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

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: NCT00727974
Recruitment Status : Completed
First Posted : August 5, 2008
Last Update Posted : December 26, 2019
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Katja Kovacic, Medical College of Wisconsin

Brief Summary:
The purpose of this study is to determine if there are genetic variations that can explain a genetic basis for cyclic vomiting syndrome (CVS).

Condition or disease
Vomiting Migraines

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 586 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Genetic Analysis of Children With Cyclic Vomiting Syndrome and Migraines
Actual Study Start Date : March 5, 2008
Actual Primary Completion Date : June 12, 2013
Actual Study Completion Date : June 12, 2013

Resource links provided by the National Library of Medicine


Group/Cohort
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).




Primary Outcome Measures :
  1. Identify novel genes that contribute to the risk of CVS using genomewide association analysis approach. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. 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 ]

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.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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): NCT00727974


Locations
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United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
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Principal Investigator: Katja Kovacic, MD Medical College of Wiconsin

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Responsible Party: Katja Kovacic, Professor of Gastroenterology, M.D., Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00727974    
Other Study ID Numbers: 08/24
GC 607
First Posted: August 5, 2008    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Keywords provided by Katja Kovacic, Medical College of Wisconsin:
Genome Wide Scan (GWS)
Mitochondrial scan
Family trios
Additional relevant MeSH terms:
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Migraine Disorders
Vomiting
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms