ID

12441

Description

Hyper-PEI-protocol:a programme with regional deep hyperthermia(RHT)in combination with PEI-chemotherapy.The Hyper-PEI protocol is offered in place of the intensive standard chemotherapy for high-risk patie nts with malignant, extracranial tumors. Patients have a measurable relapsed tumor,or a primary tumor that did not respond sufficiently to treatment according to standard protocols. Responsible MD: PD Dr. med. R Wessalowski, Clinic for pediatric oncology,haematology and immunology UKD, Moorenstr. 5, 40225 Dusseldorf Form has to be completed by cooperating center or clinic after inclusion and sent to the Hyper-PEI director.

Keywords

  1. 11/19/15 11/19/15 - Julian Varghese
Uploaded on

November 19, 2015

DOI

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License

Creative Commons BY-NC 3.0

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Initial Visit Hyperthermia Treatment Study

Initial Visit Hyperthermia Treatment Study

Patient Identification
Description

Patient Identification

Patient Name
Description

Patient Name

Data type

text

Alias
UMLS CUI [1]
C1299487
Inclusion confirmation
Description

Inclusion confirmation

Inclusion confirmed by Hyper-PEI leader
Description

Inclusion confirmation

Data type

boolean

Alias
UMLS CUI [1]
C1512693
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Initial Therapy
Description

Initial Therapy

Treatment Regimen
Description

Regimen

Data type

text

Alias
UMLS CUI [1]
C0949219
Start date
Description

Start date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C0808070
dd/mm/yy
End date
Description

End date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C0806020
dd/mm/yy
Radiotherapy
Description

Radiotherapy

Data type

text

Alias
UMLS CUI [1]
C1522449
Surgery
Description

surgery

Data type

text

Alias
UMLS CUI [1]
C0543467
Response
Description

Response

Complete remission (CR)
Description

complete remission

Data type

text

Alias
UMLS CUI [1]
C0677874
Partial Response (PR)
Description

tumor reduced by no less than 50%

Data type

text

Alias
UMLS CUI [1]
C1521726
Low Response
Description

tumor reduced by no less than 25 percent up to 50 percent

Data type

text

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C0205251
Stable Disease
Description

tumor reduced less than 25 percent or increased less than 25 percent

Data type

text

Alias
UMLS CUI [1]
C0677946
Progression
Description

Tumor increased by at least 25 percent

Data type

text

Alias
UMLS CUI [1]
C0242656
Progression Treatment
Description

Progression Treatment

Treatment Regimen
Description

Regimen

Data type

text

Alias
UMLS CUI [1]
C0949219
Start date
Description

Start date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C0808070
dd/mm/yy
End date
Description

End date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C0806020
dd/mm/yy
Radiotherapy
Description

Radiotherapy

Data type

text

Alias
UMLS CUI [1]
C1522449
Surgery
Description

surgery

Data type

text

Alias
UMLS CUI [1]
C0038895
Response
Description

Response

Complete remission (CR)
Description

Remission

Data type

text

Alias
UMLS CUI [1]
C0544452
Partial Response
Description

tumor reduced by no less than 50 percent

Data type

text

Alias
UMLS CUI [1]
C1521726
Low Response
Description

tumor reduced by no less than 25 percent up to 50 percent

Data type

text

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C0205251
Stable Disease
Description

tumor reduced less than 25 percent or increased less than 25 percent

Data type

text

Alias
UMLS CUI [1]
C0677946
Progression
Description

Tumor increased by at least 25 percent

Data type

text

Alias
UMLS CUI [1]
C0242656
Diagnostic Radiology
Description

Diagnostic Radiology

Localisation
Description

2- dimensional measurement of tumor before treatment

Data type

text

Alias
UMLS CUI [1,1]
C0475264
UMLS CUI [1,2]
C0027651
Dimension 1
Description

TumorLargestDimensionMeasurement

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0027651
cm
Dimension 2
Description

TumorSecondDimensionMeasurement

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0027651
cm
Measurement Method
Description

Measurement Method

Data type

text

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0449851
Is there evidence of metastasis
Description

