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

NCT00727974 | Completed DMC

• 2 other identifiers: 08/24GC 607
• Study Type: observational
• Target: 586
• Locations: 1 country
• Sites: 1

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).

Conditions

Vomiting; Migraines

Keywords

Genome Wide Scan (GWS); Mitochondrial scan; Family trios

Outcome Measures

Primary Outcomes (1)

• Identify novel genes that contribute to the risk of CVS using genomewide association analysis approach.

  3 years

Secondary Outcomes (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)

  3 years

Study Arms (2)

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 Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Subjects age \> 22 years old Vomiting is not due to CVS or other related condition

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's Hospital and Health System Foundation, Wisconsin: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

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.

MeSH Terms

Conditions

Vomiting; Migraine Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Katja Kovacic, MD

  Medical College of Wiconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology, M.D.

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 5, 2008
• Study Start: March 5, 2008
• Primary Completion: June 12, 2013
• Study Completion: June 12, 2013
• Last Updated: December 26, 2019

Record last verified: 2019-12

Locations

US (1)