AcromegalyNCT03158090
The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research
An observational study of Acromegaly, run by Ginkgo Leaf Center for Rare Disorders at 1 site in China.
Trial summary
This study is a prospective, noninteractive, observational, and longitudinal study aimed at assessing the treatment pattern and clinical outcome of acromegaly in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- Transnasal butterfly surgery, sandostatin and radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 1,965 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2017to 30 Jan 2051
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Chinese adult acromegaly patients are invited to participate in this study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China Acromegaly Organization
Guangzhou, Guangdong, 510000
Zhiyong Chen, Doctor, +86 18662702387, xieshengrong81@126.com
Ron Xie, Master, +86 13813904039, 147392524@qq.com
About this study
This study is a prospective, noninteractive, observational, and longitudinal study aimed at assessing the treatment pattern and clinical outcome of acromegaly in China.
Read the 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.
- Conditions
- Acromegaly
- Being tested
- Transnasal butterfly surgery, sandostatin, radiotherapy
- Keywords
- Acromegaly
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal butterfly surgeryProcedure or 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.
sandostatinDrug
Also called 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
radiotherapyRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | The subject was received transnasal butterfly surgery. Receives: Procedure: Transnasal butterfly surgery | |
| Drug therapy | The subject was received drug treatment including somatostatin analogues such as sandostatin and lanreotide, dopamine receptor agonists and GH receptor antagonists. Receives: Drug: sandostatin | |
| Radiotherapeutics | he subject was received radiotherapy methods including radiotherapy, linear accelerator X knife, gamma knife and so on. Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical outcome: overall survival
To compare overall survival of acromegaly in China between receiving surgery, drug and radiotherapeutics treatment
Measured: 30 yeas
Secondary outcomes (2)
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
Measured: 30 years
Cost-effectiveness
To compare cost for acromegaly of different treatment models (surgery, drug and radiotherapeutics treatment) in patients with acromegaly in China
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start15 Dec 2017
- Primary completion30 Dec 2050 (estimated)
- Study completion30 Jan 2051 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,965 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ginkgo Leaf Center for Rare Disorders
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158090
- Sponsor's protocol ID
- Titan
- Status last verified
- Mar 2022
- First submitted
- 6 May 2017
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research
- ClinicalTrials.gov ID
- NCT03158090
- Acronym / sponsor ID
- Titan
- Conditions
- Acromegaly
- Keywords
- Acromegaly
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,965 participants (estimated)
- Lead sponsor
- Ginkgo Leaf Center for Rare DisordersUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 30 Dec 2050 (estimated)
- Study completion
- 30 Jan 2051 (estimated)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | – | Procedure: Transnasal butterfly surgeryThe subject was received transnasal butterfly surgery. |
| Drug therapy | – | Drug: sandostatinThe subject was received drug treatment including somatostatin analogues such as sandostatin and lanreotide, dopamine receptor agonists and GH receptor antagonists. |
| Radiotherapeutics | – | Radiation: radiotherapyhe subject was received radiotherapy methods including radiotherapy, linear accelerator X knife, gamma knife and so on. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chinese adult acromegaly patients are invited to participate in this study.
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transnasal butterfly surgeryThe 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. | Procedure or surgery | Surgical treatment |
| sandostatinAlso: LanreotideThe 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 | Drug therapy |
| radiotherapyThe 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 | Radiation | Radiotherapeutics |
Primary outcome
clinical outcome: overall survival
Time frame: 30 yeas
To compare overall survival of acromegaly in China between receiving surgery, drug and radiotherapeutics treatment
2 secondary outcomes
clinical efficacy: control required GH level
Time frame: 30 years
Cost-effectiveness
Time frame: 30 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Acromegaly
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RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
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An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by Ginkgo Leaf Center for Rare Disorders at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical outcome: overall survival (time frame: 30 yeas). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.