ID

18442

Beschreibung

Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00384553

Link

https://clinicaltrials.gov/show/NCT00384553

Stichworte

Versionen (1)
  1. 04.11.16 04.11.16 -
Hochgeladen am

4. November 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-Hodgkin's Lymphoma NCT00384553

Englisch

Eligibility Non-Hodgkin's Lymphoma NCT00384553

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
first relapse or primary refractory disease of aggressive non-hodgkin's lymphoma stage i-iv
Beschreibung

Aggressive Non-Hodgkin Lymphoma First Relapse | Aggressive Non-Hodgkin Lymphoma Primary Refractory | Lymphoma stage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1332225
UMLS CUI [1,2]
C4054953
UMLS CUI [2,1]
C1332225
UMLS CUI [2,2]
C2347678
UMLS CUI [3]
C1272836
pretreatment with systemic therapy
Beschreibung

systemic therapy Pretreatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C3539076
18-65 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
performance status:ecog 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
granulocyte count >1.5/µm3, platelet count >100/µm3
Beschreibung

Granulocyte count | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0032181
creatinine -clearance ≥ 1 ml/sec
Beschreibung

Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
gpt/got ≤ 1.5 x normal (except tumour related)
Beschreibung

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement Related Malignant Neoplasms | Aspartate aminotransferase measurement Related Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3,1]
C0201836
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0006826
UMLS CUI [4,1]
C0201899
UMLS CUI [4,2]
C0439849
UMLS CUI [4,3]
C0006826
bilirubine < 22 µmol/l
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
no participation in another study 3 month before and during this study −informed consent
Beschreibung

Study Subject Participation Status | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
second neoplasia in history or existing except basalioma or squamous epithelium carcinoma of the skin or removed cervical intraepithelial neoplasia
Beschreibung

Neoplasms, Second Primary | Basal cell carcinoma | Squamous cell carcinoma of skin | Cervical Intraepithelial Neoplasia Removed

Datentyp

boolean

Alias
UMLS CUI [1]
C0085183
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
UMLS CUI [4,1]
C0206708
UMLS CUI [4,2]
C0849355
cns- involvement by lymphoma
Beschreibung

Lymphoma Central Nervous System Involvement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C4050309
respiratory partial- or global insufficiency
Beschreibung

Respiratory Insufficiency Partial | Respiratory Insufficiency Global

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035229
UMLS CUI [1,2]
C0728938
UMLS CUI [2,1]
C0035229
UMLS CUI [2,2]
C2348867
cardiac insufficiency (nyha-stage 3-4, ef < 30 %)
Beschreibung

Heart failure | New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C1275491
severe neurological or psychiatric disease
Beschreibung

nervous system disorder Severe | Mental disorder Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205082
pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
hiv positivity ,active virus hepatitis, bacterial infection − no follow up procedures ensured
Beschreibung

HIV Seropositivity | Viral hepatitis | Bacterial Infections | Follow-up status Limited

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0042721
UMLS CUI [3]
C0004623
UMLS CUI [4,1]
C0589120
UMLS CUI [4,2]
C0439801
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Ähnliche Modelle

Eligibility Non-Hodgkin's Lymphoma NCT00384553

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Aggressive Non-Hodgkin Lymphoma First Relapse | Aggressive Non-Hodgkin Lymphoma Primary Refractory | Lymphoma stage
Item
first relapse or primary refractory disease of aggressive non-hodgkin's lymphoma stage i-iv
boolean
C1332225 (UMLS CUI [1,1])
C4054953 (UMLS CUI [1,2])
C1332225 (UMLS CUI [2,1])
C2347678 (UMLS CUI [2,2])
C1272836 (UMLS CUI [3])
systemic therapy Pretreatment
Item
pretreatment with systemic therapy
boolean
C1515119 (UMLS CUI [1,1])
C3539076 (UMLS CUI [1,2])
Age
Item
18-65 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
performance status:ecog 0-2
boolean
C1520224 (UMLS CUI [1])
Granulocyte count | Platelet Count measurement
Item
granulocyte count >1.5/µm3, platelet count >100/µm3
boolean
C0857490 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Creatinine clearance measurement
Item
creatinine -clearance ≥ 1 ml/sec
boolean
C0373595 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement Related Malignant Neoplasms | Aspartate aminotransferase measurement Related Malignant Neoplasms
Item
gpt/got ≤ 1.5 x normal (except tumour related)
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0006826 (UMLS CUI [3,3])
C0201899 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C0006826 (UMLS CUI [4,3])
Serum total bilirubin measurement
Item
bilirubine < 22 µmol/l
boolean
C1278039 (UMLS CUI [1])
Study Subject Participation Status | Informed Consent
Item
no participation in another study 3 month before and during this study −informed consent
boolean
C2348568 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Neoplasms, Second Primary | Basal cell carcinoma | Squamous cell carcinoma of skin | Cervical Intraepithelial Neoplasia Removed
Item
second neoplasia in history or existing except basalioma or squamous epithelium carcinoma of the skin or removed cervical intraepithelial neoplasia
boolean
C0085183 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0206708 (UMLS CUI [4,1])
C0849355 (UMLS CUI [4,2])
Lymphoma Central Nervous System Involvement
Item
cns- involvement by lymphoma
boolean
C0024299 (UMLS CUI [1,1])
C4050309 (UMLS CUI [1,2])
Respiratory Insufficiency Partial | Respiratory Insufficiency Global
Item
respiratory partial- or global insufficiency
boolean
C0035229 (UMLS CUI [1,1])
C0728938 (UMLS CUI [1,2])
C0035229 (UMLS CUI [2,1])
C2348867 (UMLS CUI [2,2])
Heart failure | New York Heart Association Classification
Item
cardiac insufficiency (nyha-stage 3-4, ef < 30 %)
boolean
C0018801 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
nervous system disorder Severe | Mental disorder Severe
Item
severe neurological or psychiatric disease
boolean
C0027765 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
HIV Seropositivity | Viral hepatitis | Bacterial Infections | Follow-up status Limited
Item
hiv positivity ,active virus hepatitis, bacterial infection − no follow up procedures ensured
boolean
C0019699 (UMLS CUI [1])
C0042721 (UMLS CUI [2])
C0004623 (UMLS CUI [3])
C0589120 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
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