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.
Status
Recruiting
Phase
Not applicable
Enrollment
1,965
Locations
1
Results
Not posted
Publications
0
Study summary
This study is a prospective, noninteractive, observational, and longitudinal study aimed at assessing the treatment pattern and clinical outcome of acromegaly in China.
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.
Interventions
PROCEDURE
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
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
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
First posted
May 17, 2017
Study start
Dec 15, 2017
Primary completion
Dec 30, 2050
Study completion
Jan 30, 2051
Results posted
Not reported
Registry updated
Mar 16, 2022
Outcomes
clinical outcome: overall survival
Time frame · 30 yeas
To compare overall survival of acromegaly in China between receiving surgery, drug and radiotherapeutics treatment
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
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
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
China Acromegaly Organization
Guangzhou, Guangdong, China
Publications
No PMID-linked publications were present in this registry snapshot.
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