ID

12427

Descripción

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.

Palabras clave

Versiones (2)
  1. 17/11/15 17/11/15 - Julian Varghese
  2. 17/11/15 17/11/15 - Julian Varghese
Subido en

17 de noviembre de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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Admission and Eligiblity Form Hyperthermia Treatment Study

Inglés

Admission and Eligibility

1 formularios  
Patient Identification
Descripción

Patient Identification

Alias
UMLS CUI-1
C1269815
Patient Name
Descripción

Patient Name

Tipo de datos

text

Alias
UMLS CUI [1]
C1299487
Date
Descripción

Date

Alias
UMLS CUI-1
C0011008
Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Inclusion criteria
Descripción

Inclusion criteria

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

Histologically significant solid tumor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1698088
No metastases
Descripción

no metastases

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

Staging

Tipo de datos

boolean

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

Other study

Tipo de datos

boolean

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

age

Tipo de datos

boolean

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

Informed consent

Tipo de datos

boolean

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

Lansky/Karnovsky score

Tipo de datos

boolean

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

Life expectancy

Tipo de datos

boolean

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

hemoglobin

Tipo de datos

boolean

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

Platelets

Tipo de datos

boolean

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

Creatinine

Tipo de datos

boolean

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

Creatinine clearance

Tipo de datos

boolean

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

Transaminases

Tipo de datos

boolean

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

Bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
Normal coagulation
Descripción

Coagulation

Tipo de datos

boolean

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

Leukapheresis

Tipo de datos

boolean

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

Comments

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Exclusion criteria
Descripción

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Cardiac pacemaker
Descripción

Pacemaker

Tipo de datos

boolean

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

if need be consult with study coordinator

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021102
Metastatic malignant disease
Descripción

Metastasis

Tipo de datos

boolean

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

Pregnancy

Tipo de datos

boolean

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

Hepatitis B or C infection

Tipo de datos

boolean

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

HIV

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
Comment
Descripción

Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Attachment
Descripción

Attachment

Alias
UMLS CUI-1
C1999228
Diagnostic Imaging of staging
Descripción

x-Ray, Ultrasound, CT, MRI

Tipo de datos

boolean

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

Correctness of information confirmed

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

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Responsible physician
Descripción

physician

Tipo de datos

text

Alias
UMLS CUI [1]
C1710470
Signature
Descripción

Responsible Person Signature

Tipo de datos

text

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

Inclusion of Patient into Hyper-PEI Protocol

Alias
UMLS CUI-1
C1512693
Date
Descripción

Date

Tipo de datos

date

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

Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C0807938
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Similar models

Admission and Eligibility

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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