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Trial record 1 of 167 for:    Acromegaly
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The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03158090
Recruitment Status : Recruiting
First Posted : May 17, 2017
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Ginkgo Leaf Center for Rare Disorders

Study Description
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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.

Condition or disease Intervention/treatment
Acromegaly Procedure: Transnasal butterfly surgery Drug: sandostatin Radiation: radiotherapy

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 Design
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Study Type : Observational
Estimated Enrollment : 1965 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 30, 2050
Estimated Study Completion Date : January 30, 2051

Resource links provided by the National Library of Medicine

Drug Information available for: Lanreotide

Groups and Cohorts
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Chinese adult acromegaly patients are invited to participate in this study.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158090


Locations
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China, Guangdong
China Acromegaly Organization Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Zhiyong Chen, Doctor    +86 18662702387    xieshengrong81@126.com   
Contact: Ron Xie, Master    +86 13813904039    147392524@qq.com   
Sponsors and Collaborators
Ginkgo Leaf Center for Rare Disorders
More Information
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Responsible Party: Ginkgo Leaf Center for Rare Disorders
ClinicalTrials.gov Identifier: NCT03158090    
Other Study ID Numbers: Titan
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ginkgo Leaf Center for Rare Disorders:
Acromegaly
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Lanreotide
Octreotide
Antineoplastic Agents
Gastrointestinal Agents
Antineoplastic Agents, Hormonal