Primary Sjögren SyndromepSSNCT03765593
Biomarkers in Primary Sjögren's Syndrome
An observational study of Primary Sjögren Syndrome and Lymphoma, Non-Hodgkin, run by National Council of Scientific and Technical Research, Argentina.
Trial summary
The clinical spectrum of primary Sjogren Syndrome (pSS)ranges from sicca syndrome to systemic involvement (extraglandular manifestations), including a large number of manifestations that may be the form of presentation or appear after the disease is diagnosed, and that clearly mark the prognosis of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sjögren Syndrome, Lymphoma, Non-Hodgkin
- What is being tested?
- Biopsy Salivary Gland
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Mar 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: Participants with sicca and primary Sjogren Syndrome will be recruited from multiple sites.
Who may be able to join
- Patients: cross sectionally patients will be included for clinical suspicion of primary SS or with the diagnosis already established in Rheumatology unit.
- The following inclusion criteria will be applied to the study:
- Age > 18 years
- Informed consent of the patient.
Who cannot join
- Impossibility of obtaining consent (cognitive impairment, other causes).
- Associated systemic autoimmune or rheumatological diseases.
- Chronic viral infections (HCV, HBV, HIV).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Gene Expression of Interferon (INF) and B Lymphocyte Biomarkers as Markers of Systemic Affectation and Lymphoproliferative Disease in Primary Sjögren's Syndrome
The clinical spectrum of primary Sjogren Syndrome (pSS)ranges from sicca syndrome to systemic involvement (extraglandular manifestations), including a large number of manifestations that may be the form of presentation or appear after the disease is diagnosed, and that clearly mark the prognosis of the disease.
Gene expression levels of Interferon (INF) and B Lymphocyte Biomarkers as Markers of Systemic Affectation and Lymphoproliferative Disease in, together with clinical and laboratory parameters, will provide significant information about the risk of developing hematological neoplasms in patients with pSS at different stages of the disease, and lead to better management of the disease treatment and therapeutic behaviors.
Using the proposed technique allows us to study the gene expression at the mRNA level of each biomarker, which allows us to anticipate the irreversible changes that take place due to the progress of the pathology in progress, since the molecular changes precede the histological changes and in the pathological diagnosis.
Read the detailed description
This project, address the value of these proposed biomarkers in pSS with regard to disease activity and risk stratification of pSS subsets. The investigator's group aim to determine if the proposed biomarkers and their gene expression in saliva, peripheral blood and minor salivary gland samples in patients with pSS are increased to know the degree of their usefulness in daily clinical practice, to indicate which patients have a highest risk of developing a hematological malignancy and to know if these biomarkers are useful to recognize patients who have greater activity of the disease to be able to use it in the follow-up of the disease and as a future responder of the new biological therapies against B cells, INF and monocytes.
Gene expression is a highly regulated mechanism that controls the function and adaptability of all living cells. The field of gene expression analysis has undergone important advances in biomedical research. Today, quantification techniques of mRNA expression have led to improvements in the identification of the gene and the sub-classification of the disease, for example, the expression of specific genes (mRNA) can be quantified by reverse transcription and PCR in quantitative real time. This is the most sensitive technique available to detect and quantify mRNA, where extremely small sample sizes can be used in mRNA quantification. Molecular changes precede histological changes and clinicians in the diagnosis of a pathology. For this reason, studying gene expression at the mRNA level allows us to anticipate irreversible changes that take place due to the progress of the pathology in progress.
