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Genetic Analysis of Children With Cyclic Vomiting Syndrome (CVS) and Migraines

This study is currently recruiting participants.
Verified May 2012 by Medical College of Wisconsin
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
B Li, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00727974
First received: July 31, 2008
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to determine if there are genetic variations that can explain a genetic basis for cyclic vomiting syndrome (CVS), various phenotypes of CVS (e.g. menstrual, Sato, calendar-tied) and migraine headaches (e.g. with aura, without aura, hemiplegic migraine). This information will allow physicians to improve care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding the cause of this disease. This research is being done because many unanswered questions remain regarding children with CVS.


Condition
Vomiting Syndrome
Migraines

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Genetic Analysis of Children With Cyclic Vomiting Syndrome and Migraines

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Identify novel genes that contribute to the risk of CVS using genomewide association analysis approach. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perform genotype-phenotype correlations between genetic profiles and various phenotypes of CVS (e.g. menstrual, Sato, calendar-tied) and migraine headaches (e.g. with aura, without aura, hemiplegic migraine) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

5 ml of blood will be drawn through venipucture from the study subjects, their biological parents and siblings when available. In addition, 4 ml of blood will be drawn for serologic testing.


Estimated Enrollment: 880
Study Start Date: January 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1

Diagnostic Criteria for CVS:

3 or more different episodes of vomiting, normal health between episodes, no abnormal test results to account for vomiting [such as endoscopic biopsies (looking at a body part with a lighted tube), hydronephrosis (water block kidney drainage), cholelithiasis (gallstones), pancreatitis (swelling of the pancreas), and hypoglycemia (too little sugar in the blood)];
2

Diagnostic Criteria for Migraine:

5 or more different headaches, complete return to health in between headaches, headaches last 2-48 hours and get in the way everyday activity, headache affects one side of head, with pounding moderate-to-severe pain, one of the following: nausea, vomiting, photophobia (fear of light), phonophobia (fear of sound).

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Cyclic vomiting syndrome (CVS) may be the most severe recurrent vomiting disorder in humans. CVS is characterized by a sudden onset of rapid-fire vomiting, usually beginning in the early morning hours or upon wakening. It has a peak vomiting intensity of every 5-10 minutes (6-12 emeses) and episodes last between 2 hours and 10 days. These episodes of acute vomiting occur on average once every 2 to 4 weeks. The child returns to completely normal health between vomiting episodes. Children are diagnosed based on their specific vomiting pattern and a lack of positive findings on laboratory testing.

Criteria

Inclusion Criteria:

  • Subjects age 0-21 years old with CVS (different phenotypes). Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent.

Exclusion Criteria:

  • Subjects age > 22 years old Vomiting is not due to CVS or other related condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727974

Locations
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: B Li, MD     414-266-3690     bli@mcw.edu    
Principal Investigator: B Li, MD            
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
Principal Investigator: B UK Li, MD Medical College of Wiconsin
  More Information

No publications provided

Responsible Party: B Li, Professor of Gastroenterology, M.D., Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00727974     History of Changes
Other Study ID Numbers: 08/24, GC 607
Study First Received: July 31, 2008
Last Updated: May 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Genome Wide Scan (GWS)
Mitochondrial scan
Family trios

Additional relevant MeSH terms:
Vomiting
Migraine Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Headache Disorders, Primary
 Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013