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

NCT ID: NCT03158090

Last Updated: 2022-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1965 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-15

Study Completion Date

2051-01-30

Brief Summary

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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

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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.

Conditions

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Acromegaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Surgical treatment

The subject was received transnasal butterfly surgery.

Transnasal butterfly surgery

Intervention Type 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.

Drug therapy

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

sandostatin

Intervention Type 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

Radiotherapeutics

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

radiotherapy

Intervention Type 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

Interventions

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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.

Intervention Type PROCEDURE

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

Intervention Type DRUG

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

Intervention Type RADIATION

Other Intervention Names

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Lanreotide

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ginkgo Leaf Center for Rare Disorders

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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China Acromegaly Organization

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Zhiyong Chen, Doctor

Role: primary

+86 18662702387

Ron Xie, Master

Role: backup

+86 13813904039

Other Identifiers

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Titan

Identifier Type: -

Identifier Source: org_study_id

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