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Predictive Value of 3 Months Results on 12 Months Tumor Shrinkage After First-Line Octreotide-LAR Therapy in Patients With Acromegaly


N/A
18 Years
85 Years
Not Enrolling
Both
Acromegaly

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Trial Information

Predictive Value of 3 Months Results on 12 Months Tumor Shrinkage After First-Line Octreotide-LAR Therapy in Patients With Acromegaly


From Jan 1st 1995 to December 31st 2006, all files of patients with newly diagnosed active
acromegaly out of the 297 patients coming to our Department for acromegaly who received
first-line treatment with LAR will be considered for this study.

As our routine procedure, all patients signed an informed consent to approve diagnostic
testing, treatment decision, methods for follow-up and data treatment for scientific
purposes. This study has been conducted in accordance with the Helsinki II Declaration on
human experimentation. This study takes advantage from data collected in a large,
prospective study to investigate the effect of first-line surgery or medical therapy (with
somatostatin analogues and/or dopamine/agonists) on GH, IGF-I, tumor mass, cardiovascular
risk markers, cardiomyopathy, hypertension, metabolic profile and prostate diseases in all
the patients coming for a diagnosis of acromegaly in our Department and approved by our
Ethical Committee the 14/10/97 (no.60/97).


Inclusion Criteria:



- No previous treatment for acromegaly

Exclusion Criteria:

- primary surgery

- concomitant hyperprolactinemia requiring combined somatostatin analogues and
dopamine-agonist treatment

- primary treatment with lanreotide

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

GH and IGF-I age-normalized levels, percent GH and IGF-I suppression and percent tumor shrinkage after 3 months

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Annamaria Colao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Federico II of Naples

Authority:

Italy: National Institute of Health

Study ID:

NeuroendoUnit-8

NCT ID:

NCT00616408

Start Date:

January 1997

Completion Date:

December 2007

Related Keywords:

  • Acromegaly
  • GH
  • IGF-I
  • GH-secreting tumors
  • Octreotide
  • Acromegaly

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