ID

22040

Description

HD16 NCT Nr.: NCT00736320 HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET. This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS). HD17 NCT Nr.: NCT01356680 HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma.This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS). HD18 NCT Nr.: NCT00515554 HD18 for Advanced Stages in Hodgkins Lymphoma. This study is designed to test: in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles) for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS. Permission granted by: Andreas Engert, M.D. Chairman, German Hodgkin Study Group Professor for Internal Medicine Hematology & Oncology University Hospital of Cologne Department of Internal Medicine I Kerpener Str. 62 D-50924 Köln Phone: +49-221-478-5933/5966 Fax: +49-221-478-3778 a.engert@uni-koeln.de

Keywords

Versions (2)
  1. 5/16/17 5/16/17 -
  2. 11/1/18 11/1/18 - Sarah Riepenhausen
Uploaded on

May 16, 2017

DOI

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License

Creative Commons BY-NC 3.0
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German Hodgkin Study Group Study HD16/HD17/HD18 Anamnesis Report G6AN DRKS00003455 DRKS00003457

German

Deutsche Hodgkin Studiengruppe: G6AN Anamnesebogen

1 forms  
Formularkopf
Description

Formularkopf

Alias
UMLS CUI-1
C0600661
Stempel des einsendenden Instituts
Description

Stamp of participating institution

Data type

text

Alias
UMLS CUI [1]
C2347449
Telefonnummer des einsendenden Instituts (bitte mit Durchwahl)
Description

Phone number of participating institution

Data type

integer

Alias
UMLS CUI [1,1]
C2347449
UMLS CUI [1,2]
C1515258
Adresse der verantwortlichen Studienzentrale
Description

Address of responsible study center

Data type

text

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1442065
Patientenname
Description

Patient Name

Data type

text

Alias
UMLS CUI [1]
C1299487
Geburtsname
Description

Patient birth name

Data type

text

Alias
UMLS CUI [1]
C1549652
Geburtsdatum
Description

Birth Date

Data type

date

Alias
UMLS CUI [1]
C0421451
Adresse des Patienten
Description

Patient address

Data type

text

Alias
UMLS CUI [1]
C0421449
Datum des Stagingabschlusses
Description

Staging date

Data type

date

Alias
UMLS CUI [1,1]
C0027646
UMLS CUI [1,2]
C0011008
Studien ID
Description

Study ID

Data type

integer

Alias
UMLS CUI [1]
C2826693
Bogen ID
Description

CRF Indentificator

Data type

integer

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C0600091
Case ID
Description

Case ID

Data type

integer

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
Beschwerden des Patienten
Description

Beschwerden des Patienten

Alias
UMLS CUI-1
C3469071
B-Symptomatik
Description

B-Symptoms

Data type

text

Alias
UMLS CUI [1]
C1706867
Gewichtsabnahme > 10%/6 Monaten
Description

Weight loss

Data type

boolean

Alias
UMLS CUI [1]
C0936227
Unklares Fieber > 38°C
Description

Fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Nachtschweiß
Description

Night sweats

Data type

boolean

Alias
UMLS CUI [1]
C0028081
Übrige
Description

Other symptoms

Data type

text

Alias
UMLS CUI [1]
C0029625
Juckreiz
Description

Pruritus

Data type

boolean

Alias
UMLS CUI [1]
C0033774
Alkoholschmerz
Description

Alcohol-induced pain

Data type

boolean

Alias
UMLS CUI [1]
C1277603
Laborwerte
Description

Laborwerte

Alias
UMLS CUI-1
C0022877
BSG
Description

ESR

Data type

integer

Measurement units
  • mm/h
Alias
UMLS CUI [1]
C1176468
mm/h
Leukozyten
Description

WBC

Data type

float

Measurement units
  • x10^3/µl
Alias
UMLS CUI [1]
C0023508
x10^3/µl
Lymphozyten
Description

Lymphocytes

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0200635
%
Thrombozyten
Description

