Digestive System DiseaseYesNCT03097731
Epidemiological Screening of IL10RA Mutation Rate in China
An observational study of Digestive System Disease, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 hours to 28 days
- Conditions the study is for
- Digestive System Disease
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 1 Jul 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 hours to 28 days
- All sexes
- Child
Study population: In the study period, all newborns in the selected hospital were included.
Who may be able to join
- In the study period, all newborns in the selected hospita
Who cannot join
- Children whose guardian refused to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of Fudan university
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Epidemiological Screening of p.R101W and p.T179T IL10RA Mutation Rates in Henan Province, China
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.
Read the detailed description
- The mutation rates of p.R101W and p.T179T IL10RA in Henan newborn.
- Is there any clinical symptoms in children with IL-10RA-deficient? and the onset of the symptoms.
- Whether the intestinal permeability is normal in heterozygote subjects.
- Conditions
- Digestive System Disease
- Keywords
- interleukin-10, inflammatory bowel disease
- Medical subject headings
- Digestive System Diseases, Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The mutation rate of IL-10RA in chinese
All present mutations in IL-10RA
Measured: From birth to 3 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 Jul 2019 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2021 (estimated)
Why it stopped: Preliminary tests found that some newborns heel blood amount could not meet the test needs.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Huang, MD and PhD, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097731
- Sponsor's protocol ID
- 20170208
- Acronym
- Yes
- Status last verified
- Apr 2019
- First submitted
- 27 Feb 2017
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Screening of p.R101W and p.T179T IL10RA Mutation Rates in Henan Province, China
- ClinicalTrials.gov ID
- NCT03097731
- Acronym / sponsor ID
- Yes / 20170208
- Conditions
- Digestive System Disease
- Keywords
- interleukin-10, inflammatory bowel disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Preliminary tests found that some newborns heel blood amount could not meet the test needs.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- The mutation rates of p.R101W and p.T179T IL10RA in Henan newborn.
- Is there any clinical symptoms in children with IL-10RA-deficient? and the onset of the symptoms.
- Whether the intestinal permeability is normal in heterozygote subjects.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 24 hours to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- In the study period, all newborns in the selected hospital were included.
Key inclusion criteria (1 listed)
- In the study period, all newborns in the selected hospita
Key exclusion criteria (1 listed)
- Children whose guardian refused to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The mutation rate of IL-10RA in chinese
Time frame: From birth to 3 years old
All present mutations in IL-10RA
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Huang, MD and PhD study director
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digestive System Disease, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mutation rate of IL-10RA in chinese (time frame: From birth to 3 years old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.