Acromegaly
Conditions
Brief summary
The study aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria for starting alternative strategies, and to describe the modalities and the global effectiveness of alternative strategies.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 years or more, suffering from acromegaly * Treatment naïve or treated subject (whatever the previous treatments except Lanreotide 120mg and radiotherapy) who does not achieve biochemical control in the physician's opinion. Requiring a treatment with Somatostatin analog (SSA) * Having performed a Magnetic Resonance Imaging (MRI) to evaluate the tumor size within the previous 12 weeks (post-surgery MRI for operated subjects) * In whom the physician has already decided to initiate a treatment with Lanreotide 120mg as a monotherapy
Exclusion criteria
* Subject previously/currently treated with Lanreotide 120mg * History of radiotherapy for acromegaly * Subject who requires a surgical intervention for relief of any sign or symptom associated with tumor compression * Concomitant prolactin hypersecretion requiring a treatment with dopaminergic agonists * Active neoplastic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects who achieve a safe concentration of random Growth Hormone (GH) (≤2.5 ng/mL) and normal age and sex-matched Insulin-like Growth Factor-1 (IGF-1) concentration of the monotherapy phase. | Month 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| History of acromegaly | Baseline | Description of the date of diagnosis, GH and IGF-1 levels and tumor volume at diagnosis |
| History of treatment | Baseline | Description between the diagnosis of acromegaly and the 1st injection of Lanreotide 120mg (treatments, doses) |
| Achievement of safe concentration of random GH (≤2.5 ng/mL) and normal age- and sex-matched IGF-1 concentrations of the monotherapy phase | Month 12 and 18 | — |
| Raw values at each visit and change from baseline in random Growth Hormone (GH) | Baseline, month 5, 12 and 18 | — |
| Raw values at each visit and change from baseline in overall health status (Patient-Assessed Acromegaly Symptom Questionnaire - PASQ) of the monotherapy phase | Baseline, month 5, 12 and 18 | — |
| Raw values at each visit and change from baseline in the Acromegaly Quality of Life Questionnaire (ACROQoL total score and each dimension) of the monotherapy phase | Baseline, month 5, 12 and 18 | — |
| Description of the GH and Insulin-like Growth Factor-1 (IGF-1) levels when the physician decides to start the first alternative strategy | Day 1 (Visit 5) | Assessed in the alternate strategy phase |
| Profile of subjects | Baseline | Description of demographics, Patient-Assessed Acromegaly Symptom Questionnaire (PASQ) clinical score, PASQ overall health status, tumor volume, comorbidities, GH and IGF-1 levels |
| Number of alternative strategies used during the alternative strategy phase | Month 18 | — |
| Treatments received at least once during the alternative strategy phase | Month 18 | — |
| Proportion of subjects with clinically relevant tumor shrinkage (tumor volume decrease of ≥ 20% versus V1 (month 0) of the monotherapy phase) at V6 (month 18 time point) of the alternative strategy phase | Month 18 | — |
| Change in clinical score (PASQ) between baseline (month 0) of the monotherapy phase and month 18 time point of the alternative strategy phase | Month 18 | — |
| Change in overall health status (PASQ) between baseline (month 0) of the monotherapy phase and month 18 time point of the alternative phase | Month 18 | — |
| Change in Acromegaly Quality of Life Questionnaire (ACROQoL total score and dimensions) between baseline (month 0) of the monotherapy phase and Month 18 time point of the alternative strategy phase | Month 18 | — |
| Proportion of subjects achieving biochemical control (random GH ≤2.5 ng/mL and normal age- and sex-matched IGF-1 concentrations) at month 18 time point of the alternative strategy phase (18 months after the start of the first alternative strategy) | Month 18 | — |
Countries
France
Outcome results
None listed