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13674
Beschreibung
The Cell Therapy Registry (CTR) aims to collect data on fetal or adult stem cells, or progenitor cells used for treatment other than haematopoietic stem cell transplantation or donor lymphocyte infusion, as well as data on the clinical characteristics and outcome of the patients. Data will be collected on characteristics of the cell graft, /in/ or /ex vivo/ cell manipulation and the cell origin (autologous versus allogeneic). Data will include details on patients treated with mesenchymal cells, for instance, to enhance haematopoietic engraftment, for prophylaxis and treatment of GvHD. The registry will also include data on patients treated by other disciplines for neurologic, rheumatologic, cardiac and inflammatory bowel diseases and tissue regeneration. For further information, please contact: please refer: http://www.ebmt.org/Contents/Data-Management/Registrystructure/MED-ABdatacollectionforms/Pages/MED-AB-data-collection-forms.aspx
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- 26.02.16 26.02.16 -
- 11.07.16 11.07.16 -
- 27.09.21 27.09.21 -
Hochgeladen am
26. Februar 2016
DOI
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Creative Commons BY-NC 3.0
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Cell Therapy Registry EBMT
4pp Cell Therapy Registry 25CTR.pdf
- StudyEvent: ODM
Ähnliche Modelle
4pp Cell Therapy Registry 25CTR.pdf
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
First report – 6 months after cell therapy
Item
First report – 6 months after cell therapy
text
OrganizationalUnit::EBMT(CIC)CodeNumber
Item
EBMT Code (CIC) Number
float
C0237753 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0029246 (UMLS CUI [1,4])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0029246 (UMLS CUI [1,4])
Klinik
Item
Hospital
text
C0019994 (UMLS CUI [1])
Unit
Item
Unit
text
Contact person
Item
Contact person
text
ContactPersonTelephoneNumber
Item
Phone
text
C0237753 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0039457 (UMLS CUI [1,3])
C0337611 (UMLS CUI [1,4])
C0027361 (UMLS CUI [1,2])
C0039457 (UMLS CUI [1,3])
C0337611 (UMLS CUI [1,4])
ContactPersonFaxNumber
Item
Fax
text
C0237753 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
C0085205 (UMLS CUI [1,4])
C0027361 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
C0085205 (UMLS CUI [1,4])
ContactPersonE-mailText
Item
E-mail
text
C1527021 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,3])
C0337611 (UMLS CUI [1,4])
C0027361 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,3])
C0337611 (UMLS CUI [1,4])
Date of this report
Item
Date of this report
date
C1302584 (UMLS CUI [1])
Unique Patient Number or Code
Item
Unique Patient Number or Code
text
Initialen
Item
Initials
text
C2986440 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
CL Item
male (1)
CL Item
female (2)
Diagnose-Datum
Item
Date of diagnosis
date
C2316983 (UMLS CUI [1,1])
C1274082 (UMLS CUI [1,2])
C1274082 (UMLS CUI [1,2])
Autoimmune disease, specify
Item
Autoimmune disease, specify
text
Neurologic disorder, specify
Item
Neurologic disorder, specify
text
Heart disease, specify
Item
Heart disease, specify
text
Haematologic, specify
Item
Haematologic, specify
text
Other, specify
Item
Other, specify
text
Item
If Haematopoietic stem cell transplant related
text
Code List
If Haematopoietic stem cell transplant related
CL Item
GvHD prophylaxis (1)
CL Item
GvHD treatment (2)
CL Item
Prevention of rejection (3)
CL Item
Graft enhancement (4)
CL Item
Bone marrow failure (5)
Date of first cell infusion
Item
Date of first cell infusion
date
CL Item
Karnofsky (1)
CL Item
Lansky (2)
CL Item
10 (1)
CL Item
20 (2)
CL Item
30 (3)
CL Item
40 (4)
CL Item
50 (5)
CL Item
60 (6)
CL Item
70 (7)
CL Item
80 (8)
CL Item
90 (9)
CL Item
100 (10)
CL Item
Chronic (1)
CL Item
Acute (2)
CL Item
Acute exacerbation of chronic disease (3)
CL Item
Allogeneic (1)
CL Item
Autologous (2)
CL Item
Bone Marrow VBMSC (1)
CL Item
Peripheral Blood VPBSC (2)
CL Item
Cord Blood VCBSC (3)
CL Item
Adipose ADIPCELL (4)
CL Item
Endothelial cell progenitor ENDOCELL (5)
CL Item
Other, specify (6)
Tissue cell source
Item
Tissue cell source, specify other
text
CL Item
Mononuclear cells (1)
CL Item
CD34+ CD34POS (2)
CL Item
Mesenchymal MESECHYM (3)
CL Item
Unseparated bone marrow (4)
CL Item
Other, specify (5)
Cell characteristic
Item
Cell characteristic, specify other
text
Chronological no. of cell therapy for this patient
Item
Chronological no. of cell therapy for this patient
integer
CL Item
no (1)
CL Item
yes (2)
CL Item
unknown (3)
CL Item
Growth factor, specify (4)
