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Lanreotide Levels in Acromegaly

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Cedars-Sinai Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00916916
First received: June 9, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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 Intervention
Acromegaly
Other: Blood draw

Study Type: Observational
Official Title: Lanreotide Levels in Acromegaly

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00916916     History of Changes
Other Study ID Numbers: 15070
Study First Received: June 9, 2009
Last Updated: June 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Acromegaly
Lanreotide

Additional relevant MeSH terms:
Pituitary Diseases
Acromegaly
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hyperpituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Angiopeptin
Lanreotide
Antineoplastic Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014