ID

22425

Beschreibung

Bortezomib and CHOP in Patients With Advanced Stage Aggressive T Cell or Natural Killer (NK)/T Cell Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT00374699

Link

https://clinicaltrials.gov/show/NCT00374699

Stichworte

Versionen (1)
  1. 02.06.17 02.06.17 -
Hochgeladen am

2. Juni 2017

DOI

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Creative Commons BY 4.0
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Eligibility Peripheral T-Cell Lymphomas NCT00374699

Englisch

Eligibility Peripheral T-Cell Lymphomas NCT00374699

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed ptcls and nk/t cell lymphomas excluding anaplastic lymphoma kinase (alk)-positive anaplastic large cell t-cell lymphomas (alcl)
Beschreibung

Peripheral T-Cell Lymphoma | Lymphoma, Extranodal NK-T-Cell | Anaplastic large T-cell lymphoma Anaplastic lymphoma kinase Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0079774
UMLS CUI [2]
C1955906
UMLS CUI [3,1]
C1275317
UMLS CUI [3,2]
C0252409
UMLS CUI [3,3]
C1514241
performance status (ecog) ≤ 3
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
age ≤ 65
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
at least one or more unidimensionally measurable lesion(s)
Beschreibung

Measurable Disease Linear Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
≥ 2 cm by conventional computed tomography (ct)
Beschreibung

Lesion size X-Ray Computed Tomography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449453
UMLS CUI [1,2]
C0040405
≥ 1 cm by spiral ct
Beschreibung

Lesion size Spiral Computed Tomography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449453
UMLS CUI [1,2]
C0860888
skin lesion (photographs should be taken)
Beschreibung

Skin lesion Photograph

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037284
UMLS CUI [1,2]
C0441468
measurable lesion by physical examination
Beschreibung

Measurable Disease Physical Examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0031809
laboratory values
Beschreibung

Laboratory Results

Datentyp

boolean

Alias
UMLS CUI [1]
C1254595
creatinine (cr) < 1.5 mg% or creatinine clearance (ccr) > 50 ml/min
Beschreibung

Creatinine measurement, serum | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
transaminase < 3 x upper normal value
Beschreibung

Transaminases

Datentyp

boolean

Alias
UMLS CUI [1]
C0002594
bilirubin < 2.0 mg/dl
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
absolute neutrophil count (anc) > 1,500/ul
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
platelets > 75,000/ul
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
ann arbor stage iii or iv
Beschreibung

Ann Arbor lymphoma staging system

Datentyp

boolean

Alias
UMLS CUI [1]
C0432516
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other malignancies within the past 5 years except basal cell skin cancer or carcinoma in situ (cis) of the cervix
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0851140
serious comorbid diseases
Beschreibung

Comorbidity Serious

Datentyp

boolean

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

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any waiver of these inclusion and exclusion criteria must be approved by the investigator and the sponsor on a case-by-case basis prior to enrolling the subject. this must be documented by both the sponsor and the investigator. no subject will be allowed to enroll in this study more than once.
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Peripheral T-Cell Lymphomas NCT00374699

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Peripheral T-Cell Lymphoma | Lymphoma, Extranodal NK-T-Cell | Anaplastic large T-cell lymphoma Anaplastic lymphoma kinase Positive
Item
histologically confirmed ptcls and nk/t cell lymphomas excluding anaplastic lymphoma kinase (alk)-positive anaplastic large cell t-cell lymphomas (alcl)
boolean
C0079774 (UMLS CUI [1])
C1955906 (UMLS CUI [2])
C1275317 (UMLS CUI [3,1])
C0252409 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
ECOG performance status
Item
performance status (ecog) ≤ 3
boolean
C1520224 (UMLS CUI [1])
Age
Item
age ≤ 65
boolean
C0001779 (UMLS CUI [1])
Measurable Disease Linear Quantity
Item
at least one or more unidimensionally measurable lesion(s)
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Lesion size X-Ray Computed Tomography
Item
≥ 2 cm by conventional computed tomography (ct)
boolean
C0449453 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
Lesion size Spiral Computed Tomography
Item
≥ 1 cm by spiral ct
boolean
C0449453 (UMLS CUI [1,1])
C0860888 (UMLS CUI [1,2])
Skin lesion Photograph
Item
skin lesion (photographs should be taken)
boolean
C0037284 (UMLS CUI [1,1])
C0441468 (UMLS CUI [1,2])
Measurable Disease Physical Examination
Item
measurable lesion by physical examination
boolean
C1513041 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Laboratory Results
Item
laboratory values
boolean
C1254595 (UMLS CUI [1])
Creatinine measurement, serum | Creatinine clearance measurement
Item
creatinine (cr) < 1.5 mg% or creatinine clearance (ccr) > 50 ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Transaminases
Item
transaminase < 3 x upper normal value
boolean
C0002594 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin < 2.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) > 1,500/ul
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets > 75,000/ul
boolean
C0032181 (UMLS CUI [1])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Ann Arbor lymphoma staging system
Item
ann arbor stage iii or iv
boolean
C0432516 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
any other malignancies within the past 5 years except basal cell skin cancer or carcinoma in situ (cis) of the cervix
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Comorbidity Serious
Item
serious comorbid 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])
Study Subject Participation Status
Item
any waiver of these inclusion and exclusion criteria must be approved by the investigator and the sponsor on a case-by-case basis prior to enrolling the subject. this must be documented by both the sponsor and the investigator. no subject will be allowed to enroll in this study more than once.
boolean
C2348568 (UMLS CUI [1])
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