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Lanreotide Levels in Acromegaly

Primary Purpose

Acromegaly

Status
Unknown status
Phase
Locations
United States
Study Type
Observational
Intervention
Blood draw
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Acromegaly focused on measuring Acromegaly, Lanreotide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Unwilling to provide consent

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Arm Label

Lanreotide

Arm Description

Patients taking lanreotide for the treatment of acromegaly.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 9, 2009
Last Updated
June 9, 2009
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00916916
Brief Title
Lanreotide Levels in Acromegaly
Official Title
Lanreotide Levels in Acromegaly
Study Type
Observational

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly, Lanreotide

7. Study Design

8. Arms, Groups, and Interventions

Arm Title
Lanreotide
Arm Description
Patients taking lanreotide for the treatment of acromegaly.
Intervention Type
Other
Intervention Name(s)
Blood draw
Intervention Description
A blood draw will occur to take 10cc of blood to measure lanreotide levels.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Receiving lanreotide depot for treatment of acromegaly Exclusion Criteria: Unwilling to provide consent
Study Population Description
Patients from Cedars-Sinai Pituitary Center
Sampling Method
Non-Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lori Korsakoff, RN
Phone
310-423-2411
Email
korsakoffl@cshs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Akers
Phone
310-423-3395
Email
akersd@cshs.org
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Lanreotide Levels in Acromegaly

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