- Conditions
- Primary Sjögren Syndrome, Lymphoma, Non-Hodgkin
- Being tested
- Biopsy Salivary Gland
- Keywords
- Primary Sjogren Syndrome, Lymphoma, Biomarker
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy Salivary GlandProcedure or surgery
A minor salivary gland biopsy will be performed at lower lip, with the minimally invasive technique that is carried out in Rheumatology Unit as a routine procedure for the diagnosis of pSS, from there it will be taken between 2-3 glands for the study. RNAlater®(Ambion, Inc., Texas, United States of America) will be stored in solution for the stabilization and preservation of RNA at -80ºC.
| Study group | Role | What they receive |
|---|---|---|
| Study group 1 | Immunopositive primary SS (Anti-SSA +/anti-Ro+) will receive salivary gland biopsy. Receives: Procedure: Biopsy Salivary Gland | |
| Study group 2 | Immunonegative primary SS (Anti-SSA -/anti Ro-, biopsy Chisholm-Mason 3-4) will receive salivary gland biopsy. Receives: Procedure: Biopsy Salivary Gland | |
| Study group 3 | Non-autoimmune sicca syndrome (Anti-SSA/anti Ro-, biopsy Chisholm-Mason 2 o less) will receive salivary gland biopsy. Receives: Procedure: Biopsy Salivary Gland | |
| Control group | Patients who have sicca syndrome but do not meet the classification criteria of Sjögren's syndrome, therefore, at the time of evaluating these patients to determine whether or not they have the disease are what will serve as controls since according to the usual diagnostic process, the same studies will be carried out as for patients with the proposed disease. Will receive salivary gland biopsy. Receives: Procedure: Biopsy Salivary Gland |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression levels in immune cells in salivary gland biopsy samples from participants with and without pSS
To identify a biomarker of disease activity, measured by the real-time PCR reactions (qRT-PCR).
Measured: Up to 24 months
Gene expression levels in immune cells in blood samples from participants with and without pSS
To identify a biomarker of disease activity, measured by the real-time PCR reactions (qRT-PCR).
Measured: Up to 24 months
Gene expression levels in immune cells in saliva samples from participants with and without pSS
To identify a biomarker of disease activity, measured by the real-time PCR reactions (qRT-PCR).
Measured: Up to 24 months
Secondary outcomes (4)
Immunoglobulins
The change from baseline in IgG, IgM and IgA levels at 24 months.
Measured: Up to 24 months
Complement levels C3 and C4
The change from baseline in complement levels at 24 months.
Measured: Up to 24 months
Rheumatoid Factor
The change from baseline in titer of rheumatoid factors at 24 months.
Measured: Up to 24 months
Cryoglobulins
The change from baseline in titer of cryoglobulins at 24 months.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study startMar 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Primary Sjögren SyndromeStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Council of Scientific and Technical Research, Argentina
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maria Soledad Retamozo, National Council of Scientific and Technical Research, Argentina
- Investigators
- Maria Soledad Retamozo, MD, PhD, Principal investigator, INICSA-Universidad Nacional de Córdoba-CONICET, Córdoba, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765593
- Sponsor's protocol ID
- 3398
- Acronym
- pSS
- Status last verified
- Dec 2018
- First submitted
- 20 Nov 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Retamozo S, Flores-Chavez A, Consuegra-Fernandez M, Lozano F, Ramos-Casals M, Brito-Zeron P. Cytokines as therapeutic targets in primary Sjogren syndrome. Pharmacol Ther. 2018 Apr;184:81-97. doi: 10.1016/j.pharmthera.2017.10.019. Epub 2017 Oct 29.
PubMed 29092775Kassan SS, Thomas TL, Moutsopoulos HM, Hoover R, Kimberly RP, Budman DR, Costa J, Decker JL, Chused TM. Increased risk of lymphoma in sicca syndrome. Ann Intern Med. 1978 Dec;89(6):888-92. doi: 10.7326/0003-4819-89-6-888.
PubMed 102228Jonsson R, Gordon TP, Konttinen YT. Recent advances in understanding molecular mechanisms in the pathogenesis and antibody profile of Sjogren's syndrome. Curr Rheumatol Rep. 2003 Aug;5(4):311-6. doi: 10.1007/s11926-003-0010-z.
PubMed 14531959Ioannidis JP, Vassiliou VA, Moutsopoulos HM. Long-term risk of mortality and lymphoproliferative disease and predictive classification of primary Sjogren's syndrome. Arthritis Rheum. 2002 Mar;46(3):741-7. doi: 10.1002/art.10221.
