An observational study in Diffuse Large B Cell Lymphoma, sponsored by University of Bologna. Status unknown at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by University of Bologna · Observational
In Europe diffuse large B-cell lymphoma (DLBCL) is a rare disease whereas in Italy it is not. Approximately 40% of DLBCL patients has refractory disease or will relapse after initial response. In onco-hematology, a role for gut microbiota (GM) in mediating immune activation in response to chemotherapy, has been suggested. In this scenario, the Investigators hypothesized that GM could play an important role in DLBCL prognosis and response to treatment, establishing a connection between lifestyle and clinical response. The project is aimed to the study of the functional GM layout in association with specific patterns of treatment response in de novo DLBCL undergoing standard first line chemo-immunotherapy. Results may build the scientific basis to design new and personalized intervention strategies (both in treatment approach and in life-style recommendations), to enhance clinical response and reduction of disease refractoriness through modulation of the gut microbial ecosystem.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 50 is below the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →University of Bologna is the lead sponsor of 153 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients affected by diffuse large B-cell lymphoma (DLBCL) undergoing therapy with front-line R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone).
Exclusion Criteria:
Gut microbiota analysis from diagnosis to follow up after first line-chemo-immuntherapy
GM dysbiosis assessment (bacterial DNA of gut microbiota in all patients)
* dysbiosis index: the dysbiosis index relies on the calculation of the weighted ratio between health-promoting and disease-associated GM components * relative abundance of GM biomarkers of an eubiotic GM state: all GM dysbiotic states share a common feature, i.e. the depletion of strategic health-promoting GM components such as Faecalibacterium prausnitzii and Lachnospiraceae. Thus, a GM dysbiotic state is determined by the assessment of a reduction of the abundance of these GM biomarkers below the thresholds characteristic of an eubiotc GM state.
Time frame: 18 months
Response to therapy
Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET negative and all lymph nodes and nodal masses must have regressed on CT to normal size ( 1.5 cm in their greatest transverse diameter for nodes 1.5 cm before therapy).
Time frame: 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Bologna