Reference ranges from routine lab data in Italy
Reference Intervals With Indirect Methods in Italy
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 |
|---|---|
| Enrollment | 1000000 (estimated) |
| Ages | 0 Years to 100 Years |
| Sex | All |
| Sponsor | Centro di Riferimento Oncologico - Aviano Academic / other |
| Locations | 24 sites (Altamura, Altamura and 23 other locations) |
| Trial ID | NCT07433777 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: The project uses routine lab results from patients whose tests were performed at participating Italian hospitals and laboratories.
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.
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 performed: Indirect methods have been applied in other countries and shown promising results for many analytes, though performance varies by test and population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * no one Exclusion Criteria: * no one
Where this trial is running
Altamura, Altamura and 23 other locations
- 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)
- 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)
- Centro di Riferimento Oncolgico -IRCCS — Aviano, Pordenone, Italy (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.