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

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура 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.
• Препарат 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
• Лучевая терапия 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

Первичные конечные точки

• clinical outcome: overall survival [Срок оценки: 30 yeas]

Вторичные конечные точки (2)

• clinical efficacy: control required GH level [Срок оценки: 30 years]
• Cost-effectiveness [Срок оценки: 30 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• China Acromegaly Organization — Гуанчжоу

Идентификаторы

NCT: NCT03158090 · Titan

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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