ID

15138

Beschreibung

TGF-beta Resistant Cytotoxic T-lymphocytes in Treatment of EBV-positive Nasopharyngeal Carcinoma / RESIST-NPC; ODM derived from: https://clinicaltrials.gov/show/NCT02065362

Link

https://clinicaltrials.gov/show/NCT02065362

Stichworte

Versionen (1)
  1. 18.05.16 18.05.16 -
Hochgeladen am

18. Mai 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility EBV-positive Nasopharyngeal Carcinoma NCT02065362

Englisch

Eligibility EBV-positive Nasopharyngeal Carcinoma NCT02065362

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient must meet the following eligibility inclusion criteria at the time of procurement:
Beschreibung

Time Procurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1709695
nasopharyngeal carcinoma in first or subsequent relapse or with primary refractory disease
Beschreibung

Nasopharyngeal cancer recurrent | Nasopharyngeal carcinoma Disease Primary Refractory

Datentyp

boolean

Alias
UMLS CUI [1]
C0278952
UMLS CUI [2,1]
C2931822
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C2347678
ebv positive tumor
Beschreibung

Malignant Neoplasms Epstein-Barr virus test positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1611703
informed consent explained to, understood by and signed by patient/guardian. patient/guardian given copy of informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
the patient must meet the following eligibility criteria to be included for treatment:
Beschreibung

Inclusion criteria Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0087111
nasopharyngeal carcinoma in first or subsequent relapse or with primary refractory disease
Beschreibung

Nasopharyngeal cancer recurrent | Nasopharyngeal carcinoma Disease Primary Refractory

Datentyp

boolean

Alias
UMLS CUI [1]
C0278952
UMLS CUI [2,1]
C2931822
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C2347678
ebv positive tumor
Beschreibung

Malignant Neoplasms Epstein-Barr virus test positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1611703
patients with life expectancy greater than or equal to 6 weeks
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
bilirubin less than or equal to 3x upper limit of normal
Beschreibung

Bilirubin, total measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201913
ast less than or equal to 5x upper limit of normal
Beschreibung

Aspartate aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
hgb > 8.0g/dl (can be transfused)
Beschreibung

Hemoglobin | Transfusion (procedure)

Datentyp

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C1879316
creatinine less than or equal to 2x upper limit of normal for age
Beschreibung

Creatinine measurement, serum | Upper Limit of Normal Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2,1]
C1519815
UMLS CUI [2,2]
C0001779
pulse oximetry of > 90% on room air
Beschreibung

Pulse Oximetry on room air

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034108
UMLS CUI [1,2]
C2709070
off investigational therapy for 4 weeks prior to study entry
Beschreibung

Off Investigational Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518543
UMLS CUI [1,2]
C0949266
karnofsky or lansky score of greater than or equal to 50%
Beschreibung

Karnofsky Performance Status | Lansky Play-Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1522275
sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. the male partner should use a condom.
Beschreibung

Patients Sexually active | Contraceptive methods | Condoms, Male

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0241028
UMLS CUI [2]
C0700589
UMLS CUI [3]
C0009653
informed consent explained to, understood by and signed by patient/guardian. patient/guardian given copy of informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
at time of procurement:
Beschreibung

Time Procurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1709695
•known hiv positivity
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
at time of treatment:
Beschreibung

Time Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0087111
pregnant or lactating
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
severe intercurrent infection
Beschreibung

Intercurrent infection Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0240021
UMLS CUI [1,2]
C0205082
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Ähnliche Modelle

Eligibility EBV-positive Nasopharyngeal Carcinoma NCT02065362

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Time Procurement
Item
the patient must meet the following eligibility inclusion criteria at the time of procurement:
boolean
C0040223 (UMLS CUI [1,1])
C1709695 (UMLS CUI [1,2])
Nasopharyngeal cancer recurrent | Nasopharyngeal carcinoma Disease Primary Refractory
Item
nasopharyngeal carcinoma in first or subsequent relapse or with primary refractory disease
boolean
C0278952 (UMLS CUI [1])
C2931822 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C2347678 (UMLS CUI [2,3])
Malignant Neoplasms Epstein-Barr virus test positive
Item
ebv positive tumor
boolean
C0006826 (UMLS CUI [1,1])
C1611703 (UMLS CUI [1,2])
Informed Consent
Item
informed consent explained to, understood by and signed by patient/guardian. patient/guardian given copy of informed consent
boolean
C0021430 (UMLS CUI [1])
Inclusion criteria Therapeutic procedure
Item
the patient must meet the following eligibility criteria to be included for treatment:
boolean
C1512693 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Nasopharyngeal cancer recurrent | Nasopharyngeal carcinoma Disease Primary Refractory
Item
nasopharyngeal carcinoma in first or subsequent relapse or with primary refractory disease
boolean
C0278952 (UMLS CUI [1])
C2931822 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C2347678 (UMLS CUI [2,3])
Malignant Neoplasms Epstein-Barr virus test positive
Item
ebv positive tumor
boolean
C0006826 (UMLS CUI [1,1])
C1611703 (UMLS CUI [1,2])
Life Expectancy
Item
patients with life expectancy greater than or equal to 6 weeks
boolean
C0023671 (UMLS CUI [1])
Bilirubin, total measurement
Item
bilirubin less than or equal to 3x upper limit of normal
boolean
C0201913 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
ast less than or equal to 5x upper limit of normal
boolean
C0201899 (UMLS CUI [1])
Hemoglobin | Transfusion (procedure)
Item
hgb > 8.0g/dl (can be transfused)
boolean
C0019046 (UMLS CUI [1])
C1879316 (UMLS CUI [2])
Creatinine measurement, serum | Upper Limit of Normal Age
Item
creatinine less than or equal to 2x upper limit of normal for age
boolean
C0201976 (UMLS CUI [1])
C1519815 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
Pulse Oximetry on room air
Item
pulse oximetry of > 90% on room air
boolean
C0034108 (UMLS CUI [1,1])
C2709070 (UMLS CUI [1,2])
Off Investigational Therapy
Item
off investigational therapy for 4 weeks prior to study entry
boolean
C1518543 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
Karnofsky Performance Status | Lansky Play-Performance Status
Item
karnofsky or lansky score of greater than or equal to 50%
boolean
C0206065 (UMLS CUI [1])
C1522275 (UMLS CUI [2])
Patients Sexually active | Contraceptive methods | Condoms, Male
Item
sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. the male partner should use a condom.
boolean
C0030705 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2])
C0009653 (UMLS CUI [3])
Informed Consent
Item
informed consent explained to, understood by and signed by patient/guardian. patient/guardian given copy of informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Time Procurement
Item
at time of procurement:
boolean
C0040223 (UMLS CUI [1,1])
C1709695 (UMLS CUI [1,2])
HIV Seropositivity
Item
•known hiv positivity
boolean
C0019699 (UMLS CUI [1])
Time Therapeutic procedure
Item
at time of treatment:
boolean
C0040223 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Intercurrent infection Severe
Item
severe intercurrent infection
boolean
C0240021 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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