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

Recruiting

• Conditions: Acromegaly
• Interventions: Procedure: Transnasal butterfly surgery; Drug: sandostatin; Radiation: radiotherapy

• Registration Number: NCT03158090
• Lead Sponsor: Ginkgo Leaf Center for Rare Disorders

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.

Study Timeline

• Study First Submitted: 2017-05-06
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-17
• Study Start: 2017-12-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-16
• Primary Completion: 2050-12-30
• Study Completion: 2051-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1965

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical treatment	Transnasal butterfly surgery	The subject was received transnasal butterfly surgery.
Drug therapy	sandostatin	The subject was received drug treatment including somatostatin analogues such as sandostatin and lanreotide, dopamine receptor agonists and GH receptor antagonists.
Radiotherapeutics	radiotherapy	he subject was received radiotherapy methods including radiotherapy, linear accelerator X knife, gamma knife and so on.

Primary Outcome Measures

Name	Time	Method
clinical outcome: overall survival	30 yeas	To compare overall survival of acromegaly in China between receiving surgery, drug and radiotherapeutics treatment

Secondary Outcome Measures

Name	Time	Method
clinical efficacy: control required GH level	30 years	To compare control required GH level of different treatment models (surgery, drug and radiotherapeutics treatment) in patients with acromegaly in China
Cost-effectiveness	30 years	To compare cost for acromegaly of different treatment models (surgery, drug and radiotherapeutics treatment) in patients with acromegaly in China

Trial Locations

Locations (1)

China Acromegaly Organization; 🇨🇳 Guangzhou, Guangdong, China