NCT03158090

The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,965 (estimated)
• Sponsor: Ginkgo Leaf Center for Rare Disorders · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

This study is a prospective, noninteractive, observational, and longitudinal study aimed at assessing the treatment pattern and clinical outcome of acromegaly in China.

Detailed description

The study was designed to answer some of the most important questions about the treatment modalities of acromegaly, the relevance of these treatment modalities to patients' clinical outcomes and the economic impact of treatment programs on patients. These answers may be of great help to the treatment of these populations and may also help to make treatment and related health decisions in the future. This study only collects the patient's medical information during the study and does not interfere with the patient's treatment. Each patient will be assigned a unique patient identification number for the study. The sites will maintain a confidential decode list that enables the study staff at the site to link the assigned patient identification number with the patient's medical records for extraction of study-required data. These registries will be maintained following International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) and the respective local privacy laws and requirements.

Conditions

• Acromegaly

Interventions

Type	Name	Description
PROCEDURE	Transnasal butterfly surgery	The patient will be treated in accordance with the advice of the local doctor in charge, and this study does not interfere with any treatment of the patient.
DRUG	sandostatin	The patient will be treated in accordance with the advice of the local doctor in charge, and this study does not interfere with any treatment of the patient
RADIATION	radiotherapy	The patient will be treated in accordance with the advice of the local doctor in charge, and this study does not interfere with any treatment of the patient

Timeline

• Start date: 2017-12-15
• Primary completion: 2050-12-30
• Completion: 2051-01-30
• First posted: 2017-05-17
• Last updated: 2022-03-16

Locations

1 site across 1 country: China