AcromegalyACRO QLQNCT02396966
Quality of Life (QoL) in Subjects With Acromegaly Under Lanreotide Autogel® Treatment.
An observational study of Acromegaly, run by Ipsen at 18 sites in Poland.
Trial summary
The purpose of the protocol is to evaluate and describe QoL, in the population of Polish acromegalic patients treated with Lanreotide Autogel® 120 mg during the 24 months (long term observation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- How many people
- 152 participants
- Where
- 18 sitesPoland
- Study dates
- Dec 2014to May 2018
- 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: Specialist care clinic and hospital clinic.
Who may be able to join
- Adult patients with acromegaly treated for at least three months and no longer than three years with Lanreotide Autogel® 120 mg just before inclusion.
- Patients capable of giving their informed consent to participate in the study and who agree to participate by signing the informed consent form.
Who cannot join
- Active participation in any interventional or any other non-interventional acromegaly clinical study. (Previous participation in any interventional or any observational / post marketing study (PMS) of other somatostatin analogue should not be an exclusion criteria).
- Any medical or psychological condition, according to investigator judgement, that might compromise the ability to give informed consent.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Poland18 sites
Study site
Bialystok
Study site
Bydgoszcz
Study site
Bytom
Study site
Gdansk
Study site
Gliwice
Study site
Katowice
Study site
Kielce
Study site
Krakow
Study site
Lodz
Study site
Lublin
Study site
Olsztyn
Study site
Opole
Study site
Poznan
Study site
Rybnik
Study site
Rzeszów
Study site
Szczecin
Study site
Warsaw
Study site
Wroclaw
About this study
Official title: A Prospective, Non-interventional, Observational, Multi-centre Study to Document QoL of Subjects With Acromegaly Under Lanreotide Autogel® Treatment.
The purpose of the protocol is to evaluate and describe QoL, in the population of Polish acromegalic patients treated with Lanreotide Autogel® 120 mg during the 24 months (long term observation).
- Conditions
- Acromegaly
- Medical subject headings
- Acromegaly
What is being measured
The primary outcome is the main question the study is designed to answer.
Acromegaly quality of life (AcroQol) questionnaire
The AcroQol questionnaire and total AcroQol score will be analysed descriptively overall and according to hormonal control, presence of prior radiotherapy, presence of prior surgery.
Measured: Change from baseline (visit 1), visit 3 and 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Secondary outcomes (4)
Hormonal control of serum growth hormone (GH) and insulin-like growth factor 1 (IGF-1) concentration
Descriptive analysis
Measured: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Clinical symptoms of acromegaly
Descriptive analysis of the following symptoms - Headache, Sweating, Joint symptoms and Swelling
Measured: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Patient overall assessment of satisfaction from treatment
Using a Likert scale (from 1 to 5); completely satisfied, rather satisfied, neither satisfied nor dissatisfied, rather dissatisfied, completely dissatisfied.
Measured: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Lanreotide injection interval (28, 42 or 56 days)
Summary of overall and by hormone control status.
Measured: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionMay 2018
- Study completionMay 2018
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 152 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
- NCT02396966
- Sponsor's protocol ID
- A-38-52030-306
- Acronym
- ACRO QLQ
- Status last verified
- Dec 2018
- First submitted
- 18 Mar 2015
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional, Observational, Multi-centre Study to Document QoL of Subjects With Acromegaly Under Lanreotide Autogel® Treatment.
- ClinicalTrials.gov ID
- NCT02396966
- Acronym / sponsor ID
- ACRO QLQ / A-38-52030-306
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 24 Mar 2015 (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 the protocol is to evaluate and describe QoL, in the population of Polish acromegalic patients treated with Lanreotide Autogel® 120 mg during the 24 months (long term observation).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Specialist care clinic and hospital clinic.
Key inclusion criteria (2 listed)
- Adult patients with acromegaly treated for at least three months and no longer than three years with Lanreotide Autogel® 120 mg just before inclusion.
- Patients capable of giving their informed consent to participate in the study and who agree to participate by signing the informed consent form.
Key exclusion criteria (2 listed)
- Active participation in any interventional or any other non-interventional acromegaly clinical study. (Previous participation in any interventional or any observational / post marketing study (PMS) of other somatostatin analogue should not be an exclusion criteria).
- Any medical or psychological condition, according to investigator judgement, that might compromise the ability to give informed consent.
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
Acromegaly quality of life (AcroQol) questionnaire
Time frame: Change from baseline (visit 1), visit 3 and 6 (visits occur approximately every 4-5 months, during 2 years of observation)
The AcroQol questionnaire and total AcroQol score will be analysed descriptively overall and according to hormonal control, presence of prior radiotherapy, presence of prior surgery.
4 secondary outcomes
Hormonal control of serum growth hormone (GH) and insulin-like growth factor 1 (IGF-1) concentration
Time frame: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Clinical symptoms of acromegaly
Time frame: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Patient overall assessment of satisfaction from treatment
Time frame: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Lanreotide injection interval (28, 42 or 56 days)
Time frame: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
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 21 Dec 2018.
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RecruitingObservational study
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RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
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RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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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
18 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 18 sites in Poland.
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 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Poland. 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?
Acromegaly quality of life (AcroQol) questionnaire (time frame: Change from baseline (visit 1), visit 3 and 6 (visits occur approximately every 4-5 months, during 2 years of observation)). It is what the study was designed to measure, not a finding.
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 21 Dec 2018.