PubMed 11920410Brito-Zeron P, Retamozo S, Gheitasi H, Ramos-Casals M. Erratum to: Treating the Underlying Pathophysiology of Primary Sjogren Syndrome: Recent Advances and Future Prospects. Drugs. 2016 Dec;76(18):1799. doi: 10.1007/s40265-016-0669-x. No abstract available.
PubMed 27905085Rose T, Grutzkau A, Hirseland H, Huscher D, Dahnrich C, Dzionek A, Ozimkowski T, Schlumberger W, Enghard P, Radbruch A, Riemekasten G, Burmester GR, Hiepe F, Biesen R. IFNalpha and its response proteins, IP-10 and SIGLEC-1, are biomarkers of disease activity in systemic lupus erythematosus. Ann Rheum Dis. 2013 Oct;72(10):1639-45. doi: 10.1136/annrheumdis-2012-201586. Epub 2012 Oct 31.
PubMed 23117242Martin T, Weber JC, Levallois H, Labouret N, Soley A, Koenig S, Korganow AS, Pasquali JL. Salivary gland lymphomas in patients with Sjogren's syndrome may frequently develop from rheumatoid factor B cells. Arthritis Rheum. 2000 Apr;43(4):908-16. doi: 10.1002/1529-0131(200004)43:43.0.CO;2-K.
PubMed 10765938Quartuccio L, Baldini C, Bartoloni E, Priori R, Carubbi F, Corazza L, Alunno A, Colafrancesco S, Luciano N, Giacomelli R, Gerli R, Valesini G, Bombardieri S, De Vita S. Anti-SSA/SSB-negative Sjogren's syndrome shows a lower prevalence of lymphoproliferative manifestations, and a lower risk of lymphoma evolution. Autoimmun Rev. 2015 Nov;14(11):1019-22. doi: 10.1016/j.autrev.2015.07.002. Epub 2015 Jul 8.
PubMed 26162302Quartuccio L, Salvin S, Fabris M, Maset M, Pontarini E, Isola M, De Vita S. BLyS upregulation in Sjogren's syndrome associated with lymphoproliferative disorders, higher ESSDAI score and B-cell clonal expansion in the salivary glands. Rheumatology (Oxford). 2013 Feb;52(2):276-81. doi: 10.1093/rheumatology/kes180. Epub 2012 Aug 9.
PubMed 22879463Moore PA, Belvedere O, Orr A, Pieri K, LaFleur DW, Feng P, Soppet D, Charters M, Gentz R, Parmelee D, Li Y, Galperina O, Giri J, Roschke V, Nardelli B, Carrell J, Sosnovtseva S, Greenfield W, Ruben SM, Olsen HS, Fikes J, Hilbert DM. BLyS: member of the tumor necrosis factor family and B lymphocyte stimulator. Science. 1999 Jul 9;285(5425):260-3. doi: 10.1126/science.285.5425.260.
PubMed 10398604Schneider P, MacKay F, Steiner V, Hofmann K, Bodmer JL, Holler N, Ambrose C, Lawton P, Bixler S, Acha-Orbea H, Valmori D, Romero P, Werner-Favre C, Zubler RH, Browning JL, Tschopp J. BAFF, a novel ligand of the tumor necrosis factor family, stimulates B cell growth. J Exp Med. 1999 Jun 7;189(11):1747-56. doi: 10.1084/jem.189.11.1747.
PubMed 10359578Mariette X, Roux S, Zhang J, Bengoufa D, Lavie F, Zhou T, Kimberly R. The level of BLyS (BAFF) correlates with the titre of autoantibodies in human Sjogren's syndrome. Ann Rheum Dis. 2003 Feb;62(2):168-71. doi: 10.1136/ard.62.2.168.
PubMed 12525388Theander E, Vasaitis L, Baecklund E, Nordmark G, Warfvinge G, Liedholm R, Brokstad K, Jonsson R, Jonsson MV. Lymphoid organisation in labial salivary gland biopsies is a possible predictor for the development of malignant lymphoma in primary Sjogren's syndrome. Ann Rheum Dis. 2011 Aug;70(8):1363-8. doi: 10.1136/ard.2010.144782.
