ID

39089

Beskrivning

R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B; ODM derived from: https://clinicaltrials.gov/show/NCT01852435

Länk

https://clinicaltrials.gov/show/NCT01852435

Nyckelord

Versioner (1)
  1. 2019-11-30 2019-11-30 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 november 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diffuse Large B-cell Lymphoma NCT01852435

Engelsk

Eligibility Diffuse Large B-cell Lymphoma NCT01852435

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed de novo diffuse large b-cell lymphoma or follicular lymphoma grade 3b
Beskrivning

Diffuse Large B-Cell Lymphoma de novo | Follicular Lymphoma Ann Arbor lymphoma staging system

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C0024301
UMLS CUI [2,2]
C0432516
2. age>=16 y.o.,<=80 y.o.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. ecog < 3
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. no past history of malignancy
Beskrivning

Malignant Neoplasm Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332197
5. radiologically measurable disease, ct imaging in screening showing 2 or more clearly demarcated lesions with a largest diameter > 1.5 cm, or 1 clearly demarcated lesion with a largest diameter > 2.0 cm.
Beskrivning

Measurable Disease | Lesion Quantity CT | Lesion Longest Diameter

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0552406
6. life expectancy>6 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
7. informed consented
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. chemotherapy before
Beskrivning

Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
2. bone marrow transplantation before
Beskrivning

Bone Marrow Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0005961
3. history of malignancy
Beskrivning

Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
4. active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
Beskrivning

Communicable Disease Requirement Antibiotics General | Communicable Disease Requirement Antifungal therapy | Communicable Disease Requirement Antiviral Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003232
UMLS CUI [1,4]
C0205246
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0678026
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0280274
5. uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
Beskrivning

Cardiovascular Disease Uncontrolled | Cerebrovascular Disorder Uncontrolled | Blood Coagulation Disorder Uncontrolled | Autoimmune Disease Uncontrolled | Communicable Disease Serious Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007820
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0005779
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0004364
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0009450
UMLS CUI [5,2]
C0205404
UMLS CUI [5,3]
C0205318
6. primary cutaneous, cns, mediastinal dlbcl
Beskrivning

Primary cutaneous diffuse large cell B-cell lymphoma | Diffuse large B-cell lymphoma of central nervous system | Mediastinal (Thymic) Large B-Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1275325
UMLS CUI [2]
C2026186
UMLS CUI [3]
C1292754
7. lvef≤50%
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
8. other uncontrollable medical condition that may that may interfere the participation of the study
Beskrivning

Other medical condition Uncontrolled Interferes with Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
9. lab at enrollment(unless caused by lymphoma)
Beskrivning

Laboratory test finding | Exception Caused by Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0587081
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0024299
neutrophile<1.5*10^9/l
Beskrivning

Neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0200633
platelet<80*10^9/l
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobulin<100g/l
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
alt or ast >2*uln,akp or bilirubin >1.5*uln
Beskrivning

Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Serum bilirubin increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151849
UMLS CUI [4]
C0859062
creatinine>1.5*uln
Beskrivning

Creatinine increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151578
10. not able to comply to the protocol for mental or other unknown reasons
Beskrivning

Protocol Compliance Unable | Etiology Mental condition | Reason unknown

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C3840291
UMLS CUI [3]
C3840856
11. pregnant or lactation
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
12. active liver or biliary disease
Beskrivning

Liver disease | Biliary Tract Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0005424
13. if hbsag positive, should check hbv dna, dna positive patients cannot be enrolled. if hbsag negative but hbcab positive (whatever hbsab status), should check hbv dna,dna positive patients cannot be enrolled.
Beskrivning

HbsAg positive Hbv DNA Test | Hepatitis B DNA assay positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149709
UMLS CUI [1,2]
C1256114
UMLS CUI [2]
C1168040
14. hiv infection
Beskrivning

HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
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Similar models

