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NCT00500227 Clinical Trial

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

Acromegaly Clinical Trial

— ESPORA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00500227
Other study ID # A-92-52030-728
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2007
Est. completion date July 2012

Study information
Verified date January 2019
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Hospital "Juan Canalejo" A Coruña
Spain Hospital General Universitari d'Alacant Alicante
Spain Hospital de Cruces Barakaldo
Spain Hospital "Mútua de Terrassa" Barcelona
Spain Hospital Clínic i Provincial de Barcelona Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital General de la Vall d´Hebron Barcelona
Spain Hospital Prínceps d'Espanya Barcelona
Spain Hospital Universitario de Getafe Getafe
Spain Complejo Hospitalario de León. Hospital Virgen Blanca. Leon
Spain Complejo Hospitalario Xeral-Calde de Lugo Lugo
Spain Fundación Jiménez Díaz Madrid
Spain Hospital "Ramón y Cajal" Madrid
Spain Hospital Clínico de Madrid Madrid
Spain Hospital de La Princesa Madrid
Spain Hospital Universitario "12 de Octubre" Madrid
Spain Hospital Universitario "La Paz" Madrid
Spain Hospital Universitario Puerta de Hierro Madrid
Spain Complexo Hospitalario de Orense Orense
Spain Hospital "Son Dureta" Palma de Mallorca
Spain Hospital de Navarra Pamplona
Spain Hospital Nuestra Señora de la Candelaria Santa Cruz de Tenerife
Spain Hospital "Marqués de Valdecilla" Santander
Spain Hospital Clínico Universitario de Santiago Santiago de Compostela
Spain Hospital "Joan XXIII" Tarragona
Spain Hospital Clínico Universitario de Valencia Valencia
Spain Hospital Clínico de Valladolid Valladolid
Spain Complejo Hospitalario Xeral-Cies de Vigo Vigo
Spain Hospital "Miguel Servet" Zaragoza
Spain Hospital Clínico Universitario "Lozano Blesa" Zaragoza

Sponsors (1)
Lead Sponsor Collaborator
Ipsen

Country where clinical trial is conducted

Spain, 

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