ACRODAT Prospective Evaluation Study

June 8, 2026 updated by: University of Aarhus

Post-marketing Surveillance Study to Evaluate the Clinical Utility of ACRODAT in an International, Randomised, Non-interventional Study

ACRODAT® is a new software medical device developed by a group of acromegaly experts to help practising endocrinologists assess disease activity in patients with acromegaly. It uses 5 key parameters (IGF-I level, tumour status, comorbidities, symptoms and Quality of life) to evaluate the patient's health status. The purpose of this post marketing surveillance study is to prospectively evaluate whether patients monitored by ACRODAT® with appropriate clinical decisions based on disease activity status will benefit from improved treatment outcomes both in the short and in the long term.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

This is an international, multicentre, randomised, non-interventional, collaborative post marketing surveillance study to assess the clinical use of the newly developed software medical device named ACRODAT®. Patients newly enrolled will be followed-up over a 2 year period. Patients will be assigned to the ACRODAT® group or the Standard Practice group according to a central randomisation. Patients assigned to the ACRODAT® arm will be followed up with the treating physician using ACRODAT® at every visit. The frequency of visits will be according to standard practice in the clinic. Patients not followed up with ACRODAT® will be followed-up in accordance with the standard medical practice of the hospital where they have been recruited, until study completion (Standard Practice arm).

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.
Observational

Enrollment (Actual)

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.
500

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.
  • Name: Jens Otto L Jørgensen, Professor
  • Phone Number: 0045 78450000
  • Email: joj@clin.au.dk

Study Locations

  • Denmark
    • Århus
      • Aarhus, Århus, Denmark, 8200
        • Århus University Hospital

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The post marketing surveillance study population will be patients with acromegaly in specialist care clinics and hospital clinics. The results from the validation study which guided development of ACRODAT® was conducted with hypothetical patient cases which were generally described as "an adult patient with a confirmed diagnosis of acromegaly, who is presenting with the following…". Therefore, ACRODAT® may be used for all adult patients with confirmed diagnosis of acromegaly or being followed up for acromegaly.

Description

Inclusion Criteria:

  1. All patients with a confirmed diagnosis of acromegaly, aged 18 years or over, pre-treated and treatment naïve;
  2. A follow-up visit is scheduled or anticipated for the patient at least once every year;
  3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of and consented to all pertinent aspects of the study.

Exclusion Criteria:

  1. Patients who are surgically cured and remain controlled for at least 3 years;
  2. Patients who are unable to understand the nature of the study and/or unwilling to sign an informed consent;
  3. Patients who are unwilling to abide by the guidelines of the study;
  4. Patients participating in any clinical trial on an investigational medicine or software medical device/evaluation tool for acromegaly.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
ACRODAT study arm
No intervention
Device: Acrodat software
Acrodat is a newly developed software medical device to access disease activity in acromegaly based on five parameters: IGF-I, tumour size, comorbidities, symptoms and quality of life.
Standard Practice Arm
No intervention

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
Changes in IGF-I levels
Time Frame: 2 years
Change from baseline in IGF-I value after 24 months of patient management based on the local lab IGF-I values ( ACRODAT® vs. standard care).
2 years
Overall disease activity score using ACRODAT®
Time Frame: 2 years
Final Overall disease activity score (0-100) as measured with ACRODAT® after 24 months of patient management (ACRODAT® vs. standard care).
2 years

