Skip to main content
OpenTrials
Completed

NCT Number: NCT04349839

ACRODAT Prospective Evaluation 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Århus University Hospital

Aarhus, Århus, 8200, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with a confirmed diagnosis of acromegaly, aged 18 years or over, pre-treated and treatment naïve;
  • A follow-up visit is scheduled or anticipated for the patient at least once every year;
  • 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

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

Treatment and study plan

Acrodat software

Device

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.

Primary outcomes

  1. 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. 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).

Secondary outcomes

  1. 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. 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)

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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

  13. Medical therapy at baseline

    Time frame: 2 years

    Proportion of patients receiving medical therapy at baseline (both groups)

  14. 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)

  15. 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2020
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.