Clinical trial NCT03158090: The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research
Official title: The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acromegaly
Keywords: Acromegaly
Lead sponsor: Ginkgo Leaf Center for Rare Disorders
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 1965
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese adult acromegaly patients are invited to participate in this study.

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: clinical outcome: overall survival
timeFrame: 30 yeas
Secondary outcomes:
measure: clinical efficacy: control required GH level
timeFrame: 30 years
measure: Cost-effectiveness
timeFrame: 30 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: China Acromegaly Organization
state: Guangdong
Study officials:
References: