AcromegalyACRO-POLISNCT02012127
Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
An observational study of Acromegaly, run by Ipsen at 25 sites in France.
Trial summary
The purpose of this study is to describe most characteristic association of signs and symptoms present at the time of acromegaly diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- How many people
- 648 participants
- Where
- 25 sitesFrance
- Study dates
- Sep 2013to Jun 2014
- 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
Who may be able to join
- Adult patient (greater than or equal to 18 years old)
- Patient with acromegaly, diagnosed for less than 5 years
Who cannot join
- Patient who have objected to the collection of his/her data
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites
Hôpital Sud
Amiens
CHU Besançon Hôpital Jean Minjoz
Besançon
Hôpital la Cavale Blanche
Brest
Chu Cote de Nacre
Caen
Hôpital Henri Mondor
Créteil
Chu de Grenoble Hôpital Albert Michallon
Grenoble
Hôpital Claude Huriez
Lille
Hôpital le Cluzeau
Limoges
Hôpital Neuro-cardiologique
Lyon
Hôpital de la Timone
Marseille
Hôpital Lepeyronie
Montpellier
Hôpitaux de Brabois
Nancy
CHR Orléans - Hôpital la Source
Orléans
CH de Bicetre
Paris
CH Pitie Salpetreire
Paris
Hôpital Lariboisiere
Paris
Hôpital Haut Leveque
Pessac
CHU Reims - Hôpital Robert Debre
Reims
Hôpital Sud Anne de Bretagne
Rennes
CHU Rouen - Hôpital de Bois Guillaume
Rouen
Hôptital Nord
Saint-Etienne
Hôpital Civil
Strasbourg
Hôpital de Hautepierre
Strasbourg
Hôpital Larrey
Toulouse
CHU Bretonneau
Tours
About this study
The purpose of this study is to describe most characteristic association of signs and symptoms present at the time of acromegaly diagnosis.
- Conditions
- Acromegaly
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acromegalic patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the most characteristic sign-and-symptom associations of acromegaly, collected by a patient questionnaire.
Measured: At the time of patient diagnosis, up to 3 months
Secondary outcomes (1)
Description of demographic and clinical characteristics of patients with acromegaly, collected by a patient questionnaire.
Measured: At the time of patient diagnosis, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2014
- Study completionJun 2014
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
- Retrospective
- Enrolment
- 648 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
- NCT02012127
- Sponsor's protocol ID
- A-54-52030-266
- Acronym
- ACRO-POLIS
- Status last verified
- Aug 2019
- First submitted
- 28 Nov 2013
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Caron P, Brue T, Raverot G, Tabarin A, Cailleux A, Delemer B, Renoult PP, Houchard A, Elaraki F, Chanson P. Signs and symptoms of acromegaly at diagnosis: the physician's and the patient's perspectives in the ACRO-POLIS study. Endocrine. 2019 Jan;63(1):120-129. doi: 10.1007/s12020-018-1764-4. Epub 2018 Sep 29.
PubMed 30269264
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
- ClinicalTrials.gov ID
- NCT02012127
- Acronym / sponsor ID
- ACRO-POLIS / A-54-52030-266
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 648 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Dec 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 purpose of this study is to describe most characteristic association of signs and symptoms present at the time of acromegaly diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acromegalic patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acromegalic patients
Key inclusion criteria (2 listed)
- Adult patient (greater than or equal to 18 years old)
- Patient with acromegaly, diagnosed for less than 5 years
Key exclusion criteria (1 listed)
- Patient who have objected to the collection of his/her data
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
Description of the most characteristic sign-and-symptom associations of acromegaly, collected by a patient questionnaire.
Time frame: At the time of patient diagnosis, up to 3 months
1 secondary outcome
Description of demographic and clinical characteristics of patients with acromegaly, collected by a patient questionnaire.
Time frame: At the time of patient diagnosis, up to 3 months
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 5 Aug 2019.
- Derived from this study: PubMed 30269264Caron P, Brue T, Raverot G, Tabarin A, Cailleux A, Delemer B, Renoult PP, Houchard A, Elaraki F, Chanson P. Signs and symptoms of acromegaly at diagnosis: the physician's and the patient's perspectives in the ACRO-POLIS study. Endocrine. 2019 Jan;63(1):120-129. doi: 10.1007/s12020-018-1764-4. Epub 2018 Sep 29.
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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
25 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 25 sites in France.
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 1 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 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France. 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?
Description of the most characteristic sign-and-symptom associations of acromegaly, collected by a patient questionnaire. (time frame: At the time of patient diagnosis, up to 3 months). 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 NCT02012127, 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 5 Aug 2019.