NCT04349839

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

3.7 years

First QC Date

April 3, 2020

Last Update Submit

November 28, 2023

Conditions

Acromegaly

Keywords

Insulin-like growth factor-I (IGF-I)Growth hormone (GH)Disease control

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (15)

  • Change in ACRODAT® score

    2 years

  • Disease activity divided in 3 categories

    2 years

  • Change in disease activity category

    2 years

  • IGF-I normalisation at any time defined by local lab

    2 years

  • IGF-I normalisation throughout the study defined by local lab

    2 years

  • +10 more secondary outcomes

Study Arms (2)

ACRODAT study arm

No intervention

Device: Acrodat software

Standard Practice Arm

No intervention

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.

ACRODAT study arm

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Århus University Hospital

Aarhus, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 16, 2020

Study Start

January 15, 2020

Primary Completion

October 1, 2023

Study Completion

February 1, 2025

Last Updated

December 4, 2023

Record last verified: 2023-11

Locations

DK(1)