Quality of Life (QoL) in Subjects With Acromegaly Under Lanreotide Autogel® Treatment.
ACRO QLQ
A Prospective, Non-interventional, Observational, Multi-centre Study to Document QoL of Subjects With Acromegaly Under Lanreotide Autogel® Treatment.
1 other identifier
observational
152
1 country
18
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2014
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 18, 2015
CompletedFirst Posted
Study publicly available on registry
March 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedDecember 21, 2018
December 1, 2018
3.4 years
March 18, 2015
December 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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
Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Clinical symptoms of acromegaly
Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Patient overall assessment of satisfaction from treatment
Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Lanreotide injection interval (28, 42 or 56 days)
Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Eligibility Criteria
Specialist care clinic and hospital clinic.
You may qualify if:
- Patients capable of giving their informed consent to participate in the study and who agree to participate by signing the informed consent form.
You may not qualify if:
- Any medical or psychological condition, according to investigator judgement, that might compromise the ability to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (18)
Unknown Facility
Bialystok, Poland
Unknown Facility
Bydgoszcz, Poland
Unknown Facility
Bytom, Poland
Unknown Facility
Gdansk, Poland
Unknown Facility
Gliwice, Poland
Unknown Facility
Katowice, Poland
Unknown Facility
Kielce, Poland
Unknown Facility
Krakow, Poland
Unknown Facility
Lodz, Poland
Unknown Facility
Lublin, Poland
Unknown Facility
Olsztyn, Poland
Unknown Facility
Opole, Poland
Unknown Facility
Poznan, Poland
Unknown Facility
Rybnik, Poland
Unknown Facility
Rzeszów, Poland
Unknown Facility
Szczecin, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Wroclaw, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2015
First Posted
March 24, 2015
Study Start
December 1, 2014
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
December 21, 2018
Record last verified: 2018-12