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Information:
Fel:
ID
37247
Beskrivning
A Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib; ODM derived from: https://clinicaltrials.gov/show/NCT02487316
Länk
https://clinicaltrials.gov/show/NCT02487316
Nyckelord
Versioner (2)
- 2019-07-11 2019-07-11 -
- 2019-07-11 2019-07-11 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
11 juli 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Eligibility Systemic Anaplastic Large-Cell Lymphoma NCT02487316
Eligibility Systemic Anaplastic Large-Cell Lymphoma NCT02487316
- StudyEvent: Eligibility
Similar models
Eligibility Systemic Anaplastic Large-Cell Lymphoma NCT02487316
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
ALK positive large B-cell lymphoma Primary Biopsy | Therapy Absent
Item
primary alk(+) system diffuse large b-cell lymphoma histologically confirmed by biopsy without therapy
boolean
C1333294 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0205225 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
ECOG performance status
Item
ecog 0-2
boolean
C1520224 (UMLS CUI [1])
Measurable lesion Quantity | Measurable lesion Major Axis | Measurable lesion Minor Axis
Item
more than 1 measurable lesions with major axis >1.5cm and minor axis>1.0cm
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1295723 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C1295724 (UMLS CUI [3,2])
C1265611 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1295723 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C1295724 (UMLS CUI [3,2])
Survival time Estimated
Item
estimated survival >/3months
boolean
C2919552 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
C0750572 (UMLS CUI [1,2])
Age
Item
age 18-65 years
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Gender Contraceptive methods
Item
women of childbearing age should have a negative pregnancy test; men and women who need to agree to use effective contraception during the period of treatment and the following 1 years
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0427780 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
signature of informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
age <\ 18years
boolean
C0001779 (UMLS CUI [1])
ALK positive large B-cell lymphoma Absent
Item
without alk(+) system diffuse large b-cell lymphoma histologically confirmed by biopsy
boolean
C1333294 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
Measurable lesion Absent
Item
without measurable lesions
boolean
C1513041 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs
Item
being treated by other drugs in other clinical trials
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0013230 (UMLS CUI [2])
Pregnancy Contraceptive methods Unwilling | Breast Feeding Contraceptive methods Unwilling
Item
pregnant or lactating women, who are not willing to take contraceptive measures during the study period, or are not willing to use effective contraceptive measures during the period of treatment and the following 1 years
boolean
C0032961 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0006147 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0006147 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Hepatic Insufficiency | SERUM TOTAL BILIRUBIN ELEVATED | Alanine aminotransferase increased
Item
hepatic insufficiency: serum total bilirubin, alt more than 2 times higher than normal
boolean
C1306571 (UMLS CUI [1])
C0595866 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0595866 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Renal Insufficiency | Serum creatinine raised
Item
renal insufficiency: more than 2 times higher than that of normal serum creatinine
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
C0700225 (UMLS CUI [2])
Blood Screening | White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement
Item
blood screening period: wbc < 1 * 109/l * 109/l; platelet < 25; hb < 60g/l
boolean
C1511226 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
HIV Seropositivity
Item
hiv test positive
boolean
C0019699 (UMLS CUI [1])