Clinical trial NCT04349839: ACRODAT Prospective Evaluation Study
Official title: Post-marketing Surveillance Study to Evaluate the Clinical Utility of ACRODAT in an International, Randomised, Non-interventional Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acromegaly
Keywords: Insulin-like growth factor-I (IGF-I)
Growth hormone (GH)
Disease control
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Eligibility 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.

Primary outcomes:
measure: Changes in IGF-I levels
timeFrame: 2 years
measure: Overall disease activity score using ACRODAT®
timeFrame: 2 years
Secondary outcomes:
measure: Change in ACRODAT® score
timeFrame: 2 years
measure: Disease activity divided in 3 categories
timeFrame: 2 years
measure: Change in disease activity category
timeFrame: 2 years
measure: IGF-I normalisation at any time defined by local lab
timeFrame: 2 years
measure: IGF-I normalisation throughout the study defined by local lab
timeFrame: 2 years
measure: IGF-I normalisation defined by local lab
timeFrame: 2 years
measure: IGF-I normalisation throughout the study defined by central lab
timeFrame: 2 years
measure: Achieving IGF-I normalisation after 24 months defined by central lab
timeFrame: 2 years
measure: Change in IGF-I levels defined by central lab
timeFrame: 2 years
measure: Disease activity on the 5 key parameters after 24 months
timeFrame: 2 years
measure: Disease activity on the 5 key parameters at all other time points then 24 months
timeFrame: 2 years
measure: Change in disease activity category after 24 months
timeFrame: 2 years
measure: Medical therapy at baseline
timeFrame: 2 years
measure: Change in medical therapy
timeFrame: 2 years
measure: Usability of the ACRODAT® tool
timeFrame: 2 years
Other outcomes:
Locations:
city: Århus
country: Denmark
facility: Århus University Hospital
Study officials:
References: