AcromegalyESPORANCT00500227
Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
An observational study of Acromegaly, run by Ipsen at 30 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- How many people
- 55 participants
- Where
- 30 sitesSpain
- Study dates
- Sep 2007to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acromegalic patients with persistence of the disease who attend specialized visits (Endocrinologist) at the Spanish hospitals.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Spain30 sites
Hospital "Juan Canalejo"
A Coruña, 15006
Hospital General Universitari d'Alacant
Alicante, 03012
Hospital de Cruces
Barakaldo, 48903
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital General de la Vall d´Hebron
Barcelona, 08035
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036
Hospital "Mútua de Terrassa"
Barcelona, 08221
Hospital Prínceps d'Espanya
Barcelona, 08907
Hospital Universitario de Getafe
Getafe, 28905
Complejo Hospitalario de León. Hospital Virgen Blanca.
León, 24071
Complejo Hospitalario Xeral-Calde de Lugo
Lugo, 27004
Hospital de La Princesa
Madrid, 28006
Hospital "Ramón y Cajal"
Madrid, 28034
Hospital Universitario Puerta de Hierro
Madrid, 28035
Fundación Jiménez Díaz
Madrid, 28040
Hospital Clínico de Madrid
Madrid, 28040
Hospital Universitario "12 de Octubre"
Madrid, 28041
Hospital Universitario "La Paz"
Madrid, 28046
Complexo Hospitalario de Orense
Ourense, 32005
Hospital "Son Dureta"
Palma de Mallorca, 07014
Hospital de Navarra
Pamplona, 31008
Hospital Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, 38010
Hospital "Marqués de Valdecilla"
Santander, 39008
Hospital Clínico Universitario de Santiago
Santiago de Compostela, 15705
Hospital "Joan XXIII"
Tarragona, 43007
Hospital Clínico Universitario de Valencia
Valencia, 46010
Hospital Clínico de Valladolid
Valladolid, 47005
Complejo Hospitalario Xeral-Cies de Vigo
Vigo, 36204
Hospital "Miguel Servet"
Zaragoza, 50009
Hospital Clínico Universitario "Lozano Blesa"
Zaragoza, 50009
About this study
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
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.
- Conditions
- Acromegaly
- Medical subject headings
- Acromegaly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500227
- Sponsor's protocol ID
- A-92-52030-728
- Acronym
- ESPORA
- Status last verified
- Jan 2019
- First submitted
- 11 Jul 2007
- Last updated
- 14 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00500227
- Acronym / sponsor ID
- ESPORA / A-92-52030-728
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acromegalic patients with persistence of the disease who attend specialized visits (Endocrinologist) at the Spanish hospitals.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by Ipsen at 30 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.