ACRODAT Prospective Evaluation Study
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ClinicalTrials.gov Identifier: NCT04349839 |
Recruitment Status :
Recruiting
First Posted : April 16, 2020
Last Update Posted : April 16, 2020
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Condition or disease | Intervention/treatment |
---|---|
Acromegaly | Device: Acrodat software |
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Post-marketing Surveillance Study to Evaluate the Clinical Utility of ACRODAT in an International, Randomised, Non-interventional Study |
Estimated Study Start Date : | April 15, 2020 |
Estimated Primary Completion Date : | April 1, 2021 |
Estimated Study Completion Date : | March 2023 |

Group/Cohort | Intervention/treatment |
---|---|
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
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- 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).
- 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.
- 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)
- 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
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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
- 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.
- 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
- Medical therapy at baseline [ Time Frame: 2 years ]Proportion of patients receiving medical therapy at baseline (both groups)
- 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)
- 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
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349839
Contact: Jens Otto L Jørgensen, Professor | 78450000 ext 0045 | joj@clin.au.dk |
Denmark | |
Århus University Hospital | Recruiting |
Århus, Denmark, 8200 | |
Contact: Jens Otto L Jørgensen, Professor |
Responsible Party: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT04349839 |
Other Study ID Numbers: |
237269 |
First Posted: | April 16, 2020 Key Record Dates |
Last Update Posted: | April 16, 2020 |
Last Verified: | September 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Insulin-like growth factor-I (IGF-I) Growth hormone (GH) Disease control |
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases |