ID

31532

Description

A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00944567

Lien

https://clinicaltrials.gov/show/NCT00944567

Mots-clés

Versions (1)
  1. 01/09/2018 01/09/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

1 septembre 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Primary Mediastinal B-Cell Lymphoma NCT00944567

Anglais

Eligibility Primary Mediastinal B-Cell Lymphoma NCT00944567

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary mediastinal diffuse large b-cell lymphoma, cd20 positive. patients must have histological confirmation of the diagnosis, and in addition have a dominant mass within the anterior mediastinum.
Description

Mediastinal Large B-Cell Lymphoma CD20 positive | Mass Predominant Anterior mediastinum

Type de données

boolean

Alias
UMLS CUI [1,1]
C1292754
UMLS CUI [1,2]
C3888518
UMLS CUI [2,1]
C3273930
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C0230148
no prior treatment of lymphoma. patients may have received corticosteroids for up to 1 week for the relief of local compressive symptoms.
Description

Prior Therapy Absent Lymphoma | Adrenal Cortex Hormones Symptoms Relief

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0024299
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C0564405
any stage of disease.
Description

Disease Stage Any

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1306673
UMLS CUI [1,3]
C1552551
age at least 18 years.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
fit to receive chemotherapy with curative intent.
Description

Fit Chemotherapy Curative intent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0424576
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1276305
able and willing to give informed consent, and to undergo staging including pet scanning
Description

Informed Consent | Consent Staging | Consent Positron-Emission Tomography

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C1511481
UMLS CUI [2,2]
C0332305
UMLS CUI [3,1]
C1511481
UMLS CUI [3,2]
C0032743
willingness to comply with an appropriate contraceptive method in women of childbearing potential or men.
Description

Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
Description

Heart Disease | Ventricular arrhythmia Symptomatic | Congestive heart failure | Myocardial Infarction

Type de données

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0085612
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0027051
impairment of bone marrow function (wbc <3.0x109/l, anc <1.5x109/l, plt <100x109/l), unless due to involvement by lymphoma.
Description

Bone Marrow function Impairment | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Exception Involvement with Lymphoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0221099
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1314939
UMLS CUI [5,3]
C0024299
major impairment of renal function (serum creatinine >2x upper normal) or liver function (asat/alat >2,5 upper normal, total bilirubin >2,5x upper normal), unless due to lymphoma involvement.
Description

Renal Insufficiency Major | Serum creatinine raised | Liver Dysfunction Major | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin | Exception Involvement with Lymphoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0700225
UMLS CUI [3,1]
C0086565
UMLS CUI [3,2]
C0205164
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0151905
UMLS CUI [6]
C0741494
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1314939
UMLS CUI [7,3]
C0024299
known hiv infection. patients will not be tested routinely.
Description

HIV Infection

Type de données

boolean

Alias
UMLS CUI [1]
C0019693
pregnant or lactating women.
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Description

Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0241888
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0525058
UMLS CUI [3,1]
C3850138
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0017444
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
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Similar models

Eligibility Primary Mediastinal B-Cell Lymphoma NCT00944567

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Mediastinal Large B-Cell Lymphoma CD20 positive | Mass Predominant Anterior mediastinum
Item
primary mediastinal diffuse large b-cell lymphoma, cd20 positive. patients must have histological confirmation of the diagnosis, and in addition have a dominant mass within the anterior mediastinum.
boolean
C1292754 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
C3273930 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C0230148 (UMLS CUI [2,3])
Prior Therapy Absent Lymphoma | Adrenal Cortex Hormones Symptoms Relief
Item
no prior treatment of lymphoma. patients may have received corticosteroids for up to 1 week for the relief of local compressive symptoms.
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0564405 (UMLS CUI [2,3])
Disease Stage Any
Item
any stage of disease.
boolean
C0012634 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Age
Item
age at least 18 years.
boolean
C0001779 (UMLS CUI [1])
Fit Chemotherapy Curative intent
Item
fit to receive chemotherapy with curative intent.
boolean
C0424576 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])
Informed Consent | Consent Staging | Consent Positron-Emission Tomography
Item
able and willing to give informed consent, and to undergo staging including pet scanning
boolean
C0021430 (UMLS CUI [1])
C1511481 (UMLS CUI [2,1])
C0332305 (UMLS CUI [2,2])
C1511481 (UMLS CUI [3,1])
C0032743 (UMLS CUI [3,2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
willingness to comply with an appropriate contraceptive method in women of childbearing potential or men.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Heart Disease | Ventricular arrhythmia Symptomatic | Congestive heart failure | Myocardial Infarction
Item
evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
boolean
C0018799 (UMLS CUI [1])
C0085612 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Bone Marrow function Impairment | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Exception Involvement with Lymphoma
Item
impairment of bone marrow function (wbc <3.0x109/l, anc <1.5x109/l, plt <100x109/l), unless due to involvement by lymphoma.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C0024299 (UMLS CUI [5,3])
Renal Insufficiency Major | Serum creatinine raised | Liver Dysfunction Major | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin | Exception Involvement with Lymphoma
Item
major impairment of renal function (serum creatinine >2x upper normal) or liver function (asat/alat >2,5 upper normal, total bilirubin >2,5x upper normal), unless due to lymphoma involvement.
boolean
C1565489 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0700225 (UMLS CUI [2])
C0086565 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0151904 (UMLS CUI [4])
C0151905 (UMLS CUI [5])
C0741494 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C1314939 (UMLS CUI [7,2])
C0024299 (UMLS CUI [7,3])
HIV Infection
Item
known hiv infection. patients will not be tested routinely.
boolean
C0019693 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Protocol Compliance
Item
any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
boolean
C3840291 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
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