Trial record 1 of 163 for: Acromegaly

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

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ClinicalTrials.gov Identifier: NCT03158090

Recruitment Status : Recruiting

First Posted : May 17, 2017

Last Update Posted : June 1, 2018

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Ginkgo Leaf Center for Rare Disorders

Study Description

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

Genetic and Rare Diseases Information Center resources: Acromegaly

U.S. FDA Resources

Groups and Cohorts

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

Primary Outcome Measures :

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 :

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
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

Information from the National Library of Medicine

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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:

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

Contacts and Locations

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 History of Changes
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

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