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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical treatment | The subject was received transnasal butterfly surgery. |
| |
| Drug therapy | The subject was received drug treatment including somatostatin analogues such as sandostatin and lanreotide, dopamine receptor agonists and GH receptor antagonists. |
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| Radiotherapeutics | he subject was received radiotherapy methods including radiotherapy, linear accelerator X knife, gamma knife and so on. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transnasal butterfly surgery | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical outcome: overall survival | To compare overall survival of acromegaly in China between receiving surgery, drug and radiotherapeutics treatment | 30 yeas |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cost-effectiveness |
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Inclusion Criteria:
Be able and willing to sign the informed consent form (ICF)
Male, female, age 18-75 years old (including 18 years old and 75 years old).
Compliance with acromegaly diagnostic criteria:
Exclusion Criteria:
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Chinese adult acromegaly patients are invited to participate in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Acromegaly Organization | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| C060347 | lanreotide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| sandostatin | 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 |
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| radiotherapy | 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 |
|
To compare cost for acromegaly of different treatment models (surgery, drug and radiotherapeutics treatment) in patients with acromegaly in China
| 30 years |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D013812 | Therapeutics |