ITMO public health
Last update : 09/09/2019 | Version : 2 | ID : 3107
| General | |
| Identification | |
| Detailed name | Cryoconservation during allogeneic hematopoietic Stem cell transplantation |
| Sign or acronym | CRYOSTEM |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CPP Sud-Méditerranée (17/02/2012) : AC-2011-1420, CCTIRS (09/02/2012) : 11-710bis, CNIL |
| General Aspects | |
| Medical area |
Cancer research Hematology Immunology Infectious diseases Pediatrics |
| Health determinants |
Iatrogenic |
| Keywords | Graft-versus-host-disease, GvHD, Allogeneic Hematopoietic Stem Cell Transplantation, HSCT, Biobanking network, Complications |
| Scientific investigator(s) (Contact) | |
| Name of the director | Peffault De Latour |
| Surname | Régis |
| Address | 1, avenue Claude Vellefaux 75010 PARIS |
| Phone | + 33 (0)1 42 38 50 73 |
| regis.peffaultdelatour@sls.aphp.fr | |
| Unit | Service d'hématologie / Greffe |
| Organization | Hôpital Saint Louis |
| Name of the director | Calmels |
| Surname | Boris |
| Address | 232, boulevard Sainte Marguerite 13009 MARSEILLE |
| Phone | + 33 (0)4 91 22 34 41 |
| calmelsb@ipc.unicancer.fr | |
| Unit | Centre de thérapie cellulaire |
| Organization | Institut Paoli Calmettes |
| Name of the director | Fontenille |
| Surname | Claire |
| Address | 232, boulevard Sainte Marguerite 13009 MARSEILLE |
| Phone | + 33 (0)4 91 22 34 37 |
| claire.fontenille@cryostem.org | |
| Unit | Centre de thérapie cellulaire |
| Organization | Institut Paoli Calmettes |
| Name of the director | Robert |
| Surname | Emilie |
| Address | 232, bd Sainte Marguerite 13009 Marseille |
| Phone | + 33 (0)4 91 22 34 37 |
| emilie.robert@cryostem.org | |
| Unit | Centre de Thérapie Cellulaire |
| Organization | Institut Paoli Calmettes |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Mixed |
| Details | ANR "Investissements d'avenir -Grand emprunt" |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CRYOSTEM |
| Organisation status |
Private |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective |
The goal of CryoStem is to create a national, multicenter, prospectie, longitudinal, standardized HSCT human-sample collection (derived from adult and pediatric patients) with the purpose of enabling better characterization and prediction of HSCT complications occurence and outcome, including GvHD.
CryoStem has generated a French network involving all the French transplant units, adult and pediatric and 28 Biological Resources Centres. Only in a network such as this may the full potential be realized of having concrete and effective interactions between scientists with top knowledge in specific areas and physicians. CryoStem fosters interactions among internationally recognized experts in advanced biotechnology (genomics,transcriptomics, proteomics, and flow cytometry). Altogether, CryoStem provides a structured approach for a range of different research activities, bringing together leading-edge researchers who can access documented biological (CryoStem) and clinical (ProMISe) samples from transplanted patients in order to better characterize and predict HSCT complications. |
| Inclusion criteria | Any patient suffering from a severe blood disease or blood cancer (leukemia, lymphoma, aplastic anemia...) justifying a first HSCT in one of the transplant units of CRYOSTEM network. |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) Early childhood (2 to 5 years) Childhood (6 to 13 years) Adolescence (13 to 18 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | III - Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2012 |
| Date of last collection (YYYY or MM/YYYY) | 2019 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 5 756 patients and 2 375 donors as of August, 31 2019 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | transplant type and date / relapse / graft failure / second transplant / stages and corticoresistance for the acute GvHD / type, classification and evolution of the chronic GvHD |
| Biological data (detail) | Blood samples |
| Presence of a biobank |
Yes |
| Contents of biobank |
Plasma Blood cells isolated Others |
| Details of biobank content | Viable mononuclear cells, plasma, and dried cell pellets |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Data are collected via a unique document filled in as the time of blood samples by the transplant units staff in charge of the patient medical follow-up. |
| Quality procedure(s) used | Sampling and sending / blood samples reception and processing |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Duration of CryoStem : 7 years (inclusion : 6 years) |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Description | The first publications have been submitted during the summer 2019. |
| Other information | The embargo on the CRYOSTEM samples has ended on 2015/04/15. Since 2015, and as of August, 31 2019, almost 7 000 samples have been provided to 10 research projects on GvHD and HSCT complications. |
| Access | |
| Presence of document that lists variables and coding procedures |
Yes |
| Terms of data access (charter for data provision, format of data, availability delay) |
Any investigator selected by CRYOSTEM Scientific Committee commits himself to respect the general terms of the current call of projects to access the collection biological resources.
The investigator could access to demographical and clinical information, extracted from the European register of the EBMT (European Society for Blood and Marrow Transplantation), provided via an Excel file made anonymous. Once selected, CRYOSTEM project managers schedule interviews with the investigators in order to identify and select the samples of interest. The delay of provision depend on the number of the samples waited for. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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