NCT07433777 Reference Intervals With Indirect Methods in Italy
| NCT ID | NCT07433777 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro di Riferimento Oncologico - Aviano |
| Condition | Reference Intervals |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000,000 participants |
| Start Date | 2025-10-08 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000,000 participants in total. It began in 2025-10-08 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Reference intervals are an essential tool for the clinical interpretation of laboratory test results. Traditionally, these interval are determined using samples from healthy individuals, a process that is resource-intensive, time-consuming, and require the active recruitment of healthy volunteers. In recent years, due to the increasing availability of electronic health record (EHR) databases and the growing number of laboratory tests, it is possible to determine the reference intervals indirectly. This approach relies on the analysis of routine data acquired in clinical laboratories, eliminating the need for active recruiting healthy subjects and significantly reducing costs. Moreover, the method has the potential to eliminate the selection bias of an ultra-healthy population typical of the direct methods. The indirect methods for determining reference intervals have evolved from simple strategies of isolating the healthy population using sample metadata, to sophisticated statistical models that effectively distinguish normal from pathological distributions. One of the advanced techniques, RefineR, has reached an excellent combination of accuracy, robustness, and computational efficiency, outperforming previous methods. It has been implemented as an open-source R package, facilitating its application in real-world settings. In recognition of these advantages, the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine), through its Committee on Reference Intervals and Decision Limits (C-RIDL), has promoted the adoption of indirect methods for determining reference intervals, highlighting the advantages of this strategy, including greater speed, lower costs, and the absence of a need to recruit healthy donors. Furthermore, a recent study has highlighted age-related physiological variations in hemoglobin levels in elderly population. This underscores the need for defining age-specific reference intervals which are currently absent from most laboratory reports, potentially impacting diagnostic accuracy.
Eligibility Criteria
Inclusion Criteria: * no one Exclusion Criteria: * no one
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07433777 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 100 Years, studying Reference Intervals. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07433777 currently recruiting?
Yes, NCT07433777 is actively recruiting participants. Contact the research team at fabio.delben@cro.it for enrollment information.
Where is the NCT07433777 trial being conducted?
This trial is being conducted at Altamura, Italy, Ancona, Italy, Arezzo, Italy, Belluno, Italy and 11 additional locations.
Who is sponsoring the NCT07433777 clinical trial?
NCT07433777 is sponsored by Centro di Riferimento Oncologico - Aviano. The trial plans to enroll 1,000,000 participants.
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