ID

21832

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 (3)
  1. 4/24/17 4/24/17 -
  2. 5/3/17 5/3/17 -
  3. 11/1/18 11/1/18 - Sarah Riepenhausen
Uploaded on

May 3, 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 Final Report DRKS00003455 DRKS00003457

German

Deutsche Hodgkin Studiengruppe: Abschlussbogen

1 forms  
Formularkopf
Description

Formularkopf

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 histologischen Befundes
Description

Histology report date

Data type

date

Alias
UMLS CUI [1,1]
C0807321
UMLS CUI [1,2]
C011008
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
Patient verstorben
Description

Patient verstorben

Todesdatum
Description

Date of Death

Data type

date

Alias
UMLS CUI [1]
C1148348
Todesursache
Description

Freitext s.u.

Data type

integer

Alias
UMLS CUI [1]
C0007465
Sektion durchgeführt
Description

Autopsy done

Data type

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C0884358
Sektion durchgeführt am
Description

Autopsy date

Data type

date

Alias
UMLS CUI [1]
C3864942
Sektionsergebnis
Description

Autopsy result

Data type

integer

Alias
UMLS CUI [1]
C0332145
Wo wurde der Tumor aufgefunden?
Description

Neoplasm found

Data type

text

Alias
UMLS CUI [1]
C0332145
Hat eine Sekundärneoplasie vorgelegen?
Description

Second primary

Data type

boolean

Alias
UMLS CUI [1]
C0751623
Art der Sekundärneoplasie
Description

Second primary

Data type

integer

Alias
UMLS CUI [1]
C0751623
Diagnosedatum der Sekundärneoplasie
Description

Second primary date of diagnosis

Data type

date

Alias
UMLS CUI [1,1]
C0751623
UMLS CUI [1,2]
C2316983
Detaillierte Information zur Todesursache
Description

Bitte Kopie des letzten Arztbriefes beifügen

Data type

text

Alias
UMLS CUI [1,1]
C1533716
UMLS CUI [1,2]
C0007465
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: Abschlussbogen

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Formularkopf
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])
Histology report date
Item
Datum des histologischen Befundes
date
C0807321 (UMLS CUI [1,1])
C011008 (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
Patient verstorben
Date of Death
Item
Todesdatum
date
C1148348 (UMLS CUI [1])
Item
Todesursache
integer
C0007465 (UMLS CUI [1])
Cause of death
Code List
Todesursache
CL Item
Tumorbedingt (1)
CL Item
Therapiebedingt (2)
CL Item
Sekundärneoplasie (3)
CL Item
Unfall (4)
CL Item
Suizid (5)
CL Item
Sonstige (6)
Autopsy done
Item
Sektion durchgeführt
boolean
C0004398 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Autopsy date
Item
Sektion durchgeführt am
date
C3864942 (UMLS CUI [1])
Item
Sektionsergebnis
integer
C0332145 (UMLS CUI [1])
Autopsy result
Code List
Sektionsergebnis
CL Item
Tumor nicht auffindbar  (1)
CL Item
Tumor auffindbar (2)
Item
Wo wurde der Tumor aufgefunden?
text
C0332145 (UMLS CUI [1])
Autopsy result
Code List
Wo wurde der Tumor aufgefunden?
Second primary
Item
Hat eine Sekundärneoplasie vorgelegen?
boolean
C0751623 (UMLS CUI [1])
Item
Art der Sekundärneoplasie
integer
C0751623 (UMLS CUI [1])
Second primary
Code List
Art der Sekundärneoplasie
CL Item
Leukämie,MDS (1)
CL Item
NHL (2)
CL Item
Solider Tumor (3)
Second primary date of diagnosis
Item
Diagnosedatum der Sekundärneoplasie
date
C0751623 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Detailed information cause of death
Item
Detaillierte Information zur Todesursache
text
C1533716 (UMLS CUI [1,1])
C0007465 (UMLS CUI [1,2])
Date of completion
Item
Datum
date
C0011008 (UMLS CUI [1])
Signature
Item
Unterschrift
text
C1519316 (UMLS CUI [1])
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