Genetic Analysis of Children With Cyclic Vomiting Syndrome (CVS) 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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Genetic Analysis of Children With Cyclic Vomiting Syndrome and Migraines|
- Identify novel genes that contribute to the risk of CVS using genomewide association analysis approach. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- 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.
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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)];
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727974
|United States, Wisconsin|
|Children's Hospital of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: B Li, MD 414-266-3690 firstname.lastname@example.org|
|Principal Investigator: B Li, MD|
|Principal Investigator:||B UK Li, MD||Medical College of Wiconsin|