NCT03158090

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,965

participants targeted

Target at P75+ for all trials

Timeline
301mo left

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Dec 2017Jan 2051

First Submitted

Initial submission to the registry

May 6, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

December 15, 2017

Completed
33.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2050

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2051

Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

33.1 years

First QC Date

May 6, 2017

Last Update Submit

March 14, 2022

Conditions

Acromegaly

Keywords

Acromegaly

Outcome Measures

Primary Outcomes (1)

  • clinical outcome: overall survival

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

    30 yeas

Secondary Outcomes (2)

  • clinical efficacy: control required GH level

    30 years

  • Cost-effectiveness

    30 years

Study Arms (3)

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

Transnasal butterfly surgeryPROCEDURE

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.

Surgical treatment
sandostatinDRUG

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
Drug therapy
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

Radiotherapeutics

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Acromegaly Organization

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Acromegaly

Interventions

OctreotidelanreotideRadiotherapy

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2017

First Posted

May 17, 2017

Study Start

December 15, 2017

Primary Completion (Estimated)

December 30, 2050

Study Completion (Estimated)

January 30, 2051

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations

CN(1)