Current partner codePEPTIDESDE
NCT03158090·Not applicable·OBSERVATIONAL

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

Status

Recruiting

Phase

Not applicable

Enrollment

1,965

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

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

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

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

Timeline

From registration to results.

  1. First posted

    May 17, 2017

  2. Study start

    Dec 15, 2017

  3. Primary completion

    Dec 30, 2050

  4. Study completion

    Jan 30, 2051

  5. Results posted

    Not reported

  6. Registry updated

    Mar 16, 2022

Outcomes

What the study measures.

Primary outcomes

clinical outcome: overall survival

Time frame · 30 yeas

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

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
Not reported

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: 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

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

China Acromegaly Organization

Guangzhou, Guangdong, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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