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

Ginkgo Leaf Center for Rare Disorders

Status: Enrolling

Conditions: Acromegaly

Treatments: Drug: sandostatin; Radiation: radiotherapy; Procedure: Transnasal butterfly surgery

Study type: Observational

Funder types: Other

Identifiers

NCT03158090

Titan

Details and patient eligibility

About

This study is a prospective, noninteractive, observational, and longitudinal study aimed at assessing the treatment pattern and clinical outcome of acromegaly in China.

Full 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.

Enrollment: 1,965 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,965 participants in 3 patient groups

Surgical treatment

Description:

The subject was received transnasal butterfly surgery.

Treatment:

Procedure: Transnasal butterfly surgery

Drug therapy

Description:

The subject was received drug treatment including somatostatin analogues such as sandostatin and lanreotide, dopamine receptor agonists and GH receptor antagonists.

Treatment:

Drug: sandostatin

Radiotherapeutics

Description:

he subject was received radiotherapy methods including radiotherapy, linear accelerator X knife, gamma knife and so on.

Treatment:

Radiation: radiotherapy