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NCT Number: NCT03158090

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be able and willing to sign the informed consent form (ICF)
  • Male, female, age 18-75 years old (including 18 years old and 75 years old).
  • 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

  • Ectopic secretion of GH or pituitary cancer
  • The patient is diagnosed with other complicated malignancies, or has previously been diagnosed with another malignancy, and there is currently evidence of lesion residue.
  • 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.
  • Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study

Treatment and study plan

Transnasal butterfly surgery

Procedure

The patient will be treated in accordance with the advice of the local doctor in charge, and this study does not interfere with any treatment of the patient.

sandostatin

Drug

The patient will be treated in accordance with the advice of the local doctor in charge, and this study does not interfere with any treatment of the patient

Other names: Lanreotide

Radiotherapy

Radiation

The patient will be treated in accordance with the advice of the local doctor in charge, and this study does not interfere with any treatment of the patient

Primary outcomes

  1. clinical outcome: overall survival

    Time frame: 30 yeas

    To compare overall survival of acromegaly in China between receiving surgery, drug and radiotherapeutics treatment

Secondary outcomes

  1. clinical efficacy: control required GH level

    Time frame: 30 years

    To compare control required GH level of different treatment models (surgery, drug and radiotherapeutics treatment) in patients with acromegaly in China

  2. Cost-effectiveness

    Time frame: 30 years

    To compare cost for acromegaly of different treatment models (surgery, drug and radiotherapeutics treatment) in patients with acromegaly in China

Sponsors and collaborators

Lead sponsor

Ginkgo Leaf Center for Rare Disorders

Other

Registry information

Important dates

Study start
2017
Primary completion
2050
Study completion
2051
First posted
May 17, 2017
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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