AcromegalyNCT04349839
ACRODAT Prospective Evaluation Study
An observational study of Acromegaly, run by University of Aarhus at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- Acrodat software
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2020to 24 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Acromegaly
- Being tested
- Acrodat software
- Keywords
- Insulin-like growth factor-I (IGF-I), Growth hormone (GH), Disease control
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acrodat softwareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ACRODAT study arm | No intervention Receives: Device: Acrodat software | |
| Standard Practice Arm | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 2 years
Secondary outcomes (15)
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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 2 years
Medical therapy at baseline
Proportion of patients receiving medical therapy at baseline (both groups)
Measured: 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)
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start15 Jan 2020
- Primary completion1 Jan 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349839
- Sponsor's protocol ID
- 237269
- Status last verified
- Mar 2025
- First submitted
- 3 Apr 2020
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance Study to Evaluate the Clinical Utility of ACRODAT in an International, Randomised, Non-interventional Study
- ClinicalTrials.gov ID
- NCT04349839
- Acronym / sponsor ID
- 237269
- Conditions
- Acromegaly
- Keywords
- Insulin-like growth factor-I (IGF-I), Growth hormone (GH), Disease control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACRODAT study arm | – | Device: Acrodat softwareNo intervention |
| Standard Practice Arm | – | –No intervention |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acrodat softwareAcrodat 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. | Device | ACRODAT study arm |
Primary outcome
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).
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).
15 secondary outcomes
Change in ACRODAT® score
Time frame: 2 years
Disease activity divided in 3 categories
Time frame: 2 years
Change in disease activity category
Time frame: 2 years
IGF-I normalisation at any time defined by local lab
Time frame: 2 years
IGF-I normalisation throughout the study defined by local lab
Time frame: 2 years
IGF-I normalisation defined by local lab
Time frame: 2 years
IGF-I normalisation throughout the study defined by central lab
Time frame: 2 years
Achieving IGF-I normalisation after 24 months defined by central lab
Time frame: 2 years
Change in IGF-I levels defined by central lab
Time frame: 2 years
Disease activity on the 5 key parameters after 24 months
Time frame: 2 years
Disease activity on the 5 key parameters at all other time points then 24 months
Time frame: 2 years
Change in disease activity category after 24 months
Time frame: 2 years
Medical therapy at baseline
Time frame: 2 years
Change in medical therapy
Time frame: 2 years
Usability of the ACRODAT® tool
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in IGF-I levels (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.