ID

30408

Descripción

Observational Study of Diffuse Large B Cell Primary Breast Lymphomas Treated With RCHOP +/- XRT; ODM derived from: https://clinicaltrials.gov/show/NCT01144754

Link

https://clinicaltrials.gov/show/NCT01144754

Palabras clave

Versiones (1)
  1. 3/6/18 3/6/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

3 de junio de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma NCT01144754

Inglés

Eligibility Lymphoma NCT01144754

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01144754
Inclusion Criteria
Descripción

Inclusion Criteria

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

Breast Diffuse Large B-Cell Lymphoma untreated

Tipo de datos

boolean

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

Neoplasms CD20 positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0882818
stage ie or iie.
Descripción

Ann Arbor lymphoma staging system

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0432516
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.
Descripción

Measurable Disease Quantity | Evaluable Disease Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1516986
UMLS CUI [2,2]
C1265611
patients must not have historical or radiographic evidence of cns metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
Descripción

CNS metastases Absent Radiography | Absence Prior Therapy Lesion of brain | Absence Lesion of brain Resected | Absence Lesion of brain Asymptomatic | Absence Involvement with Leptomeninges

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0034571
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1514463
UMLS CUI [2,3]
C0221505
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0221505
UMLS CUI [3,3]
C1521996
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0221505
UMLS CUI [4,3]
C0231221
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C1314939
UMLS CUI [5,3]
C0228126
patients must have an ecog performance status 0-2.
Descripción

ECOG performance status

Tipo de datos

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):
Descripción

Organ function | Laboratory Procedures

Tipo de datos

boolean

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

Creatinine clearance measurement

Tipo de datos

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
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3,1]
C0441932
UMLS CUI [3,2]
C0024299
*uln, and ast <= 5 x uln.
Descripción

Aspartate aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201899
absolute neutrophil count >= 1500/mm3 and platelet count >= 100,000/mm3. if documented bone marrow involvement with lymphoma, absolute neutrophil count >= 500/mm^3 and platelet count >= 50,000/mm^3.
Descripción

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

Tipo de datos

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.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
women must not be pregnant or breast feeding due to potential harmful effects to the fetus/baby. women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
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
patients must not have an active infection requiring parental antibiotics.
Descripción

Communicable Disease Absent | Requirement Antibiotics Parenteral

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0003232
UMLS CUI [2,3]
C1518896
patients with known hiv infection are excluded.
Descripción

HIV Infection Excluded

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0332196
patients must have a normal left ventricular ejection fraction to be eligible.
Descripción

Left ventricular ejection fraction Normal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0205307
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Similar models

Eligibility Lymphoma NCT01144754

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01144754
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Neoplasms CD20 positive
Item
patients must have cd20 positive tumors.
boolean
C0027651 (UMLS CUI [1,1])
C0882818 (UMLS CUI [1,2])
Ann Arbor lymphoma staging system
Item
stage ie or iie.
boolean
C0432516 (UMLS CUI [1])
Measurable Disease Quantity | Evaluable Disease Quantity
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])
CNS metastases Absent Radiography | Absence Prior Therapy Lesion of brain | Absence Lesion of brain Resected | Absence Lesion of brain Asymptomatic | Absence Involvement with Leptomeninges
Item
patients must not have historical or radiographic evidence of cns metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
boolean
C0686377 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C0221505 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0221505 (UMLS CUI [3,2])
C1521996 (UMLS CUI [3,3])
C0332197 (UMLS CUI [4,1])
C0221505 (UMLS CUI [4,2])
C0231221 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C0228126 (UMLS CUI [5,3])
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])
C0022885 (UMLS CUI [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
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0441932 (UMLS CUI [3,1])
C0024299 (UMLS CUI [3,2])
Aspartate aminotransferase measurement
Item
*uln, and ast <= 5 x uln.
boolean
C0201899 (UMLS CUI [1])
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/mm^3 and platelet count >= 50,000/mm^3.
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])
Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Contraceptive methods | Gender Sexually active Contraceptive methods
Item
women must not be pregnant or breast feeding due to potential harmful effects to the fetus/baby. women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
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 Absent | Requirement Antibiotics Parenteral
Item
patients must not have an active infection requiring parental antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0003232 (UMLS CUI [2,2])
C1518896 (UMLS CUI [2,3])
HIV Infection Excluded
Item
patients with known hiv infection are excluded.
boolean
C0019693 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
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])
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