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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00500227
First received: July 11, 2007
Last updated: July 30, 2012
Last verified: July 2012
  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.


Condition Phase
Acromegaly
Phase 4

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:

Enrollment: 55
Study Start Date: September 2007
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014