The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transnasal butterfly surgery, sandostatin, radiotherapy.
- Who it may be relevant to
- Registry conditions: Acromegaly. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- clinical outcome: overall survival [Time frame: 30 yeas]
Secondary outcome measures (2)
- clinical efficacy: control required GH level [Time frame: 30 years]
- Cost-effectiveness [Time frame: 30 years]
Eligibility criteria
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:
- 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
- Ectopic secretion of GH or pituitary cancer
- The patient is diagnosed with other complicated malignancies, or has previously been diagnosed with another malignancy, and there is currently evidence of lesion residue.
- 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.
- Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- China Acromegaly Organization — Guangzhou
Identifiers
NCT: NCT03158090 · Titan