Platelets

Data type

integer

Measurement units
  • x10^3/µl
Alias
UMLS CUI [1]
C0005821
x10^3/µl
Erythrozyten
Description

Erythrocytes

Data type

float

Measurement units
  • x10^6/µl
Alias
UMLS CUI [1]
C0362910
x10^6/µl
Hb
Description

Hb

Data type

float

Measurement units
  • g/dl
Alias
UMLS CUI [1]
C0518015
g/dl
Hb-Wert
Description

Hb

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0518015
mmol/l
Albumin
Description

Albumin

Data type

float

Measurement units
  • g/dl
Alias
UMLS CUI [1]
C0201838
g/dl
Gesamteiweiß
Description

falls Albumin absolut nicht erhoben

Data type

float

Measurement units
  • g/dl
Alias
UMLS CUI [1]
C0555903
g/dl
Albumin
Description

Falls Albumin absolut nicht erhoben

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0201838
%
Kreatinine Clearance < 60ml/min
Description

Creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
Aktivitätsindex (nach WHO)
Description

Aktivitätsindex (nach WHO)

Alias
UMLS CUI-1
C1298651
Aktivitätsindex (nach WHO)
Description

WHO Performance status

Data type

integer

Alias
UMLS CUI [1]
C1298650
Körpergewicht
Description

Body weight

Data type

integer

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Körpergröße
Description

Body Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Körperoberfläche
Description

Body surface

Data type

float

Measurement units
  • m2
Alias
UMLS CUI [1]
C0005902
m2
Begleiterkrankungen
Description

Begleiterkrankungen

Alias
UMLS CUI-1
C0150941
Liegt eine Begleiterkrankung vor, die nicht als Ausschlußkriterium (s.E/A-Bogen) zu bewerten ist?
Description

Concomitant diseases that are not in exclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0150941
UMLS CUI [1,2]
C0680251
Welche Begleiterkrankung?
Description

Concomitant diseases

Data type

text

Alias
UMLS CUI [1]
C0150941
Hatte der Patient eine infektiöse Mononukleose?
Description

Infectious mononucleosis

Data type

integer

Alias
UMLS CUI [1]
C0021345
Familienanamnese
Description

Familienanamnese

Alias
UMLS CUI-1
C0241889
UMLS CUI-2
C0262926
Traten in der Familie bereits maligne oder nicht maligne hämatologische Erkrankungen auf?
Description

Malignant or benign hematological diseases within the family

Data type

integer

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C0205282
UMLS CUI [2,1]
C0018939
UMLS CUI [2,2]
C0205183
HL
Description

Hodgkin Lymphoma

Data type

integer

Alias
UMLS CUI [1]
C0019829
NHL
Description

Non Hodgkin Lymphoma

Data type

integer

Alias
UMLS CUI [1]
C0024305
CML
Description

CML

Data type

integer

Alias
UMLS CUI [1]
C0023473
CLL
Description

CLL

Data type

integer

Alias
UMLS CUI [1]
C0023434
AML
Description

AML

Data type

integer

Alias
UMLS CUI [1]
C0023467
ALL
Description

ALL

Data type

integer

Alias
UMLS CUI [1]
C0023449
Multiples Myelom
Description

Multiple Myeloma

Data type

integer

Alias
UMLS CUI [1]
C0026764
Multiple Sklerose
Description

Multiple Sclerosis

Data type

integer

Alias
UMLS CUI [1]
C0026769
Sarkoidose
Description

Sarcoidosis

Data type

integer

Alias
UMLS CUI [1]
C0036202
Bemerkungen
Description

Bemerkungen

Alias
UMLS CUI-1
C0947611
Datum
Description

Date of completion

Data type

date

Alias
UMLS CUI [1]
C0011008
Unterschrift
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
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Similar models

