Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery (ESPORA)
This study has been completed.
Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00500227
First received: July 11, 2007
Last updated: July 30, 2012
Last verified: July 2012
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Purpose
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.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Ipsen:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Acromegalic patients with persistence of the disease who attend specialized visits (Endocrinologist) at the Spanish hospitals.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500227
Locations
| Spain | |
| Hospital "Juan Canalejo" | |
| A Coruña, Spain, 15006 | |
| Hospital General Universitari d'Alacant | |
| Alicante, Spain, 03012 | |
| Hospital de Cruces | |
| Barakaldo, Spain, 48903 | |
| Hospital Prínceps d'Espanya | |
| Barcelona, Spain, 08907 | |
| Hospital de la Santa Creu i Sant Pau | |
| Barcelona, Spain, 08025 | |
| Hospital "Mútua de Terrassa" | |
| Barcelona, Spain, 08221 | |
| Hospital General de la Vall d´Hebron | |
| Barcelona, Spain, 08035 | |
| Hospital Clínic i Provincial de Barcelona | |
| Barcelona, Spain, 08036 | |
| Hospital Universitario de Getafe | |
| Getafe, Spain, 28905 | |
| Complejo Hospitalario de León. Hospital Virgen Blanca. | |
| Leon, Spain, 24071 | |
| Complejo Hospitalario Xeral-Calde de Lugo | |
| Lugo, Spain, 27004 | |
| Hospital Universitario "La Paz" | |
| Madrid, Spain, 28046 | |
| Hospital de La Princesa | |
| Madrid, Spain, 28006 | |
| Hospital "Ramón y Cajal" | |
| Madrid, Spain, 28034 | |
| Fundación Jiménez Díaz | |
| Madrid, Spain, 28040 | |
| Hospital Clínico de Madrid | |
| Madrid, Spain, 28040 | |
| Hospital Universitario "12 de Octubre" | |
| Madrid, Spain, 28041 | |
| Hospital Universitario Puerta de Hierro | |
| Madrid, Spain, 28035 | |
| Complexo Hospitalario de Orense | |
| Orense, Spain, 32005 | |
| Hospital "Son Dureta" | |
| Palma de Mallorca, Spain, 07014 | |
| Hospital de Navarra | |
| Pamplona, Spain, 31008 | |
| Hospital Nuestra Señora de la Candelaria | |
| Santa Cruz de Tenerife, Spain, 38010 | |
| Hospital "Marqués de Valdecilla" | |
| Santander, Spain, 39008 | |
| Hospital Clínico Universitario de Santiago | |
| Santiago de Compostela, Spain, 15705 | |
| Hospital "Joan XXIII" | |
| Tarragona, Spain, 43007 | |
| Hospital Clínico Universitario de Valencia | |
| Valencia, Spain, 46010 | |
| Hospital Clínico de Valladolid | |
| Valladolid, Spain, 47005 | |
| Complejo Hospitalario Xeral-Cies de Vigo | |
| Vigo, Spain, 36204 | |
| Hospital "Miguel Servet" | |
| Zaragoza, Spain, 50009 | |
| Hospital Clínico Universitario "Lozano Blesa" | |
| Zaragoza, Spain, 50009 | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Eva Pineda, MD | Ipsen |
More Information
No publications provided
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT00500227 History of Changes |
| Other Study ID Numbers: | A-92-52030-728 |
| Study First Received: | July 11, 2007 |
| Last Updated: | July 30, 2012 |
| Health Authority: | Spain: Ministry of Health |
Additional relevant MeSH terms:
|
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Somatostatin Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013