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

Acromegaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03158090
• Other study ID #: Titan
• Status: Recruiting
• Start date: December 15, 2017
• Est. completion date: January 30, 2051

Study information

• Verified date: March 2022
• Source: Ginkgo Leaf Center for Rare Disorders
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1965
• Est. completion date: January 30, 2051
• Est. primary completion date: December 30, 2050
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Be able and willing to sign the informed consent form (ICF)

2. Male, female, age 18-75 years old (including 18 years old and 75 years old).

3. Compliance with acromegaly diagnostic criteria:

• At least one laboratory or medical record shows that the patient is random GH = 2.5 µg / L
• At least one checklist or medical record shows radiographic evidence that the patient has a pituitary tumor

Exclusion Criteria:

1. Ectopic secretion of GH or pituitary cancer

2. The patient is diagnosed with other complicated malignancies, or has previously been diagnosed with another malignancy, and there is currently evidence of lesion residue.

3. Have a diagnosis of other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study.

4. Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study

Related Conditions & MeSH terms

• Acromegaly

Intervention

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

Locations

Country	Name	City	State
China	China Acromegaly Organization	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Ginkgo Leaf Center for Rare Disorders

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical outcome: overall survival	To compare overall survival of acromegaly in China between receiving surgery, drug and radiotherapeutics treatment	30 yeas
Secondary	clinical efficacy: control required GH level	To compare control required GH level of different treatment models (surgery, drug and radiotherapeutics treatment) in patients with acromegaly in China	30 years
Secondary	Cost-effectiveness	To compare cost for acromegaly of different treatment models (surgery, drug and radiotherapeutics treatment) in patients with acromegaly in China	30 years