Deutsche Hodgkin Studiengruppe: G6AN Anamnesebogen

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Formularkopf
C0600661 (UMLS CUI-1)
Stamp of participating institution
Item
Stempel des einsendenden Instituts
text
C2347449 (UMLS CUI [1])
Phone number of participating institution
Item
Telefonnummer des einsendenden Instituts (bitte mit Durchwahl)
integer
C2347449 (UMLS CUI [1,1])
C1515258 (UMLS CUI [1,2])
Address of responsible study center
Item
Adresse der verantwortlichen Studienzentrale
text
C2825181 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
Patient Name
Item
Patientenname
text
C1299487 (UMLS CUI [1])
Patient birth name
Item
Geburtsname
text
C1549652 (UMLS CUI [1])
Birth Date
Item
Geburtsdatum
date
C0421451 (UMLS CUI [1])
Patient address
Item
Adresse des Patienten
text
C0421449 (UMLS CUI [1])
Staging date
Item
Datum des Stagingabschlusses
date
C0027646 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Studien ID
integer
C2826693 (UMLS CUI [1])
Study ID
Code List
Studien ID
CL Item
HD16 (1)
CL Item
HD17 (2)
CL Item
HD18 (3)
CRF Indentificator
Item
Bogen ID
integer
C1516308 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Case ID
Item
Case ID
integer
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Beschwerden des Patienten
C3469071 (UMLS CUI-1)
B-Symptoms
Item
B-Symptomatik
text
C1706867 (UMLS CUI [1])
Weight loss
Item
Gewichtsabnahme > 10%/6 Monaten
boolean
C0936227 (UMLS CUI [1])
Fever
Item
Unklares Fieber > 38°C
boolean
C0015967 (UMLS CUI [1])
Night sweats
Item
Nachtschweiß
boolean
C0028081 (UMLS CUI [1])
Other symptoms
Item
Übrige
text
C0029625 (UMLS CUI [1])
Pruritus
Item
Juckreiz
boolean
C0033774 (UMLS CUI [1])
Alcohol-induced pain
Item
Alkoholschmerz
boolean
C1277603 (UMLS CUI [1])
Item Group
Laborwerte
C0022877 (UMLS CUI-1)
ESR
Item
BSG
integer
C1176468 (UMLS CUI [1])
WBC
Item
Leukozyten
float
C0023508 (UMLS CUI [1])
Lymphocytes
Item
Lymphozyten
integer
C0200635 (UMLS CUI [1])
Platelets
Item
Thrombozyten
integer
C0005821 (UMLS CUI [1])
Erythrocytes
Item
Erythrozyten
float
C0362910 (UMLS CUI [1])
Hb
Item
Hb
float
C0518015 (UMLS CUI [1])
Hb
Item
Hb-Wert
float
C0518015 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total Protein
Item
Gesamteiweiß
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
integer
C0201838 (UMLS CUI [1])
Creatinine clearance
Item
Kreatinine Clearance < 60ml/min
boolean
C0373595 (UMLS CUI [1])
Item Group
Aktivitätsindex (nach WHO)
C1298651 (UMLS CUI-1)
Item
Aktivitätsindex (nach WHO)
integer
C1298650 (UMLS CUI [1])
WHO Performance status
Code List
Aktivitätsindex (nach WHO)
CL Item
normale Aktivität,asymptomatisch (0)
C1271051 (UMLS CUI-1)
CL Item
leichte Arbeit möglich,symptomatisch (1)
C1271052 (UMLS CUI-1)
CL Item
Selbstversorgung möglich, <50% der Tageszeit bettlägerig (2)
C1271053 (UMLS CUI-1)
CL Item
begrenzte Selbstversorgung möglich, >50% der Tageszeit im Bett/Sessel (3)
C1271054 (UMLS CUI-1)
CL Item
voll pflegebedürftig (4)