PubMed 21715359Lavie F, Miceli-Richard C, Quillard J, Roux S, Leclerc P, Mariette X. Expression of BAFF (BLyS) in T cells infiltrating labial salivary glands from patients with Sjogren's syndrome. J Pathol. 2004 Apr;202(4):496-502. doi: 10.1002/path.1533.
PubMed 15095277Szodoray P, Alex P, Jonsson MV, Knowlton N, Dozmorov I, Nakken B, Delaleu N, Jonsson R, Centola M. Distinct profiles of Sjogren's syndrome patients with ectopic salivary gland germinal centers revealed by serum cytokines and BAFF. Clin Immunol. 2005 Nov;117(2):168-76. doi: 10.1016/j.clim.2005.06.016. Epub 2005 Aug 26.
PubMed 16126006
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression of Interferon (INF) and B Lymphocyte Biomarkers as Markers of Systemic Affectation and Lymphoproliferative Disease in Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT03765593
- Acronym / sponsor ID
- pSS / 3398
- Conditions
- Primary Sjögren Syndrome, Lymphoma, Non-Hodgkin
- Keywords
- Primary Sjogren Syndrome, Lymphoma, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Council of Scientific and Technical Research, ArgentinaOther government
- Study start
- Mar 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 5 Dec 2018 (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 clinical spectrum of primary Sjogren Syndrome (pSS)ranges from sicca syndrome to systemic involvement (extraglandular manifestations), including a large number of manifestations that may be the form of presentation or appear after the disease is diagnosed, and that clearly mark the prognosis of the disease.
Gene expression levels of Interferon (INF) and B Lymphocyte Biomarkers as Markers of Systemic Affectation and Lymphoproliferative Disease in, together with clinical and laboratory parameters, will provide significant information about the risk of developing hematological neoplasms in patients with pSS at different stages of the disease, and lead to better management of the disease treatment and therapeutic behaviors.
Using the proposed technique allows us to study the gene expression at the mRNA level of each biomarker, which allows us to anticipate the irreversible changes that take place due to the progress of the pathology in progress, since the molecular changes precede the histological changes and in the pathological diagnosis.
Detailed description
This project, address the value of these proposed biomarkers in pSS with regard to disease activity and risk stratification of pSS subsets. The investigator's group aim to determine if the proposed biomarkers and their gene expression in saliva, peripheral blood and minor salivary gland samples in patients with pSS are increased to know the degree of their usefulness in daily clinical practice, to indicate which patients have a highest risk of developing a hematological malignancy and to know if these biomarkers are useful to recognize patients who have greater activity of the disease to be able to use it in the follow-up of the disease and as a future responder of the new biological therapies against B cells, INF and monocytes.
Gene expression is a highly regulated mechanism that controls the function and adaptability of all living cells. The field of gene expression analysis has undergone important advances in biomedical research. Today, quantification techniques of mRNA expression have led to improvements in the identification of the gene and the sub-classification of the disease, for example, the expression of specific genes (mRNA) can be quantified by reverse transcription and PCR in quantitative real time. This is the most sensitive technique available to detect and quantify mRNA, where extremely small sample sizes can be used in mRNA quantification. Molecular changes precede histological changes and clinicians in the diagnosis of a pathology. For this reason, studying gene expression at the mRNA level allows us to anticipate irreversible changes that take place due to the progress of the pathology in progress.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | – | Procedure: Biopsy Salivary GlandImmunopositive primary SS (Anti-SSA +/anti-Ro+) will receive salivary gland biopsy. |
| Study group 2 | – | Procedure: Biopsy Salivary GlandImmunonegative primary SS (Anti-SSA -/anti Ro-, biopsy Chisholm-Mason 3-4) will receive salivary gland biopsy. |
| Study group 3 | – | Procedure: Biopsy Salivary GlandNon-autoimmune sicca syndrome (Anti-SSA/anti Ro-, biopsy Chisholm-Mason 2 o less) will receive salivary gland biopsy. |
| Control group | – | Procedure: Biopsy Salivary GlandPatients who have sicca syndrome but do not meet the classification criteria of Sjögren's syndrome, therefore, at the time of evaluating these patients to determine whether or not they have the disease are what will serve as controls since according to the usual diagnostic process, the same studies will be carried out as for patients with the proposed disease. Will receive salivary gland biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with sicca and primary Sjogren Syndrome will be recruited from multiple sites.
