ID

31019

Beschreibung

A Phase II Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00834093

Link

https://clinicaltrials.gov/show/NCT00834093

Stichworte

Versionen (1)
  1. 11.07.18 11.07.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

11. Juli 2018

DOI

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Eligibility Nasopharyngeal Carcinoma NCT00834093

Englisch

Eligibility Nasopharyngeal Carcinoma NCT00834093

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically proven npc of an who grade, associated with ebv infection documented by the presence of eber expression by in situ hybridization in the tumor. positive eber staining from another institution must be confirmed by pathology review at brigham and women's hospital. other confirmation of ebv-associated disease is acceptable, such as ebv dna in situ hybridization, if eber analysis is not adequate
Beschreibung

Nasopharyngeal carcinoma Grade WHO tumor classification | Epstein-Barr Virus Infection | Epstein-Barr Virus Early RNA Present Tumor In Situ Hybridization | Epstein-Barr Virus Early RNA Positive Staining | Disease Associated with Epstein-Barr Virus | Epstein-Barr virus DNA In Situ Hybridization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C1301142
UMLS CUI [2]
C0149678
UMLS CUI [3,1]
C3830308
UMLS CUI [3,2]
C0150312
UMLS CUI [3,3]
C0027651
UMLS CUI [3,4]
C0162788
UMLS CUI [4,1]
C4289579
UMLS CUI [4,2]
C0487602
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0332281
UMLS CUI [5,3]
C0014644
UMLS CUI [6,1]
C0369169
UMLS CUI [6,2]
C0162788
incurable npc
Beschreibung

Nasopharyngeal carcinoma incurable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C0175969
recovery from toxicity from any prior npc therapy to grade 1 or better
Beschreibung

Toxicity Due to Prior Therapy Nasopharyngeal carcinoma | Patient recovered | Toxicity CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [1,4]
C2931822
UMLS CUI [2]
C1115804
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C1516728
18 years of age or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
evaluable or measurable disease, according to modified recist
Beschreibung

Evaluable Disease | Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1516986
UMLS CUI [2]
C1513041
ecog performance status of 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, liver and renal function as outlined in protocol
Beschreibung

Bone Marrow function | Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiotherapy for primary npc within 8 weeks of enrollment, or radiotherapy for any other reason within 6 weeks
Beschreibung

Therapeutic radiology procedure Nasopharyngeal carcinoma Primary | Therapeutic radiology procedure Reason Any

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C2931822
UMLS CUI [1,3]
C0205225
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0392360
UMLS CUI [2,3]
C1552551
chemotherapy for npc within 2 weeks of enrollment
Beschreibung

Chemotherapy Nasopharyngeal carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C2931822
other cancer in the past 5 years, except for carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer
Beschreibung

Cancer Other | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of bladder | Exception Skin carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0154091
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0699893
uncontrolled central nervous system metastases
Beschreibung

CNS metastases Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
active hepatitis, known hiv, or other condition that requires immunosuppressive therapy, including current use of high dose systemic corticosteroids
Beschreibung

Hepatitis | HIV Infection | Condition Requirement Therapeutic immunosuppression | CORTICOSTEROIDS FOR SYSTEMIC USE High dose

Datentyp

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0019693
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0021079
UMLS CUI [4,1]
C3653708
UMLS CUI [4,2]
C0444956
autoimmune disease, such as systemic lupus erythematosis or rheumatoid arthritis, that is active and requires current immunosuppressive therapy
Beschreibung

Autoimmune Disease Requirement Therapeutic immunosuppression | Lupus Erythematosus, Systemic | Rheumatoid Arthritis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021079
UMLS CUI [2]
C0024141
UMLS CUI [3]
C0003873
active uncontrolled serious infection
Beschreibung

Communicable Disease Serious Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
women of child-bearing potential who have a positive pregnancy test or are breast-feeding
Beschreibung

Childbearing Potential Pregnancy test positive | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0240802
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Nasopharyngeal Carcinoma NCT00834093

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Nasopharyngeal carcinoma Grade WHO tumor classification | Epstein-Barr Virus Infection | Epstein-Barr Virus Early RNA Present Tumor In Situ Hybridization | Epstein-Barr Virus Early RNA Positive Staining | Disease Associated with Epstein-Barr Virus | Epstein-Barr virus DNA In Situ Hybridization
Item
histologically or cytologically proven npc of an who grade, associated with ebv infection documented by the presence of eber expression by in situ hybridization in the tumor. positive eber staining from another institution must be confirmed by pathology review at brigham and women's hospital. other confirmation of ebv-associated disease is acceptable, such as ebv dna in situ hybridization, if eber analysis is not adequate
boolean
C2931822 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C1301142 (UMLS CUI [1,3])
C0149678 (UMLS CUI [2])
C3830308 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
C0027651 (UMLS CUI [3,3])
C0162788 (UMLS CUI [3,4])
C4289579 (UMLS CUI [4,1])
C0487602 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0014644 (UMLS CUI [5,3])
C0369169 (UMLS CUI [6,1])
C0162788 (UMLS CUI [6,2])
Nasopharyngeal carcinoma incurable
Item
incurable npc
boolean
C2931822 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
Toxicity Due to Prior Therapy Nasopharyngeal carcinoma | Patient recovered | Toxicity CTCAE Grades
Item
recovery from toxicity from any prior npc therapy to grade 1 or better
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C2931822 (UMLS CUI [1,4])
C1115804 (UMLS CUI [2])
C0600688 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Evaluable Disease | Measurable Disease
Item
evaluable or measurable disease, according to modified recist
boolean
C1516986 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver and renal function as outlined in protocol
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure Nasopharyngeal carcinoma Primary | Therapeutic radiology procedure Reason Any
Item
radiotherapy for primary npc within 8 weeks of enrollment, or radiotherapy for any other reason within 6 weeks
boolean
C1522449 (UMLS CUI [1,1])
C2931822 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0392360 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
Chemotherapy Nasopharyngeal carcinoma
Item
chemotherapy for npc within 2 weeks of enrollment
boolean
C0392920 (UMLS CUI [1,1])
C2931822 (UMLS CUI [1,2])
Cancer Other | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of bladder | Exception Skin carcinoma
Item
other cancer in the past 5 years, except for carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0154091 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0699893 (UMLS CUI [4,2])
CNS metastases Uncontrolled
Item
uncontrolled central nervous system metastases
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Hepatitis | HIV Infection | Condition Requirement Therapeutic immunosuppression | CORTICOSTEROIDS FOR SYSTEMIC USE High dose
Item
active hepatitis, known hiv, or other condition that requires immunosuppressive therapy, including current use of high dose systemic corticosteroids
boolean
C0019158 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0021079 (UMLS CUI [3,3])
C3653708 (UMLS CUI [4,1])
C0444956 (UMLS CUI [4,2])
Autoimmune Disease Requirement Therapeutic immunosuppression | Lupus Erythematosus, Systemic | Rheumatoid Arthritis
Item
autoimmune disease, such as systemic lupus erythematosis or rheumatoid arthritis, that is active and requires current immunosuppressive therapy
boolean
C0004364 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021079 (UMLS CUI [1,3])
C0024141 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
Communicable Disease Serious Uncontrolled
Item
active uncontrolled serious infection
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Childbearing Potential Pregnancy test positive | Breast Feeding
Item
women of child-bearing potential who have a positive pregnancy test or are breast-feeding
boolean
C3831118 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
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