Post-marketing Surveillance Study to Evaluate the Clinical Utility of ACRODAT in an International, Randomised, Non-interventional Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Changes in IGF-I levels
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Change in disease activity category after 24 months(2 years)
- Usability of the ACRODAT® tool(2 years)
- Change in ACRODAT® score(2 years)
- Disease activity divided in 3 categories(2 years)
- Change in IGF-I levels defined by central lab(2 years)
- Change in disease activity category(2 years)
- IGF-I normalisation at any time defined by local lab(2 years)
- IGF-I normalisation defined by local lab(2 years)
- IGF-I normalisation throughout the study defined by central lab(2 years)
- Disease activity on the 5 key parameters after 24 months(2 years)
- Disease activity on the 5 key parameters at all other time points then 24 months(2 years)
- Change in medical therapy(2 years)
- IGF-I normalisation throughout the study defined by local lab(2 years)
- Achieving IGF-I normalisation after 24 months defined by central lab(2 years)
- Medical therapy at baseline(2 years)