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ID
22062
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)
- 5/17/17 5/17/17 -
- 11/1/18 11/1/18 - Sarah Riepenhausen
Uploaded on
May 17, 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 Long term toxicity Base G6LT DRKS00003455 DRKS00003457
Deutsche Hodgkin Studiengruppe: G6LT Basisbogen Langzeittoxizität
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Deutsche Hodgkin Studiengruppe: G6LT Basisbogen Langzeittoxizität
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
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])
Physical Examination date
Item
Datum der Untersuchung
date
C2826643 (UMLS CUI [1])
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])
C0600091 (UMLS CUI [1,2])
Case ID
Item
Case ID
integer
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Item Group
Anamnese Kardio
C0007189 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0262926 (UMLS CUI-2)
CL Item
Nein (1)
C1298908 (UMLS CUI-1)
CL Item
Ja,keine Therapie (2)
C0746919 (UMLS CUI-1)
CL Item
Ja, Therapie (3)
C0087111 (UMLS CUI-1)
Coronary heart disease treatment
Item
KHK Therapie mit:
text
C0010068 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
CL Item
Nein (1)
C1298908 (UMLS CUI-1)
CL Item
Ja,keine Therapie (2)
C0746919 (UMLS CUI-1)
CL Item
Ja, Therapie (3)
C0087111 (UMLS CUI-1)
Hypertension treatment
Item
Hypertonie Therapie mit:
text
C0578998 (UMLS CUI [1])
CL Item
Nein (1)
C1298908 (UMLS CUI-1)
CL Item
Ja,keine Therapie (2)
C0746919 (UMLS CUI-1)
CL Item
Ja, Therapie (3)
C0087111 (UMLS CUI-1)
Hypercholesterolemia treatment
Item
Hypercholesterinämie Therapie mit:
text
C0020443 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
CL Item
Nein (1)
C1298908 (UMLS CUI-1)
CL Item
Ja,keine Therapie (2)
C0746919 (UMLS CUI-1)
CL Item
Ja, Therapie (3)
C0087111 (UMLS CUI-1)
Diabetes mellitus insulin dependent treatment
Item
Diabetes mellitus Typ I Therapie mit:
text
C0011854 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
CL Item
Nein (1)
C1298908 (UMLS CUI-1)
CL Item
Ja,keine Therapie (2)
C0746919 (UMLS CUI-1)
CL Item
Ja, Therapie (3)
C0087111 (UMLS CUI-1)
Item
Diabetes mellitus Typ II Therapie mit:
text
C0011860 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Family history of coronary heart disease
Item
Familäre KHK Belastung
boolean
C0455404 (UMLS CUI [1])
Myocardial Infarction
Item
Myokardinfarkt
boolean
C0027051 (UMLS CUI [1])
Smoking
Item
Rauchen
boolean
C0453996 (UMLS CUI [1])
Smoking pack years
Item
Rauchen: pack years
integer
C0453996 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
C1277691 (UMLS CUI [1,2])
Thrombosis susceptibility
Item
Thromboseneigung
boolean
C4016042 (UMLS CUI [1])
CL Item
Nein (1)
C1298908 (UMLS CUI-1)
CL Item
Ja,Minimum tägl. 30 min (2)
C1705108 (UMLS CUI-1)
C0565665 (UMLS CUI-2)
C0565665 (UMLS CUI-2)
CL Item
Ja,Sport (3)
C1705108 (UMLS CUI-1)
C0038039 (UMLS CUI-2)
C0038039 (UMLS CUI-2)
Echocardiography
Item
Echokardiographie
text
C0013516 (UMLS CUI [1])
LVEF
Item
LVEF
integer
C0428772 (UMLS CUI [1])
E/A
Item
E/A
integer
C2059591 (UMLS CUI [1])
Deceleration Time
Item
DT
integer
C0882996 (UMLS CUI [1])
Tei Index
Item
Tei Index
float
C2923433 (UMLS CUI [1])
Pericardial effusion
Item
Perikarderguss
boolean
C0031039 (UMLS CUI [1])
Pericardial effusion
Item
Perikarderguss
integer
C0031039 (UMLS CUI [1])
Heart valve dysfunction
Item
Klappenfunktionsstörungen
boolean
C0018826 (UMLS CUI [1,1])
C0277785 (UMLS CUI [1,2])
C0277785 (UMLS CUI [1,2])
Heart valve dysfunction
Item
Klappenfunktionsstörungen:ja folgende
text
C0018826 (UMLS CUI [1,1])
C2983555 (UMLS CUI [1,2])
C2983555 (UMLS CUI [1,2])
Regional cardiac wall motion dysfunction
Item
Regionale Wandbewegungsstörungen
boolean
C2024775 (UMLS CUI [1])
Regional cardiac wall motion dysfunction type
Item
Regionale Wandbewegungsstörungen:ja folgende
text
C2024775 (UMLS CUI [1])
ECG
Item
EKG
text
C1623258 (UMLS CUI [1])
Heart rate
Item
Herzfrequenz
integer
C0018810 (UMLS CUI [1])
ECG findings
Item
Pathologischer Befund
boolean
C0438154 (UMLS CUI [1])
ECG findings
Item
Pathologischer Befund: ja folgender
text
C0438154 (UMLS CUI [1])
Blood pressure systolic
Item
RR systolisch
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
RR diastolisch
