Clinical Validation of an Artificial Intelligence System for the Interpretation of Laboratory Test Results Combined With a Structured Medical History (LTC-VALID)

September 3, 2026 updated by: Labplus Sp. z o.o.

Telemedicine Technology Supporting the Diagnostic Process Based on Automated Analysis of Laboratory Test Results With a Structured Medical History: A Prospective, Two-Center, Two-Phase Clinical Validation Study

This study evaluates a certified artificial intelligence (AI) based software system that automatically interprets laboratory test results in combination with a structured, dynamically generated medical history questionnaire.

The purpose of the study is to determine how accurately and how safely the system assigns a patient to a category of urgency of medical contact, and how closely the interpretations produced by the system correspond to the assessment of an expert physician.

Adults treated at two university hospitals in Katowice, Poland, who are referred for laboratory testing, complete an electronic medical history questionnaire after their laboratory results become available. The system then generates an interpretation for each laboratory result, including a category of urgency of medical contact, a suggested medical specialty and suggested further laboratory tests. The attending physician independently records a clinical assessment of the same laboratory results and medical history without access to the output of the system. An independent expert physician subsequently establishes the reference assessment, blinded to the authorship of the assessments being compared. The interpretation report is released to the participant only after the assessment of the attending physician has been recorded and locked.

The study is conducted in two phases. The first phase (609 participants) is exploratory and uses the initial version of the system. The second phase (290 participants) is confirmatory and uses the final, frozen version of the system. All outcome measures are assessed in both phases; the pre-specified confirmatory hypothesis test applies to the second phase.

The endpoints of this study are properties of the software system, namely the concordance of its output with an expert reference assessment. Health outcomes of participants are not measured.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Design. LTC-VALID is a prospective, two-center, single-arm, two-phase clinical validation study of a CE-marked class IIa medical device software intended for the automated interpretation of laboratory test results.

Phase structure. Phase I (609 participants, months 1 to 9) is exploratory and serves algorithm development and gap identification using version 1.0 of the software. An interposed optimization stage (months 9 to 10) produces a frozen version 2.0. Phase II (290 participants, months 11 to 13) is confirmatory. All outcome measures listed below are collected identically in both phases and are reported separately by phase. Results from the two phases are not pooled, because the two phases evaluate different versions of the software. The pre-specified confirmatory hypothesis test for the co-primary measures is applied to Phase II data; Phase I results for the same measures are exploratory and are reported descriptively.

Procedures. Eligible participants provide written informed consent, are referred for a mandatory basic laboratory panel and one or two of 29 specialist laboratory panels, and provide a single blood draw at a certified laboratory collection point. After the results become available, the participant completes a dynamically generated electronic medical history questionnaire. The software produces one interpretation per laboratory result; interpretations are not aggregated by the software. The attending physician records an independent clinical assessment of the same data while blinded to the software output; this assessment is locked before the interpretation report is released to the participant. Participants complete a questionnaire evaluating the report, and physicians complete a form evaluating the completeness and relevance of the automated medical history.

Reference standard and comparators. An independent expert physician receives the complete documentation and establishes an own reference assessment before reviewing the assessments to be compared. The assessments of the software, of the attending physician and of large language models are presented in random order and blinded as to authorship. The comparators are comparators of assessment, not study arms; the study is single-arm and no randomization or control group is used.

Reporting standard. The primary analysis follows the Standards for Reporting of Diagnostic Accuracy Studies (STARD). The study is a diagnostic accuracy study and not a study of clinical effectiveness.

Statistical approach. The two primary outcome measures are co-primary and are evaluated using an intersection-union test; both must meet their pre-specified criteria. The pre-specified criteria apply to Phase II: for the safety measure, the lower bound of the one-sided 95 percent confidence interval is at or above 95 percent; for the accuracy measure, at or above 90 percent. Confidence intervals for proportions are calculated using exact methods (Clopper-Pearson). Phase I is exploratory and its data are reported descriptively. Sensitivity for the rare urgency categories is reported with confidence intervals and event counts as a secondary, non-confirmatory measure, because its denominator is not sufficient for formal hypothesis testing at the planned sample size.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
899

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
      • Katowice, Poland
        • Independent Public Clinical Hospital named after Andrzej Mielecki, Medical University of Silesia
        • Contact:
      • Katowice, Poland
        • Prof. K. Gibinski University Clinical Center, Medical University of Silesia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Treated at one of the two participating clinical centers of the Medical University of Silesia
  • Age 18 years or older and under 80 years
  • Presence of symptoms justifying the initiation of a diagnostic work-up
  • Meets the criteria for ordering at least one of the 29 specialist laboratory panels included in the study
  • Able to complete an electronic questionnaire in Polish independently, using a smartphone or a personal computer
  • Holds a Polish national identification number (PESEL)
  • Written informed consent covering all three components of the study

Exclusion Criteria:

  • Pregnancy
  • Age 80 years or older
  • Inability to provide informed consent, including cognitive impairment or a language barrier
  • Participation in another clinical study that could affect the results
  • Refusal of consent to any of the three components of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AI-Based Interpretation of Laboratory Test Results
Single arm. All participants complete an electronic, dynamically generated medical history questionnaire administered by the software after their laboratory results become available, and subsequently receive a software-generated interpretation report. The report is released to the participant only after the independent clinical assessment of the attending physician has been recorded and locked. No control group is used. The assessments of the attending physician, of an independent expert physician and of large language models are comparators of assessment and do not constitute study arms.
Diagnostic test: AI-based laboratory result interpretation software
A CE-marked class IIa medical device software for the automated interpretation of laboratory test results, operated within its intended purpose. The software administers a structured medical history questionnaire in which subsequent questions are selected dynamically on the basis of the laboratory results and of previous answers. For each laboratory result the software generates one interpretation, comprising a category of urgency of medical contact (immediate, urgent, routine, or no need for medical contact), a suggested medical specialty, a list of suggested further laboratory tests, and an explanatory text addressed to the patient. Interpretations are not aggregated by the software. The interpretation report is generated once per participant, after completion of the questionnaire, and is released to the participant after the assessment of the attending physician has been recorded and locked. The generated report is not used to direct the clinical management of the participant.
Other Names:
  • LabTest Checker

