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

January 11, 2019 updated by: Ipsen

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Hospital "Juan Canalejo"
      • Alicante, Spain, 03012
        • Hospital General Universitari d'Alacant
      • Barakaldo, Spain, 48903
        • Hospital de Cruces
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 08035
        • Hospital General de la Vall d´Hebron
      • Barcelona, Spain, 08221
        • Hospital "Mútua de Terrassa"
      • Barcelona, Spain, 08907
        • Hospital Prínceps d'Espanya
      • Getafe, Spain, 28905
        • Hospital Universitario de Getafe
      • Leon, Spain, 24071
        • Complejo Hospitalario de León. Hospital Virgen Blanca.
      • Lugo, Spain, 27004
        • Complejo Hospitalario Xeral-Calde de Lugo
      • Madrid, Spain, 28040
        • Fundación Jimenez Díaz
      • Madrid, Spain, 28035
        • Hospital Universitario Puerta de Hierro
      • Madrid, Spain, 28006
        • Hospital De La Princesa
      • Madrid, Spain, 28046
        • Hospital Universitario "La Paz"
      • Madrid, Spain, 28034
        • Hospital "Ramón y Cajal"
      • Madrid, Spain, 28040
        • Hospital Clínico de Madrid
      • Madrid, Spain, 28041
        • Hospital Universitario "12 de Octubre"
      • Orense, Spain, 32005
        • Complexo Hospitalario de Orense
      • Palma de Mallorca, Spain, 07014
        • Hospital "Son Dureta"
      • Pamplona, Spain, 31008
        • Hospital de Navarra
      • Santa Cruz de Tenerife, Spain, 38010
        • Hospital Nuestra Señora de La Candelaria
      • Santander, Spain, 39008
        • Hospital "Marqués de Valdecilla"
      • Santiago de Compostela, Spain, 15705
        • Hospital Clinico Universitario de Santiago
      • Tarragona, Spain, 43007
        • Hospital "Joan XXIII"
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Valladolid, Spain, 47005
        • Hospital Clínico de Valladolid
      • Vigo, Spain, 36204
        • Complejo Hospitalario Xeral-Cies de Vigo
      • Zaragoza, Spain, 50009
        • Hospital "Miguel Servet"
      • Zaragoza, Spain, 50009
        • Hospital Clínico Universitario "Lozano Blesa"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acromegalic patients with persistence of the disease who attend specialized visits (Endocrinologist) at the Spanish hospitals.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 11, 2007

First Submitted That Met QC Criteria

July 11, 2007

First Posted (Estimate)

July 12, 2007

Study Record Updates

Last Update Posted (Actual)

January 14, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-92-52030-728

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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