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 type | Observational |
|---|---|
| Ages | 0 Years to 100 Years |
| Sex | All |
| Enrollment | 1000000 (estimated) |
| Sponsor | Centro di Riferimento Oncologico - Aviano Academic / other |
| Locations | 24 sites (Altamura, Altamura and 23 other locations) |
| Status | Recruiting |
| Started | October 8, 2025 |
| Main results expected | June 1, 2028 |
| Study ends | June 1, 2028 |
| Registry record updated | February 25, 2026 |
| Trial ID | NCT07433777 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
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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
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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
- Study coordinator: Fabio Del Ben
- Email: fabio.delben@cro.it
- Phone: 0434659101
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.