ID

39050

Beschrijving

This Trial is a Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT01279772

Link

https://clinicaltrials.gov/show/NCT01279772

Trefwoorden

Versies (1)
  1. 24-11-19 24-11-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

24 november 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diffuse Large B Cell Lymphoma of the Breast. NCT01279772

Engels

Eligibility Diffuse Large B Cell Lymphoma of the Breast. NCT01279772

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
previously untreated patients with dlbcl of the breast.
Beschrijving

Breast Diffuse Large B-Cell Lymphoma Untreated

Datatype

boolean

Alias
UMLS CUI [1,1]
C1511306
UMLS CUI [1,2]
C0332155
patients must have cd20 positive tumors.
Beschrijving

Neoplasm CD20 antigen positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3888518
stage ie or iie.
Beschrijving

TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
must have at least one objective measurable or evaluable disease. baseline measurements and evaluations must be obtained within 4 weeks of registration to the study.
Beschrijving

Measurable Disease Quantity | Evaluable Disease Quantity | Baseline Measurement | Baseline Evaluation

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1516986
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1442488
UMLS CUI [3,2]
C0242485
UMLS CUI [4,1]
C1442488
UMLS CUI [4,2]
C1261322
patients must have an ecog performance status 0-2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
patients must have adequate organ function as evidenced by the following laboratory studies ( within 2 weeks prior to registration):
Beschrijving

Organ function Laboratory Procedures

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0022885
creatinine clearance > 50 ml/min
Beschrijving

Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
total bilirubin < 2.0 mg/dl and ast < 2 x upper limit of normal. if documented hepatic involvement with lymphoma, total bilirubin can be < 3 x uln, and ast < 5 x uln.
Beschrijving

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Hepatic Involvement Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3,1]
C0441932
UMLS CUI [3,2]
C0024299
absolute neutrophil count > 1500/mm3 and platelet count > 100,000/mm3. if documented bone marrow involvement with lymphoma, absolute neutrophil count > 500/mm3 and platelet count > 50,000/mm3.
Beschrijving

Absolute neutrophil count | Platelet Count measurement | Bone Marrow Involvement Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3,1]
C1517677
UMLS CUI [3,2]
C0024299
patients must be age > 18 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients must have a normal left ventricular ejection fraction to be eligible.
Beschrijving

Left ventricular ejection fraction Normal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0205307
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
historical or radiographic evidence of cns metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
Beschrijving

CNS metastases | CNS metastases Radiography | Prior Therapy Lesion of brain | Lesion of brain Resected | Lesion of brain Asymptomatic | Involvement Leptomeningeal

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0034571
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0221505
UMLS CUI [4,1]
C0221505
UMLS CUI [4,2]
C1521996
UMLS CUI [5,1]
C0221505
UMLS CUI [5,2]
C0231221
UMLS CUI [6,1]
C1314939
UMLS CUI [6,2]
C0521401
pregnant or breast feeding patients. women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Gender Sexually active Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0241028
UMLS CUI [4,3]
C0700589
active infection requiring parental antibiotics.
Beschrijving

Communicable Disease Requirement Antibiotics Parenteral

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003232
UMLS CUI [1,4]
C1518896
known hiv infection
Beschrijving

HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
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Similar models

Eligibility Diffuse Large B Cell Lymphoma of the Breast. NCT01279772

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast Diffuse Large B-Cell Lymphoma Untreated
Item
previously untreated patients with dlbcl of the breast.
boolean
C1511306 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Neoplasm CD20 antigen positive
Item
patients must have cd20 positive tumors.
boolean
C0027651 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
TNM clinical staging
Item
stage ie or iie.
boolean
C3258246 (UMLS CUI [1])
Measurable Disease Quantity | Evaluable Disease Quantity | Baseline Measurement | Baseline Evaluation
Item
must have at least one objective measurable or evaluable disease. baseline measurements and evaluations must be obtained within 4 weeks of registration to the study.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1516986 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1442488 (UMLS CUI [3,1])
C0242485 (UMLS CUI [3,2])
C1442488 (UMLS CUI [4,1])
C1261322 (UMLS CUI [4,2])
ECOG performance status
Item
patients must have an ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Organ function Laboratory Procedures
Item
patients must have adequate organ function as evidenced by the following laboratory studies ( within 2 weeks prior to registration):
boolean
C0678852 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Creatinine clearance measurement
Item
creatinine clearance > 50 ml/min
boolean
C0373595 (UMLS CUI [1])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Hepatic Involvement Lymphoma
Item
total bilirubin < 2.0 mg/dl and ast < 2 x upper limit of normal. if documented hepatic involvement with lymphoma, total bilirubin can be < 3 x uln, and ast < 5 x uln.
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0441932 (UMLS CUI [3,1])
C0024299 (UMLS CUI [3,2])
Absolute neutrophil count | Platelet Count measurement | Bone Marrow Involvement Lymphoma
Item
absolute neutrophil count > 1500/mm3 and platelet count > 100,000/mm3. if documented bone marrow involvement with lymphoma, absolute neutrophil count > 500/mm3 and platelet count > 50,000/mm3.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C1517677 (UMLS CUI [3,1])
C0024299 (UMLS CUI [3,2])
Age
Item
patients must be age > 18 years.
boolean
C0001779 (UMLS CUI [1])
Left ventricular ejection fraction Normal
Item
patients must have a normal left ventricular ejection fraction to be eligible.
boolean
C0428772 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
CNS metastases | CNS metastases Radiography | Prior Therapy Lesion of brain | Lesion of brain Resected | Lesion of brain Asymptomatic | Involvement Leptomeningeal
Item
historical or radiographic evidence of cns metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
boolean
C0686377 (UMLS CUI [1])
C0686377 (UMLS CUI [2,1])
C0034571 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0221505 (UMLS CUI [3,2])
C0221505 (UMLS CUI [4,1])
C1521996 (UMLS CUI [4,2])
C0221505 (UMLS CUI [5,1])
C0231221 (UMLS CUI [5,2])
C1314939 (UMLS CUI [6,1])
C0521401 (UMLS CUI [6,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Gender Sexually active Contraceptive methods
Item
pregnant or breast feeding patients. women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0241028 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
Communicable Disease Requirement Antibiotics Parenteral
Item
active infection requiring parental antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C1518896 (UMLS CUI [1,4])
HIV Infection
Item
known hiv infection
boolean
C0019693 (UMLS CUI [1])
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