the CD180 expression by our routine antigen panel in LN suspensions as well as in PB samples. Samples were analyzed on a BD FACSCanto II cytometer (BD FACS DIVA software; Becton Dickinson, San Jose, CA).
Measured: At inclusion, day 0.
Immunophenotype Analysis by Flow Cytometry of peripheral blood samples at inclusion
Using a multiparameter FCM approach, biologists assessed the CD180 expression by our routine antigen panel in LN suspensions as well as in PB samples. Samples were analyzed on a BD FACSCanto II cytometer (BD FACS DIVA software; Becton Dickinson, San Jose, CA).
Measured: At inclusion, day 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Follicular 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 184 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
- NCT02978898
- Sponsor's protocol ID
- 69HCL16_0564
- Status last verified
- Aug 2016
- First submitted
- 29 Aug 2016
- Last updated
- 1 Dec 2016
- Results posted
- No
Publications
Mestrallet F, Sujobert P, Sarkozy C, Traverse-Glehen A, Callet-Bauchu E, Magaud JP, Salles G, Baseggio L. CD180 overexpression in follicular lymphoma is restricted to the lymph node compartment. Cytometry B Clin Cytom. 2016 Sep;90(5):433-9. doi: 10.1002/cyto.b.21331. Epub 2015 Dec 11.
PubMed 26482097
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD180 Overexpression in Follicular Lymphoma Is Restricted to the Lymph Node Compartment
- ClinicalTrials.gov ID
- NCT02978898
- Acronym / sponsor ID
- 69HCL16_0564
- Conditions
- Follicular Lymphoma
- Keywords
- Follicular Lymphoma, flow cytometry, CD180, Toll-like receptor, lymphoproliferative disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Dec 2016 (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.
Background:Altered Toll-like receptor (TLR) expression levels and/or mutations in its signaling pathway (such as MyD88 mutation) contribute to the pathogenesis of lymphoproliferative disorders (LPD). CD180 is an orphan member of the TLR family that modulates the signaling of several TLRs, but only limited studies have evaluated its expression by flow cytometry (FCM) in LPD.
Methods: Using a multiparameter FCM approach, biologists have assessed CD180 mean fluorescence intensity (MFI) in lymph nodes (LNs) and peripheral blood (PB) samples obtained from patients with follicular lymphoma (FL; LN/PB, n=44/n=15), chronic lymphocytic leukemia (CLL, n=26/n=21), mantle cell lymphoma (MCL, n=13/n=17), and marginal zone lymphoma (MZL, n=16/n=12). Specimens from non-tumoral PB and LN (n=8/n=12) were used as controls.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LN Lymph nodes | – | –Samples obtained from patients with : LF: Follicular lymphoma MCL: Mantle cell lymphoma CLL/SLL: chronic lymphocytic leukemia/small lymphocytic leukemia MZL : splenic marginal zone Clt :control B-cells |
| PB peripheral blood | – | –Samples obtained from patients with : LF: Follicular lymphoma MCL: Mantle cell lymphoma CLL/SLL: chronic lymphocytic leukemia/small lymphocytic leukemia MZL : splenic marginal zone Clt :control B-cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 99 LN (lymph nodes) and 65 PB (peripheral blood) samples obtained from patients diagnosed with LPDs in our institution between 2012 and 2014 were evaluated for CD180 expression by FCM. The diagnosis were made according to the WHO 2008 classification, including clinical and morphological analysis, immunophenotyping, and conventional and molecular cytogenetics (and/or fluorescent in situ hybridization). The diagnoses were follicular lymphoma (FL) (LN, n=44; PB, n=15), small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL)/CLL (LN, n=26; PB, n=21), MCL (LN, n=13; PB,n=17), and MZL (LN, n=16; PB, n=12). All PB samples presented circulating neoplastic B-cells, and in several cases, the diagnosis was made at the same time in LN and PB FL, n=4; SLL/CLL, n=18; MCL, n=5. MZL, n=6.
Key inclusion criteria (6 listed)
- Samples from patients with:
Key exclusion criteria (1 listed)
- Patient <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.
Primary outcome
Immunophenotype Analysis by Flow Cytometry of lymph nodes samples at inclusion
Time frame: At inclusion, day 0.
Using a multiparameter FCM approach, biologists assessed the CD180 expression by our routine antigen panel in LN suspensions as well as in PB samples. Samples were analyzed on a BD FACSCanto II cytometer (BD FACS DIVA software; Becton Dickinson, San Jose, CA).
Immunophenotype Analysis by Flow Cytometry of peripheral blood samples at inclusion
Time frame: At inclusion, day 0.
Using a multiparameter FCM approach, biologists assessed the CD180 expression by our routine antigen panel in LN suspensions as well as in PB samples. Samples were analyzed on a BD FACSCanto II cytometer (BD FACS DIVA software; Becton Dickinson, San Jose, CA).
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 1 Dec 2016.
- Results publication: PubMed 26482097Mestrallet F, Sujobert P, Sarkozy C, Traverse-Glehen A, Callet-Bauchu E, Magaud JP, Salles G, Baseggio L. CD180 overexpression in follicular lymphoma is restricted to the lymph node compartment. Cytometry B Clin Cytom. 2016 Sep;90(5):433-9. doi: 10.1002/cyto.b.21331. Epub 2015 Dec 11.
Related trials for Follicular Lymphoma
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruiting
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Substance Use Disorders, Opioid Use Disorder, Severe
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
Recruiting
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)
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 Follicular Lymphoma, run by Hospices Civils de Lyon.
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 6 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: finished, as of the sponsor's last update on 1 Dec 2016. 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?
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?
Immunophenotype Analysis by Flow Cytometry of lymph nodes samples at inclusion (time frame: At inclusion, day 0.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02978898, which also lists 1 linked publication.
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 Dec 2016.