AcromegalySOPRANoNCT01840449
Somatuline Predictive Factors in Acromegaly and NET
An observational study of Acromegaly and Neuroendocrine Tumours, run by Ipsen at 3 sites in 3 countries.
Trial summary
The aim of the study is to identify predictive factors for the response to Lanreotide treatment in Acromegaly as well as in Neuroendocrine Tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly, Neuroendocrine Tumours
- What is being tested?
- Somatuline Autogel® 60, 90 or 120 mg
- How many people
- 156 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2012to May 2017
- 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: Clinics and private practitioners who treat acromegaly and/or NET subjects with Somatuline Autogel® 60, 90 or 120 mg.
Who may be able to join
- Written informed consent (also mandatory in case of retrospective documentation of subject data)
- Diagnosis of acromegaly or NET with the intention to be treated with ATG or already on treatment with ATG
Who cannot join
- The subject has already been included in this study
- Participation in an interventional trial
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Non-interventional, Observational Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel® (ATG) Treatment in Subjects With Either Acromegaly or Neuroendocrine Tumours (NET)
The aim of the study is to identify predictive factors for the response to Lanreotide treatment in Acromegaly as well as in Neuroendocrine Tumours.
- Conditions
- Acromegaly, Neuroendocrine Tumours
- Being tested
- Somatuline Autogel® 60, 90 or 120 mg
- Medical subject headings
- Acromegaly, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatuline Autogel® 60, 90 or 120 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Neuroendocrine Tumours | The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations. Receives: Drug: Somatuline Autogel® 60, 90 or 120 mg | |
| Acromegaly | The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations. Receives: Drug: Somatuline Autogel® 60, 90 or 120 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)
Measured: Baseline and 1 year
Secondary outcomes (1)
Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)
Measured: Baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startJun 2012
- Primary completionJul 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 156 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
- NCT01840449
- Sponsor's protocol ID
- A-94-52030-240
- Acronym
- SOPRANo
- Status last verified
- Jan 2019
- First submitted
- 23 Apr 2013
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Rinke A, Maintz C, Muller L, Weber MM, Lahner H, Pavel M, Saeger W, Houchard A, Ungewiss H, Petersenn S. Multicenter, Observational Study of Lanreotide Autogel for the Treatment of Patients with Neuroendocrine Tumors in Routine Clinical Practice in Germany and Austria. Exp Clin Endocrinol Diabetes. 2021 Jul;129(7):500-509. doi: 10.1055/a-1342-2755. Epub 2021 Jul 22.
PubMed 34293802
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
- Non-interventional, Observational Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel® (ATG) Treatment in Subjects With Either Acromegaly or Neuroendocrine Tumours (NET)
- ClinicalTrials.gov ID
- NCT01840449
- Acronym / sponsor ID
- SOPRANo / A-94-52030-240
- Conditions
- Acromegaly, Neuroendocrine Tumours
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 25 Apr 2013 (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 aim of the study is to identify predictive factors for the response to Lanreotide treatment in Acromegaly as well as in Neuroendocrine Tumours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuroendocrine Tumours | – | Drug: Somatuline Autogel® 60, 90 or 120 mgThe subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations. |
| Acromegaly | – | Drug: Somatuline Autogel® 60, 90 or 120 mgThe subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinics and private practitioners who treat acromegaly and/or NET subjects with Somatuline Autogel® 60, 90 or 120 mg.
Key inclusion criteria (2 listed)
- Written informed consent (also mandatory in case of retrospective documentation of subject data)
- Diagnosis of acromegaly or NET with the intention to be treated with ATG or already on treatment with ATG
Key exclusion criteria (2 listed)
- The subject has already been included in this study
- Participation in an interventional trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatuline Autogel® 60, 90 or 120 mg | Drug | Acromegaly, Neuroendocrine Tumours |
Primary outcome
Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)
Time frame: Baseline and 1 year
1 secondary outcome
Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)
Time frame: Baseline and 2 years
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.
- Derived from this study: PubMed 34293802Rinke A, Maintz C, Muller L, Weber MM, Lahner H, Pavel M, Saeger W, Houchard A, Ungewiss H, Petersenn S. Multicenter, Observational Study of Lanreotide Autogel for the Treatment of Patients with Neuroendocrine Tumors in Routine Clinical Practice in Germany and Austria. Exp Clin Endocrinol Diabetes. 2021 Jul;129(7):500-509. doi: 10.1055/a-1342-2755. Epub 2021 Jul 22.
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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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly and Neuroendocrine Tumours, run by Ipsen at 3 sites in 3 countries.
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 2 inclusion and 2 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 3 sites in Austria, Germany, Switzerland. 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.
What does the primary outcome measure?
Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects) (time frame: Baseline and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01840449, which also lists 1 linked publication.
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.