Clinical trial Recruiting at 1 site Observational Ages 0 to 100

Reference ranges from routine lab data in Italy

Official title: Reference Intervals With Indirect Methods in Italy

Run by Centro di Riferimento Oncologico - Aviano · NCT07433777 · Data updated 2026-11-12

This project tests whether routine clinical lab records can be used to create reference ranges for lab tests so doctors can interpret patient results without recruiting healthy volunteers.

Quick facts

Study typeObservational
Ages0 Years to 100 Years
SexAll
Enrollment1000000 (estimated)
SponsorCentro di Riferimento Oncologico - Aviano
Academic / other
Locations24 sites (Altamura, Altamura and 23 other locations)
StatusRecruiting
StartedOctober 8, 2025
Main results expectedJune 1, 2028
Study endsJune 1, 2028
Registry record updatedFebruary 25, 2026
Trial IDNCT07433777 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

The project uses routine lab results from patients whose tests were performed at participating Italian hospitals and laboratories.

Probably not a fit

People who do not have lab tests recorded at the participating centers or whose data are excluded for privacy or quality reasons would not be part of this work and would not directly benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses existing laboratory and electronic health record data from multiple Italian hospitals to derive reference intervals using indirect statistical methods. Researchers apply algorithms and data-cleaning procedures to isolate likely healthy results from routine clinical datasets and calculate age- and sex-specific reference limits. They compare derived intervals across centers and demographic groups to check consistency and potential biases. This observational approach aims to reduce costs and selection bias associated with recruiting healthy volunteers for direct reference interval studies.

Why it matters

Potential benefit: If successful, this approach could provide accurate, up-to-date reference ranges for many lab tests while lowering costs and including broader patient populations.

How similar studies have gone: Indirect methods have been applied in other countries and shown promising results for many analytes, though performance varies by test and population.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* no one

Exclusion Criteria:

* no one

Where it's running

  • Centro di Riferimento Oncolgico -IRCCS
    Aviano, Pordenone, Italy
    Recruiting
  • ASL Bari, Ospedale della Murgia, Altamura
    Altamura, Altamura, Italy
    Not yet recruiting
  • Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona
    Ancona, Ancona, Italy
    Not yet recruiting
  • Azienda USL Toscana Sud Est, Arezzo
    Arezzo, Arezzo, Italy
    Not yet recruiting
  • Azienda ULSS 1 Dolomiti
    Belluno, Belluno, Italy
    Not yet recruiting
  • Azienda Ospedaliero-Universitaria Careggi, Firenze
    Florence, Firenze, Italy
    Not yet recruiting
Show 18 more locations
  • IRCCS Istituto Clinico Humanitas, Milano
    Milan, Milano, Italy
    Not yet recruiting
  • IRCCS Ospedale San Raffaele, Milano
    Milan, Milano, Italy
    Not yet recruiting
  • Azienda Ospedaliero-Universitaria di Modena
    Modena, Modena, Italy
    Not yet recruiting
  • Bianalisi Carate Brianza, Monza e Brianza
    Monza, Monza, Italy
    Not yet recruiting
  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
    Novara, Novara, Italy
    Not yet recruiting
  • Azienda Ospedale Università Padova
    Padova, Padova, Italy
    Not yet recruiting
  • Azienda Ospedaliera Universitaria Policlinico 'Paolo Giaccone' di Palermo
    Palermo, Palermo, Italy
    Not yet recruiting
  • Azienda Sanitaria Friuli Occidentale, Ospedale di Pordenone
    Pordenone, Pordenone, Italy
    Not yet recruiting
  • Azienda Ospedaliera Universitaria Senese,
    Siena, Siena, Italy
    Not yet recruiting
  • Azienda Sanitaria Universitaria Giuliano Isontina
    Trieste, Trieste, Italy
    Not yet recruiting
  • Azienda Sanitaria Universitaria Friuli Centrale, Ospedale di Udine
    Udine, Udine, Italy
    Not yet recruiting
  • AULSS 3 Serenissima, Ospedale di Mestre
    Mestre, Venezia, Italy
    Not yet recruiting
  • Azienda Ospedaliera Universitaria Integrata di Verona
    Verona, Verona, Italy
    Not yet recruiting
  • AULSS 8 Berica, Ospedale S. Bortolo di Vicenza
    Vicenza, Vicenza, Italy
    Not yet recruiting
  • Ospedale di Desio, ASST Brianza
    Desio, Italy
    Not yet recruiting
  • ASL5 Spezzino, La Spezia
    La Spezia, Italy
    Not yet recruiting
  • ASST Grande Ospedale Metropolitano Niguarda, Milano
    Milan, Italy
    Not yet recruiting
  • Azienda ULSS 2 Marca Trevigiana
    Treviso, Italy
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.