Key inclusion criteria (4 listed)
- Patients: cross sectionally patients will be included for clinical suspicion of primary SS or with the diagnosis already established in Rheumatology unit.
- Age > 18 years
- Informed consent of the patient.
Key exclusion criteria (3 listed)
- Impossibility of obtaining consent (cognitive impairment, other causes).
- Associated systemic autoimmune or rheumatological diseases.
- Chronic viral infections (HCV, HBV, HIV).
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 |
|---|---|---|
| Biopsy Salivary GlandA minor salivary gland biopsy will be performed at lower lip, with the minimally invasive technique that is carried out in Rheumatology Unit as a routine procedure for the diagnosis of pSS, from there it will be taken between 2-3 glands for the study. RNAlater®(Ambion, Inc., Texas, United States of America) will be stored in solution for the stabilization and preservation of RNA at -80ºC. | Procedure or surgery | Control group, Study group 1, Study group 2, Study group 3 |
Primary outcome
Gene expression levels in immune cells in salivary gland biopsy samples from participants with and without pSS
Time frame: Up to 24 months
To identify a biomarker of disease activity, measured by the real-time PCR reactions (qRT-PCR).
Gene expression levels in immune cells in blood samples from participants with and without pSS
Time frame: Up to 24 months
To identify a biomarker of disease activity, measured by the real-time PCR reactions (qRT-PCR).
Gene expression levels in immune cells in saliva samples from participants with and without pSS
Time frame: Up to 24 months
To identify a biomarker of disease activity, measured by the real-time PCR reactions (qRT-PCR).
4 secondary outcomes
Immunoglobulins
Time frame: Up to 24 months
Complement levels C3 and C4
Time frame: Up to 24 months
Rheumatoid Factor
Time frame: Up to 24 months
Cryoglobulins
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Background: PubMed 29092775Retamozo S, Flores-Chavez A, Consuegra-Fernandez M, Lozano F, Ramos-Casals M, Brito-Zeron P. Cytokines as therapeutic targets in primary Sjogren syndrome. Pharmacol Ther. 2018 Apr;184:81-97. doi: 10.1016/j.pharmthera.2017.10.019. Epub 2017 Oct 29.
- Background: PubMed 102228Kassan SS, Thomas TL, Moutsopoulos HM, Hoover R, Kimberly RP, Budman DR, Costa J, Decker JL, Chused TM. Increased risk of lymphoma in sicca syndrome. Ann Intern Med. 1978 Dec;89(6):888-92. doi: 10.7326/0003-4819-89-6-888.
- Background: PubMed 14531959Jonsson R, Gordon TP, Konttinen YT. Recent advances in understanding molecular mechanisms in the pathogenesis and antibody profile of Sjogren's syndrome. Curr Rheumatol Rep. 2003 Aug;5(4):311-6. doi: 10.1007/s11926-003-0010-z.
- Background: PubMed 11920410Ioannidis JP, Vassiliou VA, Moutsopoulos HM. Long-term risk of mortality and lymphoproliferative disease and predictive classification of primary Sjogren's syndrome. Arthritis Rheum. 2002 Mar;46(3):741-7. doi: 10.1002/art.10221.
- Background: PubMed 27905085Brito-Zeron P, Retamozo S, Gheitasi H, Ramos-Casals M. Erratum to: Treating the Underlying Pathophysiology of Primary Sjogren Syndrome: Recent Advances and Future Prospects. Drugs. 2016 Dec;76(18):1799. doi: 10.1007/s40265-016-0669-x. No abstract available.