Localisation of metastasis

Data type

text

Alias
UMLS CUI [1,1]
C2939420
UMLS CUI [1,2]
C1515974
Dimension 1
Description

MetastasisLargestDimensionMeasurement

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0027651
cm
Dimension 2
Description

MetastasisSecondDimensionMeasurement

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0027651
cm
Measurement Method
Description

Measurement Method

Data type

text

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0449851
Patient History
Description

Patient History

Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Has the childhood development been normal before diagnose
Description

Child Development

Data type

text

Alias
UMLS CUI [1]
C0008071
Body Height
Description

Height

Data type

text

Alias
UMLS CUI [1]
C0005890
Development of Weight
Description

weight

Data type

text

Alias
UMLS CUI [1]
C0043100
Psychomotor Development
Description

Psychomotor Development

Data type

text

Alias
UMLS CUI [1]
C0392358
Sexual Development
Description

sexual Development

Data type

text

Alias
UMLS CUI [1]
C0233896
History of childhood diseases
Description

Childhood diseases

Data type

text

Alias
UMLS CUI [1]
C0489532
Rubeola
Description

rubeola

Data type

text

Alias
UMLS CUI [1]
C0035920
Measles
Description

measles

Data type

text

Alias
UMLS CUI [1]
C0025007
Mumps
Description

Mumps

Data type

text

Alias
UMLS CUI [1]
C0026780
Pertussis
Description

Pertussis

Data type

text

Alias
UMLS CUI [1]
C0043167
TBC
Description

Tuberculosis

Data type

text

Alias
UMLS CUI [1]
C0041296
scarlet fever
Description

scarlet fever

Data type

text

Alias
UMLS CUI [1]
C0036285
Chickenpox
Description

Chickenpox

Data type

text

Alias
UMLS CUI [1]
C0008049
Any current side effects of tumor treatment
Description

Side effects

Data type

text

Alias
UMLS CUI [1]
C0041755
If yes, please specify
Description

Side effects

Data type

text

Alias
UMLS CUI [1]
C0041755
Other relevant diseases
Description

Other relevant diseases

Data type

text

Alias
UMLS CUI [1]
C0012634
If yes, please specify
Description

Other relevant diseases

Data type

text

Alias
UMLS CUI [1]
C0012634
operative procedures other than tumor surgery
Description

