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

March 14, 2022 updated by: Ginkgo Leaf Center for Rare Disorders
This study is a prospective, noninteractive, observational, and longitudinal study aimed at assessing the treatment pattern and clinical outcome of acromegaly in China.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1965

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • China Acromegaly Organization
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chinese adult acromegaly patients are invited to participate in this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical outcome: overall survival
Time Frame: 30 yeas
To compare overall survival of acromegaly in China between receiving surgery, drug and radiotherapeutics treatment
30 yeas

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 years
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
30 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ginkgo Leaf Center for Rare Disorders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 15, 2017

Primary Completion (ANTICIPATED)

December 30, 2050

Study Completion (ANTICIPATED)

January 30, 2051

Study Registration Dates

First Submitted

May 6, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (ACTUAL)

May 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TITAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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