integer
C0428883 (UMLS CUI [1])
Serology
Item
Serologie
text
C0036743 (UMLS CUI [1])
Creatinine
Item
Kreatinin
float
C0201976 (UMLS CUI [1])
Unit used
Item
Einheit
text
C1519795 (UMLS CUI [1])
Serum Troponin T test and NTproBNP
Item
10 ml Serum für NTproBNP und Troponin T verschickt
boolean
C0585642 (UMLS CUI [1])
C1963813 (UMLS CUI [2])
C1963813 (UMLS CUI [2])
Item Group
Anamnese Fertilität
C0262926 (UMLS CUI-1)
C0015895 (UMLS CUI-2)
C0015895 (UMLS CUI-2)
Medical history fertility
Item
Anamnese Fertilität
boolean
C0262926 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0015895 (UMLS CUI [1,2])
Item
Zyklusanamnese/Spermiogramm
integer
C0025329 (UMLS CUI [1])
C0202533 (UMLS CUI [2])
C0202533 (UMLS CUI [2])
CL Item
Nein,nicht erfolgt (1)
C1272696 (UMLS CUI-1)
CL Item
Ja,ohne pathologischen Befund (2)
C1513916 (UMLS CUI-1)
CL Item
Ja, pathologischer Befund (3)
C1514241 (UMLS CUI-1)
Item
Zyklusanamnese/Spermiogramm: pathologischer Befund
text
C0025329 (UMLS CUI [1])
C0202533 (UMLS CUI [2])
C0202533 (UMLS CUI [2])
Contraception
Item
Kontrazeption
text
C0700589 (UMLS CUI [1])
Hormonal contraception prior to treatment
Item
Hormonelle Verhütung vor Therapie
boolean
C2985296 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Hormonal contraception method prior to treatment
Item
Hormonelle Verhütung vor Therapie ja mit:
text
C2985296 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Date last medication intake
Item
Letzte Einnahme
date
C4029433 (UMLS CUI [1])
Serology
Item
Serologie
text
C0036743 (UMLS CUI [1])
FSH
Item
FSH
integer
C0202022 (UMLS CUI [1])
Unit used
Item
Einheit
text
C1519795 (UMLS CUI [1])
LH
Item
LH
integer
C0202123 (UMLS CUI [1])
Unit used
Item
Einheit
text
C1519795 (UMLS CUI [1])
Beta estradiol
Item
ß-Östradiol
integer
C0014912 (UMLS CUI [1])
Unit used
Item
Einheit
text
C1519795 (UMLS CUI [1])
Testosterone
Item
Testosteron
float
C0523912 (UMLS CUI [1])
Unit used
Item
Einheit
text
C1519795 (UMLS CUI [1])
AMH
Item
AMH
float
C0066928 (UMLS CUI [1])
Unit used
Item
Einheit
text
C1519795 (UMLS CUI [1])
Inhibin B
Item
Inhibin B
integer
C3272959 (UMLS CUI [1])
Unit used
Item
Einheit
text
C1519795 (UMLS CUI [1])
Item
Wurde eine Kryokonservierung vorgenommen?
integer
C0010405 (UMLS CUI [1])
CL Item
Nein (1)
C1513916 (UMLS CUI-1)
CL Item
Ja (bitte folgendes ausfüllen) (2)
C1514241 (UMLS CUI-1)
Ovarian tissue cryopreservation
Item
Ovargewebe
boolean
C1314154 (UMLS CUI [1])
Sperm cryopreservation
Item
Spermien
boolean
C0519952 (UMLS CUI [1])
Cryopreservation of fertilized ovum
Item
Eizelle befruchtet
boolean
C0010405 (UMLS CUI [1,1])
C0043544 (UMLS CUI [1,2])
C0043544 (UMLS CUI [1,2])
Cryopreservation of oocyte
Item
Eizelle unbefruchtet
boolean
C1314155 (UMLS CUI [1])
Item
Anamnese Lunge
integer
C0024109 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
CL Item
Not done (falls nicht erfolgt) (1)
C1272696 (UMLS CUI-1)
CL Item
Ja (bitte ausfüllen) (2)
C1272695 (UMLS CUI-1)
History of respiratory disease
Item
Bekannte pulmonale Erkrankung
boolean
C0455540 (UMLS CUI [1])
History of respiratory disease
Item
Bekannte pulmonale Erkrankung
text
C0455540 (UMLS CUI [1])
CL Item
Therapie erforderlich (1)
C0815189 (UMLS CUI-1)
CL Item
Keine Therapie erforderlich (2)
C0087111 (UMLS CUI-1)
C0549184 (UMLS CUI-2)
C0549184 (UMLS CUI-2)
History of respiratory disease treatment
Item
Bekannte pulmonale Erkrankung Therapie mit:
text
C0455540 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
CL Item
Not done (falls nicht erfolgt) (1)
C1272696 (UMLS CUI-1)
CL Item
Ja (bitte ausfüllen) (2)
C1272695 (UMLS CUI-1)
Vital capacity
Item
Vitalkapazität
float
C0042834 (UMLS CUI [1])
DLCO
Item
DLCO
float
C1516251 (UMLS CUI [1])
pO2
Item
pO2
integer
C2317096 (UMLS CUI [1])
pCO2
Item
pCO2
integer
C0201931 (UMLS CUI [1])
CL Item
Nein,nicht erfolgt (1)
C1272696 (UMLS CUI-1)
CL Item
Ja,ohne pathologischen Befund (2)
C1513916 (UMLS CUI-1)
CL Item
Ja, pathologischer Befund (3)
C1514241 (UMLS CUI-1)
Chest x-ray finding
Item
Röntgen Thorax: Befund
text
C0039985 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,2])
Comments
Item
Bemerkungen
text
C0947611 (UMLS CUI [1])
Date of completion
Item
Datum
date
C0011008 (UMLS CUI [1])
Physician signature
Item
Unterschrift des Arztes
text
C1519316 (UMLS CUI [1])