Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 32 for:    Interleukin-10

Epidemiological Screening of IL10RA Mutation Rate in China (Yes)

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: NCT03097731
Recruitment Status : Withdrawn (Preliminary tests found that some newborns heel blood amount could not meet the test needs.)
First Posted : March 31, 2017
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Fudan University

Tracking Information
First Submitted Date February 27, 2017
First Posted Date March 31, 2017
Last Update Posted Date May 1, 2019
Estimated Study Start Date July 1, 2019
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2018)
The mutation rate of IL-10RA in chinese [ Time Frame: From birth to 3 years old ]
All present mutations in IL-10RA
Original Primary Outcome Measures
 (submitted: March 30, 2017)
The mutation rate of IL-10RA in chinese [ Time Frame: six months ]
All present mutations in IL-10RA
Change History Complete list of historical versions of study NCT03097731 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epidemiological Screening of IL10RA Mutation Rate in China
Official Title Epidemiological Screening of p.R101W and p.T179T IL10RA Mutation Rates in Henan Province, China
Brief Summary The presentation of IBD in early childhood is uncommon and the monogenetic defects, especially IL-10 signaling pathway play a key role in very early onset inflammatory bowel disease (VEO-IBD). IL-10 or IL-10R deficiency associated VEO-IBD is considered a rare disorder. To date, there were about 60 cases were reported all over the word. But in our Chinese VEO-IBD Collaboration Group, 42 patients with biallelic mutations affecting IL10R genes were identified from 93 VEO-IBD patients, and the mutation sites are highly concentrated, including 83.9% (26/31) with p.R101W and 55% p.T179T (17/31) mutation, and the proportion of patients from Henan( A province of China) is higher. So we speculate that IL-10RA mutation may not be very rare, and the frequency of heterozygote subjects might be higher than suspected.
Detailed Description
  1. The mutation rates of p.R101W and p.T179T IL10RA in Henan newborn.
  2. Is there any clinical symptoms in children with IL-10RA-deficient? and the onset of the symptoms.
  3. Whether the intestinal permeability is normal in heterozygote subjects.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Retention:   Samples With DNA
Description:
Samples will be stored in 4 degrees refrigerator for the future research
Sampling Method Non-Probability Sample
Study Population In the study period, all newborns in the selected hospital were included.
Condition Digestive System Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: April 29, 2019)
0
Original Estimated Enrollment
 (submitted: March 30, 2017)
10000
Estimated Study Completion Date July 1, 2021
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • In the study period, all newborns in the selected hospita

Exclusion Criteria:

  • Children whose guardian refused to participate in the study
Sex/Gender
Sexes Eligible for Study: All
Ages up to 28 Days   (Child)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03097731
Other Study ID Numbers 20170208
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Children's Hospital of Fudan University
Study Sponsor Children's Hospital of Fudan University
Collaborators Not Provided
Investigators
Study Director: Ying Huang, MD and PhD Children's Hospital of Fudan University
PRS Account Children's Hospital of Fudan University
Verification Date April 2019