Histamine Responsiveness in McCune-Albright Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2004 by Children's Mercy Hospital Kansas City.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
KBR
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00318097
First received: April 24, 2006
Last updated: May 1, 2006
Last verified: November 2004
  Purpose

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
McCune-Albright Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Histamine Responsiveness in Patients With McCune-Albright Syndrome

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Estimated Enrollment: 30
Study Start Date: November 2003
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 39 Years
Genders Eligible for Study:   Both
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.
  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: NCT00318097

Contacts
Contact: Angela L Turpin, MD 816-234-3804 aturpin@cmh.edu
Contact: Jill D Jacobson, MD 816-234-3804 jjacobson@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospitals and Clinics Recruiting
Kansas City, Missouri, United States, 64108
Contact: Angela L Turpin, MD    816-234-3804    aturpin@cmh.edu   
Contact: Jill D Jacobson, MD    816-234-3804    jjacobson@cmh.edu   
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
KBR
Investigators
Principal Investigator: Angela L Turpin, MD Children's Mercy Hospital Kansas City
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00318097     History of Changes
Other Study ID Numbers: 03 11-116
Study First Received: April 24, 2006
Last Updated: May 1, 2006
Health Authority: United States: Institutional Review Board

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
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014