surgery

Data type

text

Alias
UMLS CUI [1]
C0038895
If yes, please specify
Description

surgery

Data type

text

Alias
UMLS CUI [1]
C0038895
Vaccinations
Description

Vaccinations

Measles
Description

Measles

Data type

text

Alias
UMLS CUI [1]
C0025007
Mumps
Description

Mumps

Data type

text

Alias
UMLS CUI [1]
C0026780
Rubeola
Description

Rubeola

Data type

text

Alias
UMLS CUI [1]
C0035920
Pertussis
Description

Pertussis

Data type

text

Alias
UMLS CUI [1]
C0043167
Tuberculosis
Description

Tuberculosis

Data type

text

Alias
UMLS CUI [1]
C0041296
Polio
Description

Poliomyelitis

Data type

text

Alias
UMLS CUI [1]
C0032371
Diphteria
Description

Diphtheria

Data type

text

Alias
UMLS CUI [1]
C0012546
Tetanus
Description

Tetanus

Data type

text

Alias
UMLS CUI [1]
C0199807
HIB
Description

Hemophilus influenzae B

Data type

text

Alias
UMLS CUI [1]
C3653328
Type B viral hepatitis
Description

Hepatitis B

Data type

text

Alias
UMLS CUI [1]
C0019163
Virological Diagnostics
Description

Virological Diagnostics

Findings should be enclosed, no older than 4 weeks
Description

Findings

Data type

text

Alias
UMLS CUI [1]
C0243095
Human immunodeficiency virus
Description

HIV

Data type

text

Alias
UMLS CUI [1]
C0019682
Type B viral hepatitis
Description

Hepatitis B

Data type

text

Alias
UMLS CUI [1]
C0019163
Viral hepatitis C
Description

Hepatitis C

Data type

text

Alias
UMLS CUI [1]
C0019196
HSV IgG
Description

serology and PCR

Data type

text

Alias
UMLS CUI [1]
C0206558
CMV
Description

serology and PCR

Data type

integer

Alias
UMLS CUI [1]
C0010825
EBV status
Description

serology and PCR

Data type

text

Alias
UMLS CUI [1]
C0014644
HHV6
Description

HHV6

Data type

text

Alias
UMLS CUI [1]
C0019381
VZV
Description

serology and PCR

Data type

text

Alias
UMLS CUI [1]
C0042338
Adenovirus
Description

Adenoviruses

Data type

text

Alias
UMLS CUI [1]
C0001483
Parvovirus B 19
Description

Parvovirus B 19

Data type

text

Alias
UMLS CUI [1]
C0085274
Microbiological Diagnostics
Description

Microbiological Diagnostics

Findings should be enclosed, no older than 4 weeks
Description

Findings

Data type

text

Alias
UMLS CUI [1]
C0243095
Toxoplasma Antibodies
Description

Toxoplasma

Data type

text

Alias
UMLS CUI [1]
C0370073
Mycoplasma Antibodies
Description

Mycoplasma

Data type

text

Alias
UMLS CUI [1]
C0443703
Syphilis Antibodies
Description

Syphilis Antibodies

Data type

text

Alias
UMLS CUI [1]
C0474646
Confirmation of correctness
Description

Confirmation of correctness

Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Treating Physician
Description

