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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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

Brief 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 Summary:

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.


Sponsor: Ginkgo Leaf Center for Rare Disorders

Current Primary Outcome: clinical outcome: overall survival [ Time Frame: 30 yeas ]

To compare overall survival of acromegaly in China between receiving surgery, drug and radiotherapeutics treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • clinical efficacy: control required GH level [ Time Frame: 30 years ]
    To compare control required GH level of different treatment models (surgery, drug and radiotherapeutics treatment) in patients with acromegaly in China
  • Cost-effectiveness [ Time Frame: 30 years ]
    To compare cost for acromegaly of different treatment models (surgery, drug and radiotherapeutics treatment) in patients with acromegaly in China


Original Secondary Outcome: Same as current

Information By: Ginkgo Leaf Center for Rare Disorders

Dates:
Date Received: May 6, 2017
Date Started: August 30, 2017
Date Completion: January 30, 2051
Last Updated: May 22, 2017
Last Verified: May 2017