C1271055 (UMLS CUI-1)
Body weight
Item
Körpergewicht
integer
C0005910 (UMLS CUI [1])
Body Height
Item
Körpergröße
integer
C0005890 (UMLS CUI [1])
Body surface
Item
Körperoberfläche
float
C0005902 (UMLS CUI [1])
Item Group
Begleiterkrankungen
C0150941 (UMLS CUI-1)
Concomitant diseases that are not in exclusion criteria
Item
Liegt eine Begleiterkrankung vor, die nicht als Ausschlußkriterium (s.E/A-Bogen) zu bewerten ist?
boolean
C0150941 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Concomitant diseases
Item
Welche Begleiterkrankung?
text
C0150941 (UMLS CUI [1])
Item
Hatte der Patient eine infektiöse Mononukleose?
integer
C0021345 (UMLS CUI [1])
Infectious mononucleosis
Code List
Hatte der Patient eine infektiöse Mononukleose?
CL Item
Ja (1)
CL Item
Nein (2)
CL Item
Unbekannt (3)
Item Group
Familienanamnese
C0241889 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
Traten in der Familie bereits maligne oder nicht maligne hämatologische Erkrankungen auf?
integer
C0018939 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
C0018939 (UMLS CUI [2,1])
C0205183 (UMLS CUI [2,2])
Infectious mononucleosis
Code List
Traten in der Familie bereits maligne oder nicht maligne hämatologische Erkrankungen auf?
CL Item
Ja (1)
CL Item
Nein (2)
CL Item
Unbekannt (3)
Item
HL
integer
C0019829 (UMLS CUI [1])
Hodgkin Lymphoma
Code List
HL
CL Item
Großeltern (1)
CL Item
Eltern (2)
CL Item
Geschwister (3)
CL Item
andere (4)
Item
NHL
integer
C0024305 (UMLS CUI [1])
Hodgkin Lymphoma
Code List
NHL
CL Item
Großeltern (1)
CL Item
Eltern (2)
CL Item
Geschwister (3)
CL Item
andere (4)
Item
CML
integer
C0023473 (UMLS CUI [1])
Hodgkin Lymphoma
Code List
CML
CL Item
Großeltern (1)
CL Item
Eltern (2)
CL Item
Geschwister (3)
CL Item
andere (4)
Item
CLL
integer
C0023434 (UMLS CUI [1])
Hodgkin Lymphoma
Code List
CLL
CL Item
Großeltern (1)
CL Item
Eltern (2)
CL Item
Geschwister (3)
CL Item
andere (4)
Item
AML
integer
C0023467 (UMLS CUI [1])
Hodgkin Lymphoma
Code List
AML
CL Item
Großeltern (1)
CL Item
Eltern (2)
CL Item
Geschwister (3)
CL Item
andere (4)
Item
ALL
integer
C0023449 (UMLS CUI [1])
Hodgkin Lymphoma
Code List
ALL
CL Item
Großeltern (1)
CL Item
Eltern (2)
CL Item
Geschwister (3)
CL Item
andere (4)
Item
Multiples Myelom
integer
C0026764 (UMLS CUI [1])
Hodgkin Lymphoma
Code List
Multiples Myelom
CL Item
Großeltern (1)
CL Item
Eltern (2)
CL Item
Geschwister (3)
CL Item
andere (4)
Item
Multiple Sklerose
integer
C0026769 (UMLS CUI [1])
Hodgkin Lymphoma
Code List
Multiple Sklerose
CL Item
Großeltern (1)
CL Item
Eltern (2)
CL Item
Geschwister (3)
CL Item
andere (4)
Item
Sarkoidose
integer
C0036202 (UMLS CUI [1])
Hodgkin Lymphoma
Code List
Sarkoidose
CL Item
Großeltern (1)
CL Item
Eltern (2)
CL Item
Geschwister (3)
CL Item
andere (4)
Item Group
Bemerkungen
C0947611 (UMLS CUI-1)
Date of completion
Item
Datum
date
C0011008 (UMLS CUI [1])
Signature
Item
Unterschrift
text
C1519316 (UMLS CUI [1])
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