Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery

The objective of this study is to evaluate, in acromegalic patients with disease persistence after surgery who are treated with somatostatin analogues, the histopathological, clinical, morphological and biochemical factors which are predictive of hormonal control.

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital "Juan Canalejo", A Coruña, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Acromegalic patients with persistent disease (growth hormone ≥ 1ng/ml following oral glucose tolerance test and/or insulin like growth factor 1 above the normal range for sex and age) 3 to 6 months after transsphenoidal or transfrontal surgery

Exclusion criteria

Patients not contributing enough material for a tumour histopathological study
Patients who have received radiation therapy or will receive it during the observational study period
Patients who are being treated, or in whom treatment is anticipated, with either a dopaminergic agonist or a growth hormone receptor antagonist
Patients with a history of hypersensitivity to somatostatin analogues

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Observational Study to Evaluate, in Acromegalic Patients With Disease Persistence After Surgery, Those Histopathologic, Clinical, Morphologic and Biochemical Factors Predictors of Hormonal Control Under Somatostatin Analogue Treatment

Acronym: ESPORA

Important dates

Study start: 2007
Primary completion: 2012
Study completion: 2012
First posted: Jul 12, 2007
Registry last updated: Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed