ACRODAT Prospective Evaluation Study

Acromegaly Clinical Trial

Official title:

Post-marketing Surveillance Study to Evaluate the Clinical Utility of ACRODAT in an International, Randomised, Non-interventional Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04349839
• Other study ID #: 237269
• Status: Active, not recruiting
• Start date: January 15, 2020
• Est. completion date: February 1, 2025

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: February 1, 2025
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acromegaly

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.

Locations

Country	Name	City	State
Denmark	Århus University Hospital	Århus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2 years
Primary	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).	2 years
Secondary	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.	2 years
Secondary	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)	2 years
Secondary	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	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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).	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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	2 years
Secondary	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.	2 years
Secondary	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	2 years
Secondary	Medical therapy at baseline	Proportion of patients receiving medical therapy at baseline (both groups)	2 years
Secondary	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)	2 years
Secondary	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	2 years