Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05780099 |
| Other study ID # |
MED-Cli |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 24, 2022 |
| Est. completion date |
September 10, 2032 |
Study information
| Verified date |
March 2024 |
| Source |
IRCCS San Raffaele |
| Contact |
Patrizia Rovere Querini, PhD, MD |
| Phone |
+390226436095 |
| Email |
rovere.patrizia[@]hsr.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Patients referred to internal medicine wards are becoming increasingly complex and fragile.
Despite deep knowledge of their specific disorders, steps are required to improve overall
management of their acute and chronic conditions. The main objective of the study is to
identify demographic, clinical, laboratory and radiological markers of disease severity and
activity in patients with diseases treated at general medicine wards (respiratory disease,
immune-mediated disease, sepsis, metabolic disease, rare disease, frailty, pregnancy
pathology) in order to improve their diagnosis, monitoring and treatment processes.
Description:
Among the most prevalent internal diseases worldwide are metabolic, respiratory and
infectious diseases. Despite important progress in the field of these diseases, their
frequent coexistence leads to a state of so-called fragility, now recognised as a genuine
pathological condition, and entails the need to optimise their management in order to ensure
faster and more effective diagnostic processes and targeted treatment procedures. On the
other hand, those less frequent and less defined from both a pathogenetic and a management
point of view include immune-mediated diseases, rare diseases, and internist disorders of
pregnancy. Many times, diagnostic and therapeutic algorithms validated for specific diseases
are arbitrarily applied to less common diseases based on the similarity of the clinical
picture. For example, indices of inflammation such as C-reactive protein and erythrocyte
sedimentation rate, traditionally used as markers of inflammatory response to infection, are
commonly used as surrogate markers of disease activity in non-infectious immune-mediated
diseases, despite the fact that there are no studies demonstrating their specific usefulness
in patients suffering from them. This often leads to inappropriate care choices, as they are
not based on sufficient degrees of evidence for those specific diseases. Studies focusing on
specific disease categories are necessary to identify disease-specific markers and thus
target therapy in an informed manner. Both the most prevalent and the least characterised
pathologies require the integrated work of third-level centres, such as the San Raffaele
Hospital, which have a large number of patient referrals and can therefore make a concrete
contribution to the advancement of knowledge of these pathologies and their management and
make their mark in the international scientific community. To this end, a prospective
observational study is being conducted aimed at the detailed characterisation of patients
suffering from these pathologies, in order to identify possible risk factors and markers of
severity that can guide the development of new diagnostic and therapeutic strategies.
