Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
ESPORA
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
1 other identifier
observational
55
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2007
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2007
CompletedFirst Posted
Study publicly available on registry
July 12, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJanuary 14, 2019
January 1, 2019
4.8 years
July 11, 2007
January 11, 2019
Conditions
Eligibility Criteria
Acromegalic patients with persistence of the disease who attend specialized visits (Endocrinologist) at the Spanish hospitals.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (30)
Hospital "Juan Canalejo"
A Coruña, 15006, Spain
Hospital General Universitari d'Alacant
Alicante, 03012, Spain
Hospital de Cruces
Barakaldo, 48903, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital General de la Vall d´Hebron
Barcelona, 08035, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036, Spain
Hospital "Mútua de Terrassa"
Barcelona, 08221, Spain
Hospital Prínceps d'Espanya
Barcelona, 08907, Spain
Hospital Universitario de Getafe
Getafe, 28905, Spain
Complejo Hospitalario de León. Hospital Virgen Blanca.
León, 24071, Spain
Complejo Hospitalario Xeral-Calde de Lugo
Lugo, 27004, Spain
Hospital de La Princesa
Madrid, 28006, Spain
Hospital "Ramón y Cajal"
Madrid, 28034, Spain
Hospital Universitario Puerta de Hierro
Madrid, 28035, Spain
Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Clínico de Madrid
Madrid, 28040, Spain
Hospital Universitario "12 de Octubre"
Madrid, 28041, Spain
Hospital Universitario "La Paz"
Madrid, 28046, Spain
Complexo Hospitalario de Orense
Ourense, 32005, Spain
Hospital "Son Dureta"
Palma de Mallorca, 07014, Spain
Hospital de Navarra
Pamplona, 31008, Spain
Hospital Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, 38010, Spain
Hospital "Marqués de Valdecilla"
Santander, 39008, Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, 15705, Spain
Hospital "Joan XXIII"
Tarragona, 43007, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital Clínico de Valladolid
Valladolid, 47005, Spain
Complejo Hospitalario Xeral-Cies de Vigo
Vigo, 36204, Spain
Hospital "Miguel Servet"
Zaragoza, 50009, Spain
Hospital Clínico Universitario "Lozano Blesa"
Zaragoza, 50009, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2007
First Posted
July 12, 2007
Study Start
September 1, 2007
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
January 14, 2019
Record last verified: 2019-01