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

This study is currently recruiting participants.
Verified August 2013 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: August 21, 2013
Last verified: August 2013

July 31, 2008
August 21, 2013
January 2008
December 2015   (final data collection date for primary outcome measure)
Identify novel genes that contribute to the risk of CVS using genomewide association analysis approach. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00727974 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Genetic Analysis of Children With Cyclic Vomiting Syndrome (CVS) and Migraines
Genetic Analysis of Children With Cyclic Vomiting Syndrome and Migraines

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Probability Sample

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.

  • Vomiting Syndrome
  • Migraines
Not Provided
  • 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).

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
880
December 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
up to 21 Years
No
Not Provided
United States
 
NCT00727974
08/24, GC 607
Yes
B Li, Medical College of Wisconsin
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Principal Investigator: B UK Li, MD Medical College of Wiconsin
Medical College of Wisconsin
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP