Lanreotide Levels in Acromegaly

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ClinicalTrials.gov Identifier: NCT00916916

Recruitment Status : Unknown

Verified June 2009 by Cedars-Sinai Medical Center.
Recruitment status was: Recruiting

First Posted : June 10, 2009

Last Update Posted : June 10, 2009

Sponsor:

Information provided by:

Cedars-Sinai Medical Center

Study Description

Brief Summary:

Recently lanreotide (a somatostatin analog) has come into the US marketplace as a commercially available medication approved by the FDA for the treatment of acromegaly. Blood levels in patients getting this drug are unknown and it may be critical to know the levels in patients whose symptoms are poorly controlled.

This is a clinical study of a medical device where the following condition is met: This is research on a medical device for which an investigational device exemption application (21 CFR Part 812) is not required.

The study is exempt from IDE requirements under 21 CFR 812.2(c)(3):

The participants will be 10 CSMC patients who are taking Lanreotide for clinical purposes. After receiving an information sheet and providing verbal consent, the participants will go to their routine blood draw. At this time, they will have an additional 10 cc plasma drawn, which will be sent to Intersciences Institute in Inglewood California to have the lanreotide plasma levels measured.

The key points of this study are:

Patients will have blood drawn at the same time as they are having blood drawn for routine care to avoid unnecessary sticks.

No patient identifiers will be sent to the lab or to any investigators- all plasma tubes will be coded by ISI as a kit and these kits will be given to the physicians. In turn the physician will give the kit to the patients who wish to have their levels measured and the patient will take the kit with them to their routine blood draw. Following the drawing and processing of the blood we will request that the lab just drop the coded plasma tube (and the patient's height weight and monthly lanreotide dose) into the mail in the prepaid mailer. The only information that the investigators will receive is the patient's height, weight and monthly lanreotide dose and the plasma lanreotide level.

No more than 10 cc of blood (a couple of tablespoons) will be drawn for lanreotide measurement.

Whenever possible plasma (which would otherwise be discarded) will be used rather than freshly drawn blood.

All plasma will be assayed at ISI.

The patient will not be charged for the lanreotide assay, an investigational assay. The assay is currently investigational and does not have a "maker" at this time.

Condition or disease	Intervention/treatment
Acromegaly	Other: Blood draw

Study Design


Study Type :	Observational
Official Title:	Lanreotide Levels in Acromegaly

Resource links provided by the National Library of Medicine

Drug Information available for: Lanreotide Lanreotide acetate

Genetic and Rare Diseases Information Center resources: Acromegaly

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Lanreotide Patients taking lanreotide for the treatment of acromegaly.	Other: Blood draw A blood draw will occur to take 10cc of blood to measure lanreotide levels.

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients from Cedars-Sinai Pituitary Center

Criteria

Inclusion Criteria:

18 years or older
Receiving lanreotide depot for treatment of acromegaly

Exclusion Criteria:

Unwilling to provide consent

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916916

Contacts


Contact: Lori Korsakoff, RN	310-423-2411	korsakoffl@cshs.org
Contact: Daniel Akers	310-423-3395	akersd@cshs.org

Locations


United States, California
Cedars-Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

More Information


ClinicalTrials.gov Identifier:	NCT00916916 History of Changes
Other Study ID Numbers:	15070
First Posted:	June 10, 2009 Key Record Dates
Last Update Posted:	June 10, 2009
Last Verified:	June 2009

Keywords provided by Cedars-Sinai Medical Center:


Acromegaly Lanreotide

Additional relevant MeSH terms:


Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases	Nervous System Diseases Endocrine System Diseases Lanreotide Angiopeptin Somatostatin Antineoplastic Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

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