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 : March 16, 2022
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Condition or disease | Intervention/treatment |
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Acromegaly | Procedure: Transnasal butterfly surgery Drug: sandostatin Radiation: radiotherapy |
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 |
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 |

Group/Cohort | Intervention/treatment |
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Surgical treatment
The subject was received transnasal butterfly surgery.
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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.
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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.
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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 |
- clinical outcome: overall survival [ Time Frame: 30 yeas ]To compare overall survival of acromegaly in China between receiving surgery, drug and radiotherapeutics treatment
- 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

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.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
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).
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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

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
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 |
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: | March 16, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Acromegaly |
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 |