ID

28334

Beschreibung

NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Stichworte

Versionen (2)
  1. 30/11/2017 30/11/2017 -
  2. 04/01/2018 04/01/2018 -
Rechteinhaber

Prof. Dr. med. Georg Heß

Hochgeladen am

4 janvier 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

Englisch

Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

1 Formulare  
Admininstrative data
Beschreibung

Admininstrative data

Alias
UMLS CUI-1
C1320722
Subject ID
Beschreibung

Subject ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Patients aged >=18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Trial Protocol Version 1.0: 2. CD20 positive disease
Beschreibung

Trial Protocol Version 2.0: Criterion 2 removed.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3888518
3. Histologically proven diagnosis of diffuse large cell B-cell lymphoma, follicular lymphoma IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review)
Beschreibung

Diagnosis lymphoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0024299
4. Relapsed disease
Beschreibung

Relapsed disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0277556
5. ECOG performance status =< 2, unless tumor associated
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Trial protocol version 1.0: 6. LVEF >= 45% and normal serum troponin
Beschreibung

LVEF

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
Trial protocol Version 2.0: 6. Adequate cardiac reserve
Beschreibung

Serum troponin level must be consistent with no significant acute or chronic myocardial damage and there should be no evidence of symptomatic disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232164
UMLS CUI [1,2]
C2347957
7. No curative option available
Beschreibung

cure no

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1880198
UMLS CUI [1,2]
C1298908
8. At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
Beschreibung

tumor mass

Datentyp

boolean

Alias
UMLS CUI [1]
C3273930
9. Signed informed consent
Beschreibung

informed consent signed

Datentyp

boolean

Alias
UMLS CUI [1]
C0742766
10. Adequate bone marrow reserve / hepatic and renal function
Beschreibung

Adequate bone marrow reserve: - Platelets of at least 100.000/μl (in case of extensive BM-Infiltration 75.000/μl may be acceptable after discussion with the coordinating investigator); - absolute neutrophil count of at least 1000/μl . Adequate hepatic and renal function: - ALT < 2.5 x upper limit of normal (ULN); - AST < 2.5 x ULN; - total Bilirubin < 1.5 x ULN.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C2347957
UMLS CUI [1,3]
C0232741
UMLS CUI [1,4]
C0232804
11. No active Hepatitis B or C or HIV-infection
Beschreibung

Hepatitis B Hepatitis C HIV-infection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0019196
UMLS CUI [1,3]
C0019693
12. Measured or calculated creatinine clearance > 30 ml/min
Beschreibung

creatinine clearance

Datentyp

boolean

Alias
UMLS CUI [1]
C0812399
13. Fresh tumor biopsy or archived tissue available
Beschreibung

Fresh tumor biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C2827486
14. Ability of patient to understand nature, importance and individual consequences of clinical trial
Beschreibung

compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
15. Women post-menopausal for more than two years can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (Serum or Urine) is available before trial and they are willing to practice a highly effective and medically accepted contraception method during trial and for a period of 18 months post-treatment.
Beschreibung

Reliable contraception comprises systematic contraceptives (oral, implant, injection) or diaphragm / condoms /intrauterine devices (IUP) with spermicide.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0232970
16. Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment
Beschreibung

contraception male patients

Datentyp

boolean

Alias
UMLS CUI [1]
C0086580
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Ähnliche Modelle

Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Admininstrative data
C1320722 (UMLS CUI-1)
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
1. Patients aged >=18 years
boolean
C0001779 (UMLS CUI [1])
disease CD20 positive
Item
Trial Protocol Version 1.0: 2. CD20 positive disease
boolean
C0012634 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
Diagnosis lymphoma
Item
3. Histologically proven diagnosis of diffuse large cell B-cell lymphoma, follicular lymphoma IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review)
boolean
C0011900 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Relapsed disease
Item
4. Relapsed disease
boolean
C0277556 (UMLS CUI [1])
ECOG performance status
Item
5. ECOG performance status =< 2, unless tumor associated
boolean
C1520224 (UMLS CUI [1])
LVEF
Item
Trial protocol version 1.0: 6. LVEF >= 45% and normal serum troponin
boolean
C0428772 (UMLS CUI [1])
cardiac reserve
Item
Trial protocol Version 2.0: 6. Adequate cardiac reserve
boolean
C0232164 (UMLS CUI [1,1])
C2347957 (UMLS CUI [1,2])
cure no
Item
7. No curative option available
boolean
C1880198 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
tumor mass
Item
8. At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
boolean
C3273930 (UMLS CUI [1])
informed consent signed
Item
9. Signed informed consent
boolean
C0742766 (UMLS CUI [1])
bone marrow hepatic and renal function
Item
10. Adequate bone marrow reserve / hepatic and renal function
boolean
C0005953 (UMLS CUI [1,1])
C2347957 (UMLS CUI [1,2])
C0232741 (UMLS CUI [1,3])
C0232804 (UMLS CUI [1,4])
Hepatitis B Hepatitis C HIV-infection
Item
11. No active Hepatitis B or C or HIV-infection
boolean
C0019163 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0019693 (UMLS CUI [1,3])
creatinine clearance
Item
12. Measured or calculated creatinine clearance > 30 ml/min
boolean
C0812399 (UMLS CUI [1])
Fresh tumor biopsy
Item
13. Fresh tumor biopsy or archived tissue available
boolean
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C2827486 (UMLS CUI [1,3])
compliance
Item
14. Ability of patient to understand nature, importance and individual consequences of clinical trial
boolean
C1321605 (UMLS CUI [1])
childbearing potential post-menopausal
Item
15. Women post-menopausal for more than two years can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (Serum or Urine) is available before trial and they are willing to practice a highly effective and medically accepted contraception method during trial and for a period of 18 months post-treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [1,3])
contraception male patients
Item
16. Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment
boolean
C0086580 (UMLS CUI [1])
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