ID

12427

Beskrivning

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.

Nyckelord

Versioner (2)
  1. 2015-11-17 2015-11-17 - Julian Varghese
  2. 2015-11-17 2015-11-17 - Julian Varghese
Uppladdad den

17 november 2015

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0 Legacy
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Admission and Eligiblity Form Hyperthermia Treatment Study

Engelsk

Admission and Eligibility

1 Formulär  
Patient Identification
Beskrivning

Patient Identification

Alias
UMLS CUI-1
C1269815
Patient Name
Beskrivning

Patient Name

Datatyp

text

Alias
UMLS CUI [1]
C1299487
Date
Beskrivning

Date

Alias
UMLS CUI-1
C0011008
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Inclusion criteria
Beskrivning

Inclusion criteria

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

Histologically significant solid tumor

Datatyp

boolean

Alias
UMLS CUI [1]
C1698088
No metastases
Beskrivning

no metastases

Datatyp

boolean

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

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

Datatyp

boolean

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

Staging

Datatyp

boolean

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

Other study

Datatyp

boolean

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

age

Datatyp

boolean

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

Informed consent

Datatyp

boolean

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

Lansky/Karnovsky score

Datatyp

boolean

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

Life expectancy

Datatyp

boolean

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

hemoglobin

Datatyp

boolean

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

Platelets

Datatyp

boolean

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

Creatinine

Datatyp

boolean

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

Creatinine clearance

Datatyp

boolean

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

Transaminases

Datatyp

boolean

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

Bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
Normal coagulation
Beskrivning

Coagulation

Datatyp

boolean

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

Leukapheresis

Datatyp

boolean

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

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Exclusion criteria
Beskrivning

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Cardiac pacemaker
Beskrivning

Pacemaker

Datatyp

boolean

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

if need be consult with study coordinator

Datatyp

boolean

Alias
UMLS CUI [1]
C0021102
Metastatic malignant disease
Beskrivning

Metastasis

Datatyp

boolean

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

Pregnancy

Datatyp

boolean

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

Hepatitis B or C infection

Datatyp

boolean

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

HIV

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
Comment
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Attachment
Beskrivning

Attachment

Alias
UMLS CUI-1
C1999228
Diagnostic Imaging of staging
Beskrivning

x-Ray, Ultrasound, CT, MRI

Datatyp

boolean

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

Correctness of information confirmed

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

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Responsible physician
Beskrivning

physician

Datatyp

text

Alias
UMLS CUI [1]
C1710470
Signature
Beskrivning

Responsible Person Signature

Datatyp

text

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

Inclusion of Patient into Hyper-PEI Protocol

Alias
UMLS CUI-1
C1512693
Date
Beskrivning

Date

Datatyp

date

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

Signature

Datatyp

text

Alias
UMLS CUI [1]
C0807938
Tillbaka till toppen

Similar models

Admission and Eligibility

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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