An observational study in Acromegaly, sponsored by Ginkgo Leaf Center for Rare Disorders. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by Ginkgo Leaf Center for Rare Disorders · Observational
This study is a prospective, noninteractive, observational, and longitudinal study aimed at assessing the treatment pattern and clinical outcome of acromegaly in China.
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.
202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.
This study's planned enrollment of 1,965 is above the median of 100 across 81 observational studies indexed under Acromegaly.
Browse Acromegaly studies →This is the only study on the registry with Ginkgo Leaf Center for Rare Disorders as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Chinese adult acromegaly patients are invited to participate in this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Compliance with acromegaly diagnostic criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The subject was received transnasal butterfly surgery.
Procedure: Transnasal butterfly surgery
The subject was received drug treatment including somatostatin analogues such as sandostatin and lanreotide, dopamine receptor agonists and GH receptor antagonists.
Drug: sandostatin
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.
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
Also known as: Lanreotide
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
To compare overall survival of acromegaly in China between receiving surgery, drug and radiotherapeutics treatment
Time frame: 30 yeas
clinical efficacy: control required GH level
To compare control required GH level of different treatment models (surgery, drug and radiotherapeutics treatment) in patients with acromegaly in China
Time frame: 30 years
Cost-effectiveness
To compare cost for acromegaly of different treatment models (surgery, drug and radiotherapeutics treatment) in patients with acromegaly in China
Time frame: 30 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2017 (actual). Primary completion is estimated for Dec 2050, 396 months after the start.
Of 26 observational studies under Acromegaly, half reached primary completion within 85 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 263. This study's planned 396 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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