Can my patients participate in HIT-CF Europe?
Your patients can participate in this European project when they are 16 years of age* or older at the day of signing the informed consent for biopsy taking. They have to have a confirmed diagnosis of CF and two rare CFTR-mutations (see below: inclusion and exclusion criteria). They also need to be able to make one visit to one of the participating hospitals to collect rectal biopsies for generating intestinal organoids. Also, if they are selected for a clinical trial they will need to visit the hospital for probably 6-8 times.
*18 years or older in some countries because of national laws
Inclusion and exclusion criteria
- Confirmed diagnosis of CF
- Sweat Chloride Concentration >60 mmol/L
- Only patients with rare genotypes can participate in the HIT-CF Europe project. Patients cannot participate if they 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, R553X, W1282X, R1162X, E60X, Q493X, 1717-1G>A, 621+1G>T, 3120+1G>A, 1898+1G->A, CFTRdele2,3 and 2183AA->G
- Patients who have had a lung transplantation
- Patients with any comorbidity that might pose an additional risk in potentially administering study drugs
What is the timeline for this project?
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.
Can I include my patients?
Hospitals that are part of the European Cystic Fibrosis Society – Clinical Trial Network (ECFS-CTN) can participate in the HIT-CF Europe project. After approval of the study by your national Ethical Committee, patients can be included. If your hospital is not part of the ECFS-CTN, but you do want to include persons with CF in the HIT-CF Europe studies, you can contact the HIT-CF Study team or a nearby HIT-CF Europe study site (see below). We can then discuss the best way to make sure your patient can participate in this study.
We strongly support hospitals outside of the ECFS-CTN to forward their patients to HIT-CF Europe study sites.
Also German and Austrian patients will be referred to The Netherlands for inclusion in HIT-CF. For more information on this, please contact our Study team via HITCF@umcutrecht.nl
Is my hospital part of the ECFS-CTN?
All hospitals that are part of the ECFS-CTN can be found on the following website:
Hospitals currently participating in HIT-CF Europe
- UMC Utrecht (The Netherlands)
- UZ Leuven (Belgium)
- UZ Brussel (Belgium) – firstname.lastname@example.org or 02 477 57 65
- Motol University Hospital Prague (Czech Republic) – email@example.com / firstname.lastname@example.org or 702013011
- Hadassah Medical Center Jerusalem (Israel) – email@example.com or 0507 874801
- Schneider Children’s Petah Tikva (Israel) – firstname.lastname@example.org or 972 3 9253654
- Hospital de Santa Maria Lisbon (Portugal)
- Hospital Vall d’Hebron Barcelona (Spain) – email@example.com or 093 4893197
Hospitals in a preparatory phase – not recruiting at this moment
- Stockholm CF center (Sweden)
- Göteborg CF center (Sweden)
- Bordeaux University Hospital (France)
- Rigshospitalet Copenhagen (Denmark)
- Institute of Mother and Child Warsaw (Poland)
- Cologne University Hospital (Germany)
- Azieda Ospedaliera Universitaria Integrata Verona (Italy)
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