Lanreotide Levels in Acromegaly

June 9, 2009 updated by: Cedars-Sinai Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from Cedars-Sinai Pituitary Center

Description

Inclusion Criteria:

  • 18 years or older
  • Receiving lanreotide depot for treatment of acromegaly

Exclusion Criteria:

  • Unwilling to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 10, 2009

Study Record Updates

Last Update Posted (Estimate)

June 10, 2009

Last Update Submitted That Met QC Criteria

June 9, 2009

Last Verified

June 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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