Physician

Data type

text

Alias
UMLS CUI [1]
C1710470
Signature
Description

Responsible Person Signature

Data type

text

Alias
UMLS CUI [1]
C1550483

Similar models

Initial Visit Hyperthermia Treatment Study

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Identification
Patient Name
Item
Patient Name
text
C1299487 (UMLS CUI [1])
Item Group
Inclusion confirmation
Inclusion confirmation
Item
Inclusion confirmed by Hyper-PEI leader
boolean
C1512693 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Initial Therapy
Regimen
Item
Treatment Regimen
text
C0949219 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Item
Radiotherapy
text
C1522449 (UMLS CUI [1])
Code List
Radiotherapy
CL Item
yes no=no not known=not known (yes)
Item
Surgery
text
C0543467 (UMLS CUI [1])
Code List
Surgery
CL Item
yes no=no not known=not known (yes)
Item Group
Response
Item
Complete remission (CR)
text
C0677874 (UMLS CUI [1])
Code List
Complete remission (CR)
CL Item
yes no=no not known=not known (yes)
Item
Partial Response (PR)
text
C1521726 (UMLS CUI [1])
Code List
Partial Response (PR)
CL Item
yes no=no not known=not known (yes)
Item
Low Response
text
C1704632 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Code List
Low Response
CL Item
yes no=no not known=not known (yes)
Item
Stable Disease
text
C0677946 (UMLS CUI [1])
Code List
Stable Disease
CL Item
yes no=no not known=not known (yes)
Item
Progression
text
C0242656 (UMLS CUI [1])
Code List
Progression
CL Item
yes no=no not known=not known (yes)
Item Group
Progression Treatment
Regimen
Item
Treatment Regimen
text
C0949219 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Item
Radiotherapy
text
C1522449 (UMLS CUI [1])
Code List
Radiotherapy
CL Item
yes no=no not known=not known (yes)
Item
Surgery
text
C0038895 (UMLS CUI [1])
Code List
Surgery
CL Item
yes no=no not known=not known (yes)
Item Group
Response
Item
Complete remission (CR)
text
C0544452 (UMLS CUI [1])
Code List
Complete remission (CR)
CL Item
yes no=no not known=not known (yes)
Item
Partial Response
text
C1521726 (UMLS CUI [1])
Code List
Partial Response
CL Item
yes no=no not known=not known (yes)
Item
Low Response
text
C1704632 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Code List
Low Response
CL Item
yes no=no not known=not known (yes)
Item
Stable Disease
text
C0677946 (UMLS CUI [1])
Code List
Stable Disease
CL Item
yes no=no not known=not known (yes)
Item
Progression
text
C0242656 (UMLS CUI [1])
Code List
Progression
CL Item
yes no=no not known=not known (yes)
Item Group
Diagnostic Radiology
Localisation
Item
Localisation
text
C0475264 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
TumorLargestDimensionMeasurement
Item
Dimension 1
float
C0242485 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
TumorSecondDimensionMeasurement
Item
Dimension 2
float
C0242485 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
Item
Measurement Method
text
C0242485 (UMLS CUI [1,1])
C0449851 (UMLS CUI [1,2])
Code List
Measurement Method
CL Item
x-ray, 2=CT, 3=MRI, 4=Ultrasound (1)
Item
Is there evidence of metastasis
text
C2939420 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Code List
Is there evidence of metastasis
CL Item
yes , no=no , not known=not known (yes)
MetastasisLargestDimensionMeasurement
Item
Dimension 1
float
C0242485 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
MetastasisSecondDimensionMeasurement
Item
Dimension 2
float
C0242485 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
Item
Measurement Method
text
C0242485 (UMLS CUI [1,1])
C0449851 (UMLS CUI [1,2])
Code List
Measurement Method
CL Item
X-ray , 2=CT , 3=MRI , 4=Ultrasound (1)
Item Group
Patient History
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Child Development
Item
Has the childhood development been normal before diagnose
text
C0008071 (UMLS CUI [1])
Item
Body Height
text
C0005890 (UMLS CUI [1])
Code List
Body Height
CL Item
yes , no=no , not know=not known (yes)
Item
Development of Weight
text
C0043100 (UMLS CUI [1])
Code List
Development of Weight
CL Item
yes , no=no , not known=not known (yes)
Item
Psychomotor Development
text
C0392358 (UMLS CUI [1])
Code List
Psychomotor Development
CL Item
yes , no=no , not known=not known (yes)
Item
Sexual Development
text
C0233896 (UMLS CUI [1])
Code List
Sexual Development
CL Item
yes , no=no , not known=not known (yes)
Childhood diseases
Item
History of childhood diseases
text
C0489532 (UMLS CUI [1])
Item
Rubeola
text
C0035920 (UMLS CUI [1])
Code List
Rubeola
CL Item
yes , no=no, not known=not known (yes)
Item
Measles
text
C0025007 (UMLS CUI [1])
Code List
Measles
CL Item
yes , no=no , not know=not known (yes)