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants for Whom the Urgency Category Assigned by the Software Was Not Lower Than the Category Assigned by the Expert Physician (Patient Triage Safety Indicator)
Time Frame: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
The urgency category assigned by the software is compared with the urgency category assigned by an expert physician serving as the reference standard. The urgency categories, ordered from highest to lowest, are: immediate medical contact, urgent medical contact, routine medical contact, and no need for medical contact. A participant is counted in the numerator when the category assigned by the software is the same as or higher than the category assigned by the expert physician. The measure is the percentage of participants counted in the numerator. Range: 0 to 100 percent; higher values indicate better performance. The measure is assessed separately in each study phase and data from the two phases are not combined. Each comparison is based on data locked at the time of enrollment; the expert assessment is performed retrospectively, in batches, on a locked dataset, and the calendar timing of the batch review does not affect the measured quantity.
Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Percentage of Participants for Whom the Urgency Category Assigned by the Software Was Identical to the Category Assigned by the Expert Physician (Patient Triage Accuracy)
Time Frame: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
The urgency category assigned by the software is compared with the urgency category assigned by an expert physician serving as the reference standard. The urgency categories, ordered from highest to lowest, are: immediate medical contact, urgent medical contact, routine medical contact, and no need for medical contact. A participant is counted in the numerator when the category assigned by the software is identical to the category assigned by the expert physician. The measure is the percentage of participants counted in the numerator. Range: 0 to 100 percent; higher values indicate better performance. The measure is assessed separately in each study phase and data from the two phases are not combined. Each comparison is based on data locked at the time of enrollment; the expert assessment is performed retrospectively, in batches, on a locked dataset, and the calendar timing of the batch review does not affect the measured quantity.
Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensitivity for the Immediate Medical Contact Category
Time Frame: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Proportion of participants assigned by the expert physician to the immediate medical contact category who were assigned to the same category by the software. Range: 0 to 100 percent; higher values indicate better performance. Reported with a 95 percent confidence interval and the number of events. No formal hypothesis test is performed, because the expected denominator at the planned sample size is not sufficient for confirmatory testing. Assessed separately in both study phases.
Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Sensitivity for the Urgent Medical Contact Category
Time Frame: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Proportion of participants assigned by the expert physician to the urgent medical contact category who were assigned to the same category by the software. Range: 0 to 100 percent; higher values indicate better performance. Reported with a 95 percent confidence interval and the number of events. No formal hypothesis test is performed, because the expected denominator at the planned sample size is not sufficient for confirmatory testing. Assessed separately in both study phases.
Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Agreement on Urgency Category Measured by Quadratic Weighted Cohen's Kappa
Time Frame: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Agreement between the urgency category assigned by the software and by the expert physician, expressed as Cohen's kappa with quadratic weights applied to the four ordered urgency categories. Range: -1 to 1; higher values indicate better agreement. Reported with a 95 percent confidence interval. Supplementary to the co-primary measure of accuracy. Assessed separately in both study phases.
Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Per-Result Concordance on Recommended Medical Specialty
Time Frame: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Concordance between the medical specialty recommended by the software and by the expert physician, evaluated at the level of a single laboratory result. Reported as precision and macro-averaged recall. Range: 0 to 1; higher values indicate better performance. Assessed separately in both study phases.
Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Per-Result Concordance on Recommended Additional Laboratory Tests
Time Frame: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Concordance between the additional laboratory tests recommended by the software and by the expert physician, evaluated at the level of a single laboratory result. Reported as precision and macro-averaged recall. Range: 0 to 1; higher values indicate better performance. Assessed separately in both study phases.
Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Comparative Concordance of the Software, the Attending Physician and Large Language Models Against the Reference Standard
Time Frame: Months 15 to 18 after study start
Concordance of three sources of assessment - the software, the attending physician and large language models - with the same expert reference assessment, using the measures defined above. Assessments are compared retrospectively on a locked dataset. Reported descriptively for each source; no ranking test is performed.
Months 15 to 18 after study start
Proportion of Participants Rating the Interpretation Report as Comprehensible
Time Frame: Immediately after release of the report
Proportion of participants who, in a study-specific questionnaire completed after release of the interpretation report, indicate that the content of the report was comprehensible. Range: 0 to 100 percent; higher values indicate better performance. Assessed separately in both study phases.
Immediately after release of the report
Proportion of Automated Medical History Records Assessed by the Attending Physician as Complete and Relevant
Time Frame: Immediately after the assessment of the attending physician
Proportion of automated medical history records for which the attending physician reports no objections regarding completeness or relevance, recorded in a study-specific form. Range: 0 to 100 percent; higher values indicate better performance. Assessed separately in both study phases.
Immediately after the assessment of the attending physician

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Labplus Sp. z o.o.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of Silesia in Katowice

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jerzy Chudek, MD, PhD, Medical University of Silesia in Katowice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LP004
  • FEDS.01.02-IP.01-0078/24 (Other Grant/Funding Number: European Funds for Lower Silesia 2021-2027 (FEDS))
  • BNW/NWN/0052/KB1/34/26 (Other Identifier: Bioethics Committee, Medical University of Silesia in Katowice)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared. The study protocol and the statistical analysis plan may be made available with the primary publication. Individual-level data are subject to trade secret protection and are not covered by the scope of participant consent for redistribution.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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