ACRODAT Prospective Evaluation Study

• ClinicalTrials.gov Identifier: NCT04349839
• Recruitment Status: Recruiting
• First Posted: April 16, 2020
• Last Update Posted: April 16, 2020
• Sponsor: University of Aarhus
• Information provided by (Responsible Party): University of Aarhus

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment
Acromegaly	Device: Acrodat software

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

• 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

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Biospecimen Retention:   Samples With DNA

Serum samples

Eligibility Criteria

• 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

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.

Criteria

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.

Contacts and Locations

Contacts

Contact: Jens Otto L Jørgensen, Professor; 78450000 ext 0045; joj@clin.au.dk

Locations

Denmark

Århus University Hospital; Recruiting

Århus, Denmark, 8200

Contact: Jens Otto L Jørgensen, Professor

Sponsors and Collaborators

University of Aarhus

More Information

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT04349839
• Other Study ID Numbers: 237269
• First Posted: April 16, 2020
• 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

Keywords provided by University of Aarhus:

Insulin-like growth factor-I (IGF-I); Growth hormone (GH); Disease control

Additional relevant MeSH terms:

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