- Background: PubMed 23117242Rose T, Grutzkau A, Hirseland H, Huscher D, Dahnrich C, Dzionek A, Ozimkowski T, Schlumberger W, Enghard P, Radbruch A, Riemekasten G, Burmester GR, Hiepe F, Biesen R. IFNalpha and its response proteins, IP-10 and SIGLEC-1, are biomarkers of disease activity in systemic lupus erythematosus. Ann Rheum Dis. 2013 Oct;72(10):1639-45. doi: 10.1136/annrheumdis-2012-201586. Epub 2012 Oct 31.
- Results publication: PubMed 10765938Martin T, Weber JC, Levallois H, Labouret N, Soley A, Koenig S, Korganow AS, Pasquali JL. Salivary gland lymphomas in patients with Sjogren's syndrome may frequently develop from rheumatoid factor B cells. Arthritis Rheum. 2000 Apr;43(4):908-16. doi: 10.1002/1529-0131(200004)43:43.0.CO;2-K.
- Results publication: PubMed 26162302Quartuccio L, Baldini C, Bartoloni E, Priori R, Carubbi F, Corazza L, Alunno A, Colafrancesco S, Luciano N, Giacomelli R, Gerli R, Valesini G, Bombardieri S, De Vita S. Anti-SSA/SSB-negative Sjogren's syndrome shows a lower prevalence of lymphoproliferative manifestations, and a lower risk of lymphoma evolution. Autoimmun Rev. 2015 Nov;14(11):1019-22. doi: 10.1016/j.autrev.2015.07.002. Epub 2015 Jul 8.
- Results publication: PubMed 22879463Quartuccio L, Salvin S, Fabris M, Maset M, Pontarini E, Isola M, De Vita S. BLyS upregulation in Sjogren's syndrome associated with lymphoproliferative disorders, higher ESSDAI score and B-cell clonal expansion in the salivary glands. Rheumatology (Oxford). 2013 Feb;52(2):276-81. doi: 10.1093/rheumatology/kes180. Epub 2012 Aug 9.
- Results publication: PubMed 10398604Moore PA, Belvedere O, Orr A, Pieri K, LaFleur DW, Feng P, Soppet D, Charters M, Gentz R, Parmelee D, Li Y, Galperina O, Giri J, Roschke V, Nardelli B, Carrell J, Sosnovtseva S, Greenfield W, Ruben SM, Olsen HS, Fikes J, Hilbert DM. BLyS: member of the tumor necrosis factor family and B lymphocyte stimulator. Science. 1999 Jul 9;285(5425):260-3. doi: 10.1126/science.285.5425.260.
- Results publication: PubMed 10359578Schneider P, MacKay F, Steiner V, Hofmann K, Bodmer JL, Holler N, Ambrose C, Lawton P, Bixler S, Acha-Orbea H, Valmori D, Romero P, Werner-Favre C, Zubler RH, Browning JL, Tschopp J. BAFF, a novel ligand of the tumor necrosis factor family, stimulates B cell growth. J Exp Med. 1999 Jun 7;189(11):1747-56. doi: 10.1084/jem.189.11.1747.
- Results publication: PubMed 12525388Mariette X, Roux S, Zhang J, Bengoufa D, Lavie F, Zhou T, Kimberly R. The level of BLyS (BAFF) correlates with the titre of autoantibodies in human Sjogren's syndrome. Ann Rheum Dis. 2003 Feb;62(2):168-71. doi: 10.1136/ard.62.2.168.
- 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.
Maria Soledad Retamozo, MD, PhD principal investigator
INICSA-Universidad Nacional de Córdoba-CONICET, Córdoba, Argentina
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Sjögren Syndrome and Lymphoma, Non-Hodgkin, run by National Council of Scientific and Technical Research, Argentina.
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 4 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 5 Dec 2018. 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?
Contact Maria Soledad Retamozo, MD, PhD (005493516981622, soleretamozo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression levels in immune cells in salivary gland biopsy samples from participants with and without pSS (time frame: Up to 24 months). The study lists 3 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 NCT03765593, which also lists 22 linked publications.
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 5 Dec 2018.