Eligibility Diffuse Large B-cell Lymphoma NCT01852435

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma de novo | Follicular Lymphoma Ann Arbor lymphoma staging system
Item
1. histologically confirmed de novo diffuse large b-cell lymphoma or follicular lymphoma grade 3b
boolean
C0079744 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0024301 (UMLS CUI [2,1])
C0432516 (UMLS CUI [2,2])
Age
Item
2. age>=16 y.o.,<=80 y.o.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. ecog < 3
boolean
C1520224 (UMLS CUI [1])
Malignant Neoplasm Absent
Item
4. no past history of malignancy
boolean
C0006826 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Measurable Disease | Lesion Quantity CT | Lesion Longest Diameter
Item
5. radiologically measurable disease, ct imaging in screening showing 2 or more clearly demarcated lesions with a largest diameter > 1.5 cm, or 1 clearly demarcated lesion with a largest diameter > 2.0 cm.
boolean
C1513041 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0221198 (UMLS CUI [3,1])
C0552406 (UMLS CUI [3,2])
Life Expectancy
Item
6. life expectancy>6 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
7. informed consented
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy
Item
1. chemotherapy before
boolean
C0392920 (UMLS CUI [1])
Bone Marrow Transplantation
Item
2. bone marrow transplantation before
boolean
C0005961 (UMLS CUI [1])
Malignant Neoplasms
Item
3. history of malignancy
boolean
C0006826 (UMLS CUI [1])
Communicable Disease Requirement Antibiotics General | Communicable Disease Requirement Antifungal therapy | Communicable Disease Requirement Antiviral Therapy
Item
4. active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C0205246 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0678026 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0280274 (UMLS CUI [3,3])
Cardiovascular Disease Uncontrolled | Cerebrovascular Disorder Uncontrolled | Blood Coagulation Disorder Uncontrolled | Autoimmune Disease Uncontrolled | Communicable Disease Serious Uncontrolled
Item
5. uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007820 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0005779 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0004364 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0009450 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0205318 (UMLS CUI [5,3])
Primary cutaneous diffuse large cell B-cell lymphoma | Diffuse large B-cell lymphoma of central nervous system | Mediastinal (Thymic) Large B-Cell Lymphoma
Item
6. primary cutaneous, cns, mediastinal dlbcl
boolean
C1275325 (UMLS CUI [1])
C2026186 (UMLS CUI [2])
C1292754 (UMLS CUI [3])
Left ventricular ejection fraction
Item
7. lvef≤50%
boolean
C0428772 (UMLS CUI [1])
Other medical condition Uncontrolled Interferes with Study Subject Participation Status
Item
8. other uncontrollable medical condition that may that may interfere the participation of the study
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Laboratory test finding | Exception Caused by Lymphoma
Item
9. lab at enrollment(unless caused by lymphoma)
boolean
C0587081 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
Neutrophil count
Item
neutrophile<1.5*10^9/l
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
platelet<80*10^9/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobulin<100g/l
boolean
C0518015 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Serum bilirubin increased
Item
alt or ast >2*uln,akp or bilirubin >1.5*uln
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151849 (UMLS CUI [3])
C0859062 (UMLS CUI [4])
Creatinine increased
Item
creatinine>1.5*uln
boolean
C0151578 (UMLS CUI [1])
Protocol Compliance Unable | Etiology Mental condition | Reason unknown
Item
10. not able to comply to the protocol for mental or other unknown reasons
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C3840291 (UMLS CUI [2,2])
C3840856 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
11. pregnant or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Liver disease | Biliary Tract Disease
Item
12. active liver or biliary disease
boolean
C0023895 (UMLS CUI [1])
C0005424 (UMLS CUI [2])
HbsAg positive Hbv DNA Test | Hepatitis B DNA assay positive
Item
13. if hbsag positive, should check hbv dna, dna positive patients cannot be enrolled. if hbsag negative but hbcab positive (whatever hbsab status), should check hbv dna,dna positive patients cannot be enrolled.
boolean
C0149709 (UMLS CUI [1,1])
C1256114 (UMLS CUI [1,2])
C1168040 (UMLS CUI [2])
HIV Infection
Item
14. hiv infection
boolean
C0019693 (UMLS CUI [1])
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