ID

12427

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 and sent to the Hyper-PEI director. Confirmation or denial of admittance will be sent to the cooperating center and GPOH study coordinator by head of protocol.

Keywords

Versions (2)
  1. 11/17/15 11/17/15 - Julian Varghese
  2. 11/17/15 11/17/15 - Julian Varghese
Uploaded on

November 17, 2015

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Admission and Eligiblity Form Hyperthermia Treatment Study

English

Admission and Eligibility

1 forms  
Patient Identification
Description

Patient Identification

Alias
UMLS CUI-1
C1269815
Patient Name
Description

Patient Name

Data type

text

Alias
UMLS CUI [1]
C1299487
Date
Description

Date

Alias
UMLS CUI-1
C0011008
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI-1
C1512693
Histologically significant malignant solid extracerebral and extrapulmonary tumor
Description

Histologically significant solid tumor

Data type

boolean

Alias
UMLS CUI [1]
C1698088
No metastases
Description

no metastases

Data type

boolean

Alias
UMLS CUI [1]
C0445092
Documented evidence of metastatic disease
Description

Only if prognosis of patient can be improved significantly through treatment of tumor-section

Data type

boolean

Alias
UMLS CUI [1]
C0027627
Recent, complete Staging
Description

Staging

Data type

boolean

Alias
UMLS CUI [1]
C1515169
No participiation in any other experimental studies within past 4 weeks
Description

Other study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Age ≥ 25 years at time of diagnosis
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Informed Consent given and signed
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Lansky/Karnovsky score ≥70
Description

Lansky/Karnovsky score

Data type

boolean

Alias
UMLS CUI [1]
C1522275
Life expectancy ≥ 3 months
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Blood count Hb 8 g/dl (or transfusion)
Description

hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0019046
Platelets count must be ≥ 50.000 (or transfusion)
Description

Platelets

Data type

boolean

Alias
UMLS CUI [1]
C0005821
Creatinine no greater than 1,5 times ULN
Description

Creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
Creatinine clearance > 50 mml/min/1.73m2
Description

Creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
Transaminases < 2 times ULN
Description

Transaminases

Data type

boolean

Alias
UMLS CUI [1]
C0002594
Bilirubin total <1,5 mg/dl
Description

Bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
Normal coagulation
Description

Coagulation

Data type

boolean

Alias
UMLS CUI [1]
C0005778
Leukapheresis or bone marrow aspiration possible
Description

Leukapheresis

Data type

boolean

Alias
UMLS CUI [1]
C0023416
UMLS CUI [2]
C0398523
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Cardiac pacemaker
Description

Pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C0030163
Implant or other metallic device in area of hyperthermia
Description

if need be consult with study coordinator

Data type

boolean

Alias
UMLS CUI [1]
C0021102
Metastatic malignant disease
Description

Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
Currently Pregnant or breast feeding
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Hepatitis B/C infection
Description

Hepatitis B or C infection

Data type

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C0019163
HIV positivity
Description

HIV

Data type

boolean

Alias
UMLS CUI [1]
C0019699
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Attachment
Description

Attachment

Alias
UMLS CUI-1
C1999228
Diagnostic Imaging of staging
Description

x-Ray, Ultrasound, CT, MRI

Data type

boolean

Alias
UMLS CUI [1]
C0011923
Correctness of information confirmed
Description

Correctness of information confirmed

Alias
UMLS CUI-1
C0521091
UMLS CUI-2
C1533716
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Responsible physician
Description

physician

Data type

text

Alias
UMLS CUI [1]
C1710470
Signature
Description

Responsible Person Signature

Data type

text

Alias
UMLS CUI [1]
C1550483
Inclusion of Patient into Hyper-PEI Protocol
Description

Inclusion of Patient into Hyper-PEI Protocol

Alias
UMLS CUI-1
C1512693
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature Head of Hyper-PEI Dusseldorf
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C0807938
Back to the top of the page

Similar models

Admission and Eligibility

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Identification
C1269815 (UMLS CUI-1)
Patient Name
Item
Patient Name
text
C1299487 (UMLS CUI [1])
Item Group
Date
C0011008 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
Histologically significant solid tumor
Item
Histologically significant malignant solid extracerebral and extrapulmonary tumor
boolean
C1698088 (UMLS CUI [1])
no metastases
Item
No metastases
boolean
C0445092 (UMLS CUI [1])
Metastasis
Item
Documented evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1])
Staging
Item
Recent, complete Staging
boolean
C1515169 (UMLS CUI [1])
Other study
Item
No participiation in any other experimental studies within past 4 weeks
boolean
C2348568 (UMLS CUI [1])
age
Item
Age ≥ 25 years at time of diagnosis
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
Informed Consent given and signed
boolean
C0021430 (UMLS CUI [1])
Lansky/Karnovsky score
Item
Lansky/Karnovsky score ≥70
boolean
C1522275 (UMLS CUI [1])
Life expectancy
Item
Life expectancy ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
hemoglobin
Item
Blood count Hb 8 g/dl (or transfusion)
boolean
C0019046 (UMLS CUI [1])
Platelets
Item
Platelets count must be ≥ 50.000 (or transfusion)
boolean
C0005821 (UMLS CUI [1])
Creatinine
Item
Creatinine no greater than 1,5 times ULN
boolean
C0201976 (UMLS CUI [1])
Creatinine clearance
Item
Creatinine clearance > 50 mml/min/1.73m2
boolean
C0373595 (UMLS CUI [1])
Transaminases
Item
Transaminases < 2 times ULN
boolean
C0002594 (UMLS CUI [1])
Bilirubin
Item
Bilirubin total <1,5 mg/dl
boolean
C1278039 (UMLS CUI [1])
Coagulation
Item
Normal coagulation
boolean
C0005778 (UMLS CUI [1])
Leukapheresis
Item
Leukapheresis or bone marrow aspiration possible
boolean
C0023416 (UMLS CUI [1])
C0398523 (UMLS CUI [2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Pacemaker
Item
Cardiac pacemaker
boolean
C0030163 (UMLS CUI [1])
Implant
Item
Implant or other metallic device in area of hyperthermia
boolean
C0021102 (UMLS CUI [1])
Metastasis
Item
Metastatic malignant disease
boolean
C0027627 (UMLS CUI [1])
Pregnancy
Item
Currently Pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis B or C infection
Item
Hepatitis B/C infection
boolean
C0019196 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
HIV
Item
HIV positivity
boolean
C0019699 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Attachment
C1999228 (UMLS CUI-1)
Imaging
Item
Diagnostic Imaging of staging
boolean
C0011923 (UMLS CUI [1])
Item Group
Correctness of information confirmed
C0521091 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
physician
Item
Responsible physician
text
C1710470 (UMLS CUI [1])
Responsible Person Signature
Item
Signature
text
C1550483 (UMLS CUI [1])
Item Group
Inclusion of Patient into Hyper-PEI Protocol
C1512693 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature Head of Hyper-PEI Dusseldorf
text
C0807938 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial