ID

26003

Beskrivning

Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma(MZL); ODM derived from: https://clinicaltrials.gov/show/NCT01068392

Länk

https://clinicaltrials.gov/show/NCT01068392

Nyckelord

Versioner (2)
  1. 2017-10-02 2017-10-02 -
  2. 2017-10-04 2017-10-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 oktober 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility B-cell Lymphomas NCT01068392

Engelsk

Eligibility B-cell Lymphomas NCT01068392

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed marginal zone b-cell lymphomas
Beskrivning

Marginal Zone B-Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1367654
failure to achieve a clinical benefit (≥sd) with the initial treatment, or recurrent disease
Beskrivning

Neoadjuvant Therapy | Stable Disease failed | Recurrent disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0600558
UMLS CUI [2,1]
C0677946
UMLS CUI [2,2]
C0231175
UMLS CUI [3]
C0277556
performance status (ecog) ≤2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
age ≥ 20
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
at least one or more bi-dimensionally measurable lesion(s) defined as; ≥2 cm by conventional ct or ≥ 1 cm by spiral ct or skin lesion (photographs should be taken) or measurable lesion by physical examination
Beskrivning

Measurable Disease 2-Dimensional Quantity CT | Measurable Disease 2-Dimensional Quantity Spiral CT | Skin lesion Photograph | Measurable Disease Physical Examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0040405
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1705052
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0860888
UMLS CUI [3,1]
C0037284
UMLS CUI [3,2]
C0441468
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C0031809
adequate kidney functions defined as; cr < 2.0 mg% or ccr > 60 ml/min
Beskrivning

Renal function | Creatinine measurement, serum | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
adequate liver functions defined as; transaminases < 3 x upper normal values; bilirubin < 2 mg%
Beskrivning

Liver function | Transaminases | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0002594
UMLS CUI [3]
C1278039
adequate bone marrow functions defined as; anc > 1500/㎕, platelet > 75000/㎕
Beskrivning

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
ann arbor stage iii or iv
Beskrivning

Ann Arbor lymphoma staging system

Datatyp

boolean

Alias
UMLS CUI [1]
C0432516
ann arbor stage i or ii, which is not adequate for rt or surgical approach (e.g. multiple lung lesions, multiple colon involvement, remote abdominal ln with stomach involvement)
Beskrivning

Ann Arbor lymphoma staging system | Stage Inappropriate Therapeutic radiology procedure | Stage Inappropriate Surgical approach | Lesion of lung multiple | Involvement with Colon multiple | Abdominal lymph nodes Remote Involvement with Stomach

Datatyp

boolean

Alias
UMLS CUI [1]
C0432516
UMLS CUI [2,1]
C1300072
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C1522449
UMLS CUI [3,1]
C1300072
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0449446
UMLS CUI [4,1]
C0577916
UMLS CUI [4,2]
C0439064
UMLS CUI [5,1]
C1314939
UMLS CUI [5,2]
C1281569
UMLS CUI [5,3]
C0439064
UMLS CUI [6,1]
C0588058
UMLS CUI [6,2]
C0205157
UMLS CUI [6,3]
C1314939
UMLS CUI [6,4]
C0038351
written informed consent approved by institutional review board or ethic committee
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other malignancies within the past 5 years except skin basal cell ca or cis of cervix
Beskrivning

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
serious co-morbid diseases
Beskrivning

Comorbidity Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
pregnancy or breast feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous history of drug allergy to one of the drugs in the study regimen
Beskrivning

Hypersensitivity Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
during this study duration, patients who take other clinical trial medication, chemotherapy, hormonal therapy, or immunotherapy
Beskrivning

Investigational New Drugs | Chemotherapy | Hormone Therapy | Immunotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0021083
Tillbaka till toppen

Similar models

Eligibility B-cell Lymphomas NCT01068392

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Marginal Zone B-Cell Lymphoma
Item
histologically confirmed marginal zone b-cell lymphomas
boolean
C1367654 (UMLS CUI [1])
Neoadjuvant Therapy | Stable Disease failed | Recurrent disease
Item
failure to achieve a clinical benefit (≥sd) with the initial treatment, or recurrent disease
boolean
C0600558 (UMLS CUI [1])
C0677946 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3])
ECOG performance status
Item
performance status (ecog) ≤2
boolean
C1520224 (UMLS CUI [1])
Age
Item
age ≥ 20
boolean
C0001779 (UMLS CUI [1])
Measurable Disease 2-Dimensional Quantity CT | Measurable Disease 2-Dimensional Quantity Spiral CT | Skin lesion Photograph | Measurable Disease Physical Examination
Item
at least one or more bi-dimensionally measurable lesion(s) defined as; ≥2 cm by conventional ct or ≥ 1 cm by spiral ct or skin lesion (photographs should be taken) or measurable lesion by physical examination
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,4])
C1513041 (UMLS CUI [2,1])
C1705052 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0860888 (UMLS CUI [2,4])
C0037284 (UMLS CUI [3,1])
C0441468 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4,1])
C0031809 (UMLS CUI [4,2])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
adequate kidney functions defined as; cr < 2.0 mg% or ccr > 60 ml/min
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Liver function | Transaminases | Serum total bilirubin measurement
Item
adequate liver functions defined as; transaminases < 3 x upper normal values; bilirubin < 2 mg%
boolean
C0232741 (UMLS CUI [1])
C0002594 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
adequate bone marrow functions defined as; anc > 1500/㎕, platelet > 75000/㎕
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Ann Arbor lymphoma staging system
Item
ann arbor stage iii or iv
boolean
C0432516 (UMLS CUI [1])
Ann Arbor lymphoma staging system | Stage Inappropriate Therapeutic radiology procedure | Stage Inappropriate Surgical approach | Lesion of lung multiple | Involvement with Colon multiple | Abdominal lymph nodes Remote Involvement with Stomach
Item
ann arbor stage i or ii, which is not adequate for rt or surgical approach (e.g. multiple lung lesions, multiple colon involvement, remote abdominal ln with stomach involvement)
boolean
C0432516 (UMLS CUI [1])
C1300072 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C1300072 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0449446 (UMLS CUI [3,3])
C0577916 (UMLS CUI [4,1])
C0439064 (UMLS CUI [4,2])
C1314939 (UMLS CUI [5,1])
C1281569 (UMLS CUI [5,2])
C0439064 (UMLS CUI [5,3])
C0588058 (UMLS CUI [6,1])
C0205157 (UMLS CUI [6,2])
C1314939 (UMLS CUI [6,3])
C0038351 (UMLS CUI [6,4])
Informed Consent
Item
written informed consent approved by institutional review board or ethic committee
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
any other malignancies within the past 5 years except skin basal cell ca or cis of cervix
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Comorbidity Serious
Item
serious co-morbid diseases
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs
Item
previous history of drug allergy to one of the drugs in the study regimen
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Investigational New Drugs | Chemotherapy | Hormone Therapy | Immunotherapy
Item
during this study duration, patients who take other clinical trial medication, chemotherapy, hormonal therapy, or immunotherapy
boolean
C0013230 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial