NCT05712967Completed
Role of the Host Microbiota and Il-17 in Favoring Multiple Myeloma Progression
Source: ClinicalTrials.gov · Last updated 1 Mar 2024
Brief summary (registry, in English)
Goal of this observational, non-interventional study is to demonstrate that in humans a correlation exists between bone marrow (BM) levels of the cytokine interleukin 17 (IL-17) and composition of the gut microbiota in patients affected by smoldering multiple myeloma (SMM) or multiple myeloma (MM). Enrolled SMM/MM patients will be analyzed for their bone marrow levels of IL-17 together with the distribution of T helper 17 lymphocytes in their BM and peripheral blood. These analyses will be correlated with analyses of the patients' gut microbiome to identify commensal bacteria potentially involved in Th17 cell expansion.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 62 (actual)
- First submitted
- 23 Dec 2022
- Start date
- 14 Jun 2019
- Primary completion date
- 5 Feb 2024
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Multiple myeloma
- NCT number
- NCT05712967
What you commit to
- Study type: Observational
- Participants enrolled: 62
- From 14 Jun 2019 to the primary completion date, 5 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects reporting infectious diseases requiring antibiotic therapy in the previous three months, ongoing antibiotic therapy or prophylaxis.
- Subjects who already underwent HSCT or under pharmacologic therapy for MM.
Other illness
- Subjects affected by autoimmune diseases with the exception of thyroiditis.
- Subjects affected by HIV, HBV or HCV.
Age
- Subjects younger than 18 years.
Other
- Non-Caucasian subjects.
- Subjects that did not accept to sign the informed consent.
Who the study is looking for
- patients fulfilling the International Myeloma Working Group (IMWG) diagnostic criteria for SMM or MM, and 10 healthy controls older than 18 years and accepting to sign the informed consent
Age in the registry: 18 years to 80 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.