Last reviewed · How we verify
NCT03097731: Yes
Epidemiological Screening of IL10RA Mutation Rate in China
trial in Digestive System Disease. Withdrawn.
1 July 2020
Quick facts
| Lead sponsor | Children's Hospital of Fudan University |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 1 July 2019 |
| Primary completion | 1 July 2020 |
| Estimated completion | 1 July 2021 |
| Sites | 1 location across China |
Conditions studied
- Digestive System Disease — all drugs for Digestive System Disease →
Sponsor
Children's Hospital of Fudan University
Who can join
Adults 24 Hours to 28 Days, any sex, with Digestive System Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03097731
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03097731 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Fudan University
- Last refreshed: 1 May 2019
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