Actively Recruiting

Age: 18Years - 75Years
All Genders
ID03158090

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

Led by Ginkgo Leaf Center for Rare Disorders · Updated on 2022-03-16

1965

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a long-term observational study in China to better understand how acromegaly is treated and how different treatments affect patient outcomes and costs. The study aims to answer important questions about treatment methods, their impact on patients' health, and economic considerations, helping to inform future care decisions for people with acromegaly. Participants receive care guided by their doctors without interference from the study. Treatments include surgical options like transnasal butterfly surgery, drug therapies such as somatostatin analogues (including sandostatin and lanreotide), dopamine receptor agonists, GH receptor antagonists, and various radiotherapy methods like linear accelerator X knife and gamma knife. The study observes these treatments without assigning or changing patient care. During the study, patient medical information is collected confidentially over up to 30 years. Researchers will assess clinical outcomes including overall survival, control of growth hormone levels, and cost-effectiveness of treatments. No changes to patient care occur, and privacy is maintained following international standards. This long-term monitoring helps provide valuable insights into acromegaly management.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be able and willing to sign the informed consent form
  • Male or female, aged 18 to 75 years old
  • Diagnosis of acromegaly confirmed by at least one laboratory or medical record showing random GH ≥ 2.5 µg/L
  • Radiographic evidence of a pituitary tumor shown in at least one checklist or medical record
Not Eligible

You will not qualify if you...

  • Ectopic secretion of growth hormone or pituitary cancer
  • Diagnosis of other complicated malignancies or evidence of lesion residue from previous malignancy
  • Severe acute or chronic medical or psychiatric conditions that may increase risks or interfere with study results
  • Judged inappropriate for enrollment by the Investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 30 years

Participants who undergo routine care for acromegaly are observed. Measurements and medical information are collected before and after their usual treatments including surgery, drug therapy, or radiotherapy.

Visits occur as part of routine care; frequency varies by treatment and patient needs

Trial Site Locations

Total: 1 location

1

China Acromegaly Organization

Guangzhou, Guangdong, China, 510000

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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