CL Item
Other (5)
CL Item
Expansion (6)
Ex-vivo manipulation
Item
Ex-vivo manipulation, Growth factor, specify
text
Ex-vivo manipulation
Item
Ex-vivo manipulation, other
text
CL Item
No (1)
CL Item
Yes: (2)
CL Item
Growth factor, specify (3)
CL Item
Other (4)
CL Item
unknown (5)
In-vivo manipulation In the donor
Item
In-vivo manipulation In the donor, growth factor, specify
text
In-vivo manipulation In the donor
Item
In-vivo manipulation In the donor, other
text
CL Item
No (1)
CL Item
Yes (2)
CL Item
Growth factor, specify (3)
CL Item
Other (4)
CL Item
Unknown (5)
In-vivo manipulation, in the patient
Item
In-vivo manipulation in the patient, growth factor, specify
text
In-vivo manipulation, in the patient
Item
In-vivo manipulation in the patient, other
text
CL Item
Intravenous (1)
CL Item
Locally intra-arterially, specify artery (2)
CL Item
Locally into tissue (3)
CL Item
Intra bone (4)
CL Item
Other route (5)
CL Item
Intraperiteonally (6)
CL Item
ntrathecal (7)
Route of infusion
Item
Route of infusion, Locally intra-arterially, specify artery
text
Route of infusion
Item
Route of infusion, pther route
text
CL Item
Total No of infusions (1)
CL Item
No of cells infused per infusion (2)
Dose
Item
Dose, Total No of infusions
integer
Dose
Item
Dose, No of cells infused per infusion
integer
CL Item
no (1)
CL Item
yes (2)
CL Item
Prior to cell therapy (3)
CL Item
Simultaneous (4)
CL Item
Post cell therapy (5)
CL Item
unknown (6)
Associated procedure
Item
Associated procedure, Yes: specify
text
Item
Best clinical/biological response after cell therapy
integer
Code List
Best clinical/biological response after cell therapy
CL Item
Complete sustained remission (CR) (1)
CL Item
Partial sustained remission (PR) (2)
CL Item
Remission (CR or PR) followed by relapse or progression (3)
CL Item
Stable (4)
CL Item
Progression (5)
CL Item
Unknown (6)
CL Item
Normalized (1)
CL Item
Improvement (2)
CL Item
Unchanged (3)
CL Item
Worsening (4)
CL Item
Specify laboratory parameter (5)
Laboratory response
Item
Laboratory response, Specify laboratory parameter
text
Date of last follow up or death
Item
Date of last follow up or death
date
CL Item
Alive (1)
CL Item
Dead (2)
CL Item
Check here if patient lost to follow up (3)
CL Item
Relapse or Progression (if indication: primary disease) (1)
CL Item
HSCT related (if applicable) (2)
CL Item
Cell Therapy related (3)
CL Item
Other (4)
CL Item
Unknown (5)
Main Cause of Death
Item
Main Cause of Death, HSCT related (if applicable
text
Main Cause of Death
Item
Main Cause of Death, Cell Therapy related:
text
Main Cause of Death
Item
Main Cause of Death, Other
text
OrganizationalUnit::EBMT(CIC)CodeNumber
Item
EBMT Code (CIC) Number
float
C0237753 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0029246 (UMLS CUI [1,4])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0029246 (UMLS CUI [1,4])
Hospital
Item
Hospital
text
Unit
Item
Unit
text
Contact person
Item
Contact person
text
ContactPersonTelephoneNumber
Item
Phone
text
C0237753 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0039457 (UMLS CUI [1,3])
C0337611 (UMLS CUI [1,4])
C0027361 (UMLS CUI [1,2])
C0039457 (UMLS CUI [1,3])
C0337611 (UMLS CUI [1,4])
ContactPersonFaxNumber
Item
Fax
text
C0237753 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
C0085205 (UMLS CUI [1,4])
C0027361 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
C0085205 (UMLS CUI [1,4])
CentralLaboratoryContactPersonEmailAddressText
Item
Contact Person E-Mail
text
C0027361 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
C1705961 (UMLS CUI [1,4])
C0013849 (UMLS CUI [1,5])
C0022877 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
C1705961 (UMLS CUI [1,4])
C0013849 (UMLS CUI [1,5])
Date of this Report
Item
Date of this Report
date
Unique Patient Number or Code
Item
Unique Patient Number or Code
integer
Initials
Item
Initials, first name(s), family name(s)
text
PersonBirthDate
Item
Date of Birth
date
C0011008 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0005615 (UMLS CUI [1,3])
C0027361 (UMLS CUI [1,2])
C0005615 (UMLS CUI [1,3])
CL Item
Male (1)
CL Item
Female (2)
DATE OF LAST CONTACT
Item
DATE OF LAST CONTACT
date
CL Item
no (1)
CL Item
yes (2)
CL Item
Alive (1)
CL Item
Dead (2)
CL Item
Check here if patient lost to follow up (3)
CL Item
Relapse or Progression (1)
CL Item
Relapse or Progression (2)
CL Item
Cell Therapy related (3)
CL Item
Other (4)
CL Item
Unknown (5)
Main Cause of Death
Item
Main Cause of Death, HSCT related (if applicable)
text
Main Cause of Death
Item
Main Cause of Death, Cell Therapy related
text
Main Cause of Death
Item
Main Cause of Death, Other
text