We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Histamine Responsiveness in McCune-Albright Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00318097
Recruitment Status : Completed
First Posted : April 26, 2006
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
KBR
Information provided by:
Children's Mercy Hospital Kansas City

Brief Summary:

McCune-Albright syndrome (MAS) is a syndrome caused by a genetic mutation that causes a specific protein in the body called a G protein to be constantly active. Children with McCune-Albright syndrome classically have early puberty, areas of increased skin pigmentation, and bone lesions resulting from the constant activity of the specific protein involved.

Histamines are known to play a role in allergies and related allergic problems. The effects of histamines are controlled by the same G protein that is overly active in McCune-Albright syndrome. Thus, one could predict that patients with McCune-Albright may be at high risk for allergic problems. To date, no studies have documented any form of histamine excess or allergic difficulties in patients with McCune-Albright syndrome. However, the investigators have made the observation that a high percentage of their patients with MAS exhibit a range of allergic symptoms, from mild symptoms, to severe, life-threatening symptoms.

The purpose of this study is to demonstrate increased histamine response by using a histamine skin test in patients with MAS. If increased reactions to histamines can be documented in MAS patients when compared to controls, severe and potentially life threatening allergic reactions in children with MAS could be anticipated and avoided.


Condition or disease
McCune-Albright Syndrome

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Histamine Responsiveness in Patients With McCune-Albright Syndrome
Actual Study Start Date : August 1, 2004
Primary Completion Date : August 1, 2007
Study Completion Date : August 1, 2007


Group/Cohort
MAS patients
patient with clinical diagnosis of MAS
controls
age matched, tanner stage matched controls




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children with MAS ranging from toddlers to young adults.
  • Diagnosis of MAS will be made on a clinical basis. Blood testing is not helpful in this condition, as bone marrow progenitor cells with the Gαs mutation display a survival disadvantage. All patients are mixed chimeras, as this mutation is lethal if it occurs in germline cells.
  • Patients who exhibit two or more of the following clinical findings fit the diagnosis of MAS:

    • GnRH independent precocious puberty
    • Polyostotic fibrous dysplasia
    • Café-au-lait spots with coast of Maine borders and respect for the midline.
    • Non-autoimmune hyperthyroidism.
  • Ten controls will also be recruited from family members of patients with MAS with no known allergies. An additional control group of ten unrelated subjects, also with no known allergies, will be recruited from the Endocrine Clinic for comparison.

Exclusion Criteria:

  • Any MAS patient or control who has not, or cannot, discontinue(d) any home regimens of antihistamines or glucocorticoids (including inhaled steroids) at least seven days prior to skin testing.
  • Any MAS patient or control on tricyclic antidepressants within two weeks prior to skin testing.

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): NCT00318097


Locations
United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
KBR
Investigators
Principal Investigator: Angela L Turpin, MD Children's Mercy Hospital Kansas City

ClinicalTrials.gov Identifier: NCT00318097     History of Changes
Other Study ID Numbers: 03 11-116
First Posted: April 26, 2006    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Keywords provided by Children's Mercy Hospital Kansas City:
McCune Albright Syndrome
Histamine regulation

Additional relevant MeSH terms:
Fibrous Dysplasia, Polyostotic
Fibrous Dysplasia of Bone
Syndrome
Disease
Pathologic Processes
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs