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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 11, 2007

Last Updated Date

July 30, 2012

Start Date ^ICMJE

September 2007

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00500227 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Acromegaly

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2012

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00500227

Other Study ID Numbers ^ICMJE

A-92-52030-728

Has Data Monitoring Committee

Not Provided

Responsible Party

Ipsen

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Eva Pineda, MD

Ipsen

Information Provided By

Ipsen

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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