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

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

Recruiting
18-75 years
All
Phase N/A

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Overview

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.

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 details
    Acromegaly

NCT03158090

Ginkgo Leaf Center for Rare Disorders

26 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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