Clinical trial NCT00500227: Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2007-07-12
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acromegalic patients with persistence of the disease who attend specialized visits (Endocrinologist) at the Spanish hospitals.

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.


Eligibility criteria: 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

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