CClinicalTrials.gg
RecruitingNCT03158090Updated Mar 16, 2022

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

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

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,965
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Acromegaly

Browse trials for

Keywords

  • Acromegaly
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Chinese adult acromegaly patients are invited to participate in this study.

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

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
04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,965 participants (estimated)
Patient registry
No

Groups and cohorts

  • Surgical treatment

    The subject was received transnasal butterfly surgery.

    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.

    Drug: sandostatin

  • Radiotherapeutics

    he subject was received radiotherapy methods including radiotherapy, linear accelerator X knife, gamma knife and so on.

    Radiation: radiotherapy

Interventions

  • ProcedureTransnasal 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.

  • Drugsandostatin

    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

  • Radiationradiotherapy

    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

05

What researchers measure

Primary outcomes

  1. clinical outcome: overall survival

    To compare overall survival of acromegaly in China between receiving surgery, drug and radiotherapeutics treatment

    Time frame: 30 yeas

Secondary outcomes

  1. 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

  2. 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

06

Study locations

1 of 1 sites recruiting
  • China Acromegaly Organization
    Guangzhou, Guangdong 510000, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03158090
Lead sponsor
Ginkgo Leaf Center for Rare Disorders
Responsible party
Sponsor
First posted
May 17, 2017
Start date
Dec 15, 2017
Primary completion
Dec 30, 2050 (estimated)
Completion
Jan 30, 2051 (estimated)
Last update
Mar 16, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion