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RecruitingNCT05780099MED-CliUpdated Jun 22, 2025

Prospective Observational Study to Characterize Patients Treated at Internal Medicine Clinics

An observational study in Respiratory Disease, Cardiovascular Diseases and Infectious Disease, sponsored by IRCCS San Raffaele. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-22.

Sponsored by IRCCS San Raffaele · Observational

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Respiratory Disease
  • Cardiovascular Diseases
  • Infectious Disease
  • Critical Illness
  • Immunological Disease
  • Pregnancy Disease
  • Metabolic Syndrome
  • Chronic Disease
03

In context

Communicable Diseases

4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's planned enrollment of 50,000 is above the median of 244 across 1,499 observational studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated in outpatient, inpatient or day hospital setting of internal medicine units at San Raffaele Hospital

Inclusion criteria

  • Receving treatment at internal medicine departments (inpatient, outopatient, day hospital) of San Raffaele Hospital
  • at least one suspected or confirmed diagnosis among:

    1. immune mediated disorder
    2. respiratory disorder
    3. metabolic disorder
    4. sepsis
    5. rare disorder (according to Italian Ministry of Health list)
    6. pregnancy-related disorder
    7. frailty defined as: either ≥2 CIRS (Cumulative Illness Rating Scale) Severity Index 10 or ≤70% Karnofsky scale

Exclusion criteria

Exclusion Criteria:

  • refusal to participate
  • enrolment in other intervantional study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cases

    patients treated at internal medicine wards

    Other: Inpatient or Outpatient visit

Interventions

  • OtherInpatient or Outpatient visit

    Patients will be seen and treated at the clinics like in the usual care

06

What researchers measure

Primary outcomes

  1. Number of participants with severe disease

    Identify demographic, clinical, laboratory and radiological markers of disease severity and activity

    Time frame: The following variables will be collected during patient enrollment

07

Study locations

2 of 2 sites recruiting
  • Ospedale San Raffaele
    Milan, Italy
    Recruiting
  • San Raffaele Hospital
    Milan, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05780099
Lead sponsor
IRCCS San Raffaele
Responsible party
Rovere Querini Patrizia (Director, IRCCS San Raffaele) — Principal investigator
First posted
Mar 22, 2023
Start date
Jun 24, 2022
Primary completion
Sep 10, 2031 (estimated)
Completion
Sep 10, 2032 (estimated)
Last update
Jun 22, 2025

Study contacts

Patrizia Rovere Querini, PhD, MD
Contact
rovere.patrizia@hsr.it
+390226436095
Rebecca De Lorenzo, MD
Contact
delorenzo.rebecca@hsr.it
+390226433065

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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