ACRODAT Prospective Evaluation Study

University of Aarhus500 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Acromegaly

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

Århus University Hospital

Aarhus, Århus, Denmark

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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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

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