ACRODAT Prospective Evaluation Study

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Brief Title

ACRODAT Prospective Evaluation Study

Official Title

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

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 Type

Observational


Primary Outcome

Changes in IGF-I levels

Secondary Outcome

 Change in ACRODAT® score

Condition

Acromegaly

Intervention

Acrodat software

Study Arms / Comparison Groups

 ACRODAT study arm
Description:  No intervention

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

500

Start Date

April 15, 2020

Completion Date

March 2023

Primary Completion Date

April 1, 2021

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.
      

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

, 78450000, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT04349839

Organization ID

237269


Responsible Party

Sponsor

Study Sponsor

University of Aarhus


Study Sponsor

, , 


Verification Date

September 2019