Item
Mumps
text
C0026780 (UMLS CUI [1])
Code List
Mumps
CL Item
yes , no=no , not known=not known (yes)
Item
Pertussis
text
C0043167 (UMLS CUI [1])
Code List
Pertussis
CL Item
yes , no=no , not known=not known (yes)
Item
TBC
text
C0041296 (UMLS CUI [1])
Code List
TBC
CL Item
yes , no=no , not known=not known (yes)
Item
scarlet fever
text
C0036285 (UMLS CUI [1])
Code List
scarlet fever
CL Item
yes , no=no , not known=not known (yes)
Item
Chickenpox
text
C0008049 (UMLS CUI [1])
Code List
Chickenpox
CL Item
yes , no=no , not known=not known (yes)
Item
Any current side effects of tumor treatment
text
C0041755 (UMLS CUI [1])
Code List
Any current side effects of tumor treatment
CL Item
yes , no=no, not known=not known (yes)
Side effects
Item
If yes, please specify
text
C0041755 (UMLS CUI [1])
Item
Other relevant diseases
text
C0012634 (UMLS CUI [1])
CL Item
yes , no=no, not known=not known (yes)
Other relevant diseases
Item
If yes, please specify
text
C0012634 (UMLS CUI [1])
Item
operative procedures other than tumor surgery
text
C0038895 (UMLS CUI [1])
Code List
operative procedures other than tumor surgery
CL Item
yes , no=no, not known=not known (yes)
surgery
Item
If yes, please specify
text
C0038895 (UMLS CUI [1])
Item Group
Vaccinations
Item
Measles
text
C0025007 (UMLS CUI [1])
Code List
Measles
CL Item
yes , no=no , not known=not known (yes)
Item
Mumps
text
C0026780 (UMLS CUI [1])
Code List
Mumps
CL Item
yes , no=no , not known=not known (yes)
Item
Rubeola
text
C0035920 (UMLS CUI [1])
Code List
Rubeola
CL Item
yes , no=no, not known=not known (yes)
Item
Pertussis
text
C0043167 (UMLS CUI [1])
Code List
Pertussis
CL Item
yes , no=no, not known=not known (yes)
Item
Tuberculosis
text
C0041296 (UMLS CUI [1])
Code List
Tuberculosis
CL Item
yes , no=no, not known=not known (yes)
Item
Polio
text
C0032371 (UMLS CUI [1])
Code List
Polio
CL Item
yes , no=no, not known=not known (yes)
Item
Diphteria
text
C0012546 (UMLS CUI [1])
Code List
Diphteria
CL Item
yes , no=no, not known=not known (yes)
Item
Tetanus
text
C0199807 (UMLS CUI [1])
Code List
Tetanus
CL Item
yes , no=no, not known=not known (yes)
Item
HIB
text
C3653328 (UMLS CUI [1])
CL Item
yes , no=no, not known=not known (yes)
Item
Type B viral hepatitis
text
C0019163 (UMLS CUI [1])
Code List
Type B viral hepatitis
CL Item
yes , no=no, not known=not known (yes)
Item Group
Virological Diagnostics
Findings
Item
Findings should be enclosed, no older than 4 weeks
text
C0243095 (UMLS CUI [1])
Item
Human immunodeficiency virus
text
C0019682 (UMLS CUI [1])
Code List
Human immunodeficiency virus
CL Item
infection (1)
CL Item
immunity (2)
CL Item
negative (3)
CL Item
not known (4)
Item
Type B viral hepatitis
text
C0019163 (UMLS CUI [1])
Code List
Type B viral hepatitis
CL Item
infection 2= immunity 3= negative 4= not known (1)
Item
Viral hepatitis C
text
C0019196 (UMLS CUI [1])
Code List
Viral hepatitis C
CL Item
infection 2= immunity 3= negative 4= not known (1)
Item
HSV IgG
text
C0206558 (UMLS CUI [1])
Code List
HSV IgG
CL Item
infection 2= immunity 3= negative 4= not known (1)
Item
CMV
integer
C0010825 (UMLS CUI [1])
Code List
CMV
CL Item
infection 2= immunity 3= negative 4= not known (1)
Item
EBV status
text
C0014644 (UMLS CUI [1])
Code List
EBV status
CL Item
infection 2= immunity 3= negative 4= not known (1)
Item
HHV6
text
C0019381 (UMLS CUI [1])
Code List
HHV6
CL Item
infection 2= immunity 3= negative 4= not known (1)
Item
VZV
text
C0042338 (UMLS CUI [1])
Code List
VZV
CL Item
infection 2= immunity 3= negative 4= not known (1)
Item
Adenovirus
text
C0001483 (UMLS CUI [1])
Code List
Adenovirus
CL Item
infection 2= immunity 3= negative 4= not known (1)
Item
Parvovirus B 19
text
C0085274 (UMLS CUI [1])
Code List
Parvovirus B 19
CL Item
infection 2= immunity 3= negative 4= not known (1)
Item Group
Microbiological Diagnostics
Findings
Item
Findings should be enclosed, no older than 4 weeks
text
C0243095 (UMLS CUI [1])
Item
Toxoplasma Antibodies
text
C0370073 (UMLS CUI [1])
Code List
Toxoplasma Antibodies
CL Item
infection 2= immunity 3= negative 4= not known (1)
Item
Mycoplasma Antibodies
text
C0443703 (UMLS CUI [1])
Code List
Mycoplasma Antibodies
CL Item
infection 2= immunity 3= negative 4= not known (1)
Item
Syphilis Antibodies
text
C0474646 (UMLS CUI [1])
Code List
Syphilis Antibodies
CL Item
infection 2= immunity 3= negative 4= not known (1)
Item Group
Confirmation of correctness
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Physician
Item
Treating Physician
text
C1710470 (UMLS CUI [1])
Responsible Person Signature
Item
Signature
text
C1550483 (UMLS CUI [1])

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