Can I participate?
You can participate in this European project when you are 16 years of age* or older at the day of signing the informed consent for biopsy taking. You have to have a confirmed diagnosis of CF and a rare genetic profile (see below: Is my genetic profile rare?). You also need to be able to make one visit to one of the participating hospitals to collect rectal biopsies for making your unique organoids. Also, if you will be selected for a clinical trial you will need to visit this hospital for probably 6-8 times.
*18 years or older in some countries because of national laws
Is my genetic profile rare?
Only patients with rare genotypes can participate in the HIT-CF Europe project. You cannot participate if you have :
- one of the following mutations: F508del, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, R117H, A455E, 3849+10kbC>T, or
- a combination of any two of the following mutations: G542X, 1717-1G>A, 621+1G>T, 3120+1G>A, 1898+1G->A, CFTRdele2,3 and 2183AA->G
What are additional inclusion and exclusion criteria?
Inclusion criteria -> you can participate if:
- You have a confirmed diagnosis of CF by your doctor. CF must have been diagnosed by the following:
- The new-born screen or one or more CF symptoms or sibling(s) with CF
- Your sweat test result (SSC) is higher than 60 mmol/L
Exclusion criteria -> you cannot participate in this project if:
- You have an additional disease (comorbidity) that increases the risk of administering a drug candidate if you would be selected for a clinical trial. For example, you have severe liver disease. During your first visit for the project the investigator will decide whether you have a comorbidity that might put you at risk for this study.
- You have had a lung transplantation
What is the timeline for this project?
You can apply for participating in this project from March 2018 onwards in one of the participating CF-centers. From April 2018 on biopsies will be taken from 500 people with CF .
The subsequent laboratory tests of drug candidates on organoids will be finished by June 2020.
Based on the responses in organoids, 75 patients will be selected for clinical trials. The clinical trials with the drug candidates will start at the second half of 2020.
The HIT-CF Europe project will be carried out in specific CF-Centers of the Clinical Trial Network (CTN) of the European CF Society (ECFS) (see map).
Recruitment has ended in February 2020. 47 sites from 16 countries throughout Europe contributed to enroll 502 patients.
For more information, you can also contact HIT-CF Europe directly via HITCF@umcutrecht.nl.
Additional important information
If you sign an additional consent, your mini-intestines will be stored in a biobank for future research.
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