An observational study in Acromegaly, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by University of Aarhus · Observational
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.
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).
202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.
This study's enrollment of 500 is above the median of 100 across 81 observational studies indexed under Acromegaly.
Browse Acromegaly studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention
Device: Acrodat software
No intervention
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.
Changes in IGF-I levels
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).
Time frame: 2 years
Overall disease activity score using ACRODAT®
Final Overall disease activity score (0-100) as measured with ACRODAT® after 24 months of patient management (ACRODAT® vs. standard care).
Time frame: 2 years
Change in ACRODAT® score
Change from baseline in Overall Disease Activity Score as measured with ACRODAT® for patients in the ACRODAT® group after 24 months.
Time frame: 2 years
Disease activity divided in 3 categories
Proportion of patients in each Overall Disease Activity Category (Stable, mild Disease Activity, Significant Disease Activity) after 24 months of patient management (both groups)
Time frame: 2 years
Change in disease activity category
Change in proportions in each Overall Disease Activity Category between baseline and after 24 months of patient management in the ACRODAT® group
Time frame: 2 years
IGF-I normalisation at any time defined by local lab
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.
Time frame: 2 years
IGF-I normalisation throughout the study defined by local lab
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.
Time frame: 2 years
IGF-I normalisation defined by local lab
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.
Time frame: 2 years
IGF-I normalisation throughout the study defined by central lab
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).
Time frame: 2 years
Achieving IGF-I normalisation after 24 months defined by central lab
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.
Time frame: 2 years
Change in IGF-I levels defined by central lab
Change from baseline in IGF-I defined by the central lab after 24 months of patient management. Comparison between both groups.
Time frame: 2 years
Disease activity on the 5 key parameters after 24 months
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
Time frame: 2 years
Disease activity on the 5 key parameters at all other time points then 24 months
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.
Time frame: 2 years
Change in disease activity category after 24 months
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
Time frame: 2 years
Medical therapy at baseline
Proportion of patients receiving medical therapy at baseline (both groups)
Time frame: 2 years
Change in medical therapy
Proportion of patients receiving a change in medical therapy and/or change in dose at any time during the study (both groups)
Time frame: 2 years
Usability of the ACRODAT® tool
Usability of the ACRODAT® tool according to the treating physician/nurse and patient (data collected via PRAC-Test) for the ACRODAT group
Time frame: 2 years
Ran from Jan 2020 to primary completion in Jan 2025, 59 months.
Of 26 observational studies under Acromegaly, half reached primary completion within 85 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 263. This study's 59 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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