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
Change in ACRODAT® score
Time Frame: 2 years
Change from baseline in Overall Disease Activity Score as measured with ACRODAT® for patients in the ACRODAT® group after 24 months.
2 years
Disease activity divided in 3 categories
Time Frame: 2 years
Proportion of patients in each Overall Disease Activity Category (Stable, mild Disease Activity, Significant Disease Activity) after 24 months of patient management (both groups)
2 years
Change in disease activity category
Time Frame: 2 years
Change in proportions in each Overall Disease Activity Category between baseline and after 24 months of patient management in the ACRODAT® group
2 years
IGF-I normalisation at any time defined by local lab
Time Frame: 2 years
Proportion of patients in each group achieving IGF-I normalisation at any time (post-baseline) during the course of the study, where IGF-I normalisation is defined as an (age adjusted) IGF-I value within the normal range defined by the local lab. This proportion will also be presented split by controlled status at baseline.
2 years
IGF-I normalisation throughout the study defined by local lab
Time Frame: 2 years
Proportion of patients in each group who maintain IGF-I normalisation throughout the study, where IGF-I normalisation is defined as an IGF-I value within the normal range defined by the local lab.
2 years
IGF-I normalisation defined by local lab
Time Frame: 2 years
Proportion of patients in each group achieving IGF-I normalisation at Month 24 where IGF-I normalisation is defined as an IGF-I value within the normal range defined by the local lab. This proportion will also be presented split by controlled status at baseline.
2 years
IGF-I normalisation throughout the study defined by central lab
Time Frame: 2 years
Proportion of patients in each group who were 'controlled' at baseline and who maintain IGF-I normalisation throughout the study, where IGF-I normalisation is defined as an age adjusted IGF-I value within the normal range defined by the central lab. (Presented by baseline controlled status as defined by the investigator, and also by the controlled status according to the central IGF-1 lab values within the normal range).
2 years
Achieving IGF-I normalisation after 24 months defined by central lab
Time Frame: 2 years
Proportion of patients in each group achieving IGF-I normalisation at Month 24 where IGF-I normalisation is defined as an age adjusted IGF-I value within the normal range defined by the central lab. This proportion will also be presented split by controlled status at baseline as defined by the baseline status by the investigator and also by the controlled status according to the central IGF-1 lab values within the normal range.
2 years
Change in IGF-I levels defined by central lab
Time Frame: 2 years
Change from baseline in IGF-I defined by the central lab after 24 months of patient management. Comparison between both groups.
2 years
Disease activity on the 5 key parameters after 24 months
Time Frame: 2 years
Proportion of patients with individual parameter (tumour status, IGF-I, comorbidities, symptoms, ACROQoL) ACRODAT® scores categorised as 1=Stable, 2=Mild Disease Activity, 3=Significant Disease Activity after 24 months of patient management as defined in the ACRODAT tool. Comparison between both groups
2 years
Disease activity on the 5 key parameters at all other time points then 24 months
Time Frame: 2 years
Proportion of patients with individual parameter (tumour status, IGF-I, comorbidities, symptoms, ACROQoL) ACRODAT® scores categorised as 1=Stable, 2=Mild Disease Activity, 3=Significant Disease Activity at all other available time points (Month 12 at a minimum) as defined in the ACRODAT tool. For the ACRODAT® group only.
2 years
Change in disease activity category after 24 months
Time Frame: 2 years
Change in proportions in each individual parameter score (i.e. 1=Stable, 2=Mild Disease Activity, 3=Significant Disease Activity) between baseline and after 24 months of patient management in the ACRODAT® group
2 years
Medical therapy at baseline
Time Frame: 2 years
Proportion of patients receiving medical therapy at baseline (both groups)
2 years
Change in medical therapy
Time Frame: 2 years
Proportion of patients receiving a change in medical therapy and/or change in dose at any time during the study (both groups)
2 years
Usability of the ACRODAT® tool
Time Frame: 2 years
Usability of the ACRODAT® tool according to the treating physician/nurse and patient (data collected via PRAC-Test) for the ACRODAT group
2 years

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.
University of Aarhus

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 (Actual)

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.
January 15, 2020

Primary Completion (Actual)

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.
January 1, 2025

Study Completion (Actual)

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.
March 24, 2025

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).
April 3, 2020

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.
April 14, 2020

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.
April 16, 2020

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.
June 11, 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.
June 8, 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.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 237269

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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