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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00500227
First Posted: July 12, 2007
Last Update Posted: July 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ipsen
July 11, 2007
July 12, 2007
July 31, 2012
September 2007
July 2012   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00500227 on ClinicalTrials.gov Archive Site
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Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Acromegalic patients with persistence of the disease who attend specialized visits (Endocrinologist) at the Spanish hospitals.
Acromegaly
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
July 2012
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00500227
A-92-52030-728
Not Provided
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Ipsen
Ipsen
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Study Director: Eva Pineda, MD Ipsen
Ipsen
July 2012