Predictive Factors Study

Non-interventional, Observational, Long Term Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel (ATG) Treatment in Patients With Acromegaly.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02020499

Acronym

TAPAS

Enrollment

Registered

2013-12-25

Start date

2014-08-31

Completion date

2015-09-30

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Brief summary

This is a long term study to evaluate common therapeutic algorithms and possible predictive parameters for Somatuline Autogel treatment in patients with Acromegaly.

Interventions

DRUGSomatuline Autogel® (lanreotide) 60, 90, 120 mg.

Patients receiving treatment as prescribed by the investigator and according to current treatment recommendations and routine clinical practice, and in line with local regulations.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of Acromegaly. * Males and females aged 18 years and older. * Signed informed consent (patient must give consent to the collection of retrospective data). * Patients who have had surgery may enter the study 3 months post-surgery and evaluated for the duration of the study. * With the intention to be treated with ATG (decision to prescribe ATG made prior to inclusion into the study) or already being treated with ATG. * If already being treated with ATG: Previous ATG treatment maximum of 3 months. AND Minimum data available (demographic data, disease history including previous treatments, GH, IGF-1 levels at baseline and under treatment as applicable). * Not receiving Dopamine Agonists or other medical therapy (Pegvisomant, or other somatostatin analogues) for the treatment or symptom control of acromegaly.

Exclusion criteria

* The subject has had radiotherapy in the last 5 years. * The subject has had surgery in the last 3 months. * The subject has already been included in this study. * Participation in an interventional trial, or receiving experimental drug.

Design outcomes

Primary

Measure	Time frame
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline	Baseline and 4 weeks

Secondary

Measure	Time frame
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline	Baseline, 1 year and 3 years

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026