Long-term assessment of acromegaly treatment patterns and outcomes
The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research
This study looks at how different treatments for acromegaly are working for patients in China and what effects they have over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1965 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ginkgo Leaf Center for Rare Disorders Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03158090 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the treatment patterns and clinical outcomes of patients with acromegaly in China. It will collect medical information without interfering with ongoing treatments, focusing on the effectiveness and economic impact of various treatment modalities. Patients will be assigned unique identification numbers to maintain confidentiality while allowing for data extraction from their medical records. The study adheres to international guidelines for good clinical practice and local privacy laws.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 diagnosed with acromegaly, evidenced by elevated growth hormone levels and radiographic evidence of a pituitary tumor.
Not a fit: Patients with ectopic secretion of growth hormone, pituitary cancer, or other severe medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into effective treatment strategies for acromegaly, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown success in evaluating treatment patterns for acromegaly, but this specific longitudinal approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- China Acromegaly Organization — Guangzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.