Health TrialsbyHealthPanel

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

ConditionAcromegaly
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorGinkgo Leaf Center for Rare Disorders

About this trial

This study is a prospective, noninteractive, observational, and longitudinal study aimed at assessing the treatment pattern and clinical outcome of acromegaly in China.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

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

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Transnasal butterfly surgery

    Procedure/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.

  • sandostatin

    Drug

    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

  • radiotherapy

    Radiation

    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

Treatment groups

1,965 Participants
are divided into 3 treatment groups
Group A: Surgical treatment1 intervention
Group B: Drug therapy1 intervention
Group C: Radiotherapeutics1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ginkgo Leaf Center for Rare Disorders

Lead sponsor

Source ClinicalTrials.gov
Apply now