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

Completed

• Conditions: Acromegaly

• Registration Number: NCT00500227
• Lead Sponsor: Ipsen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-11
• Study First Submitted QC: 2007-07-11
• Study First Posted: 2007-07-12
• Study Start: 2007-09
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (30)

Hospital Prínceps d'Espanya; 🇪🇸 Barcelona, Spain

Hospital General de la Vall d´Hebron; 🇪🇸 Barcelona, Spain

Hospital "Mútua de Terrassa"; 🇪🇸 Barcelona, Spain

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital de Cruces; 🇪🇸 Barakaldo, Spain

Hospital "Juan Canalejo"; 🇪🇸 A Coruña, Spain

Hospital General Universitari d'Alacant; 🇪🇸 Alicante, Spain

Hospital Universitario de Getafe; 🇪🇸 Getafe, Spain

Hospital "Ramón y Cajal"; 🇪🇸 Madrid, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Hospital "Son Dureta"; 🇪🇸 Palma de Mallorca, Spain

Hospital Nuestra Señora de la Candelaria; 🇪🇸 Santa Cruz de Tenerife, Spain

Hospital Universitario "La Paz"; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario de Santiago; 🇪🇸 Santiago de Compostela, Spain

Hospital Clínico Universitario "Lozano Blesa"; 🇪🇸 Zaragoza, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Complejo Hospitalario Xeral-Calde de Lugo; 🇪🇸 Lugo, Spain

Complejo Hospitalario de León. Hospital Virgen Blanca.; 🇪🇸 Leon, Spain

Hospital de La Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital de Navarra; 🇪🇸 Pamplona, Spain

Hospital "Joan XXIII"; 🇪🇸 Tarragona, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Clínico de Valladolid; 🇪🇸 Valladolid, Spain

Hospital "Miguel Servet"; 🇪🇸 Zaragoza, Spain

Complejo Hospitalario Xeral-Cies de Vigo; 🇪🇸 Vigo, Spain

Complexo Hospitalario de Orense; 🇪🇸 Orense, Spain

Hospital "Marqués de Valdecilla"; 🇪🇸 Santander, Spain

Hospital Universitario "12 de Octubre"; 🇪🇸 Madrid, Spain

Hospital Clínico de Madrid; 🇪🇸 Madrid, Spain