ID

31015

Beschreibung

Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00431210

Link

https://clinicaltrials.gov/show/NCT00431210

Stichworte

Versionen (1)
  1. 10.07.18 10.07.18 -
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See clinicaltrials.gov

Hochgeladen am

10. Juli 2018

DOI

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Eligibility Nasopharyngeal Carcinoma NCT00431210

Englisch

Eligibility Nasopharyngeal Carcinoma NCT00431210

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically proven npc of any who grade, associated with ebv documented by the presence of eber by in situ hybridization in the tumor. this must be confirmed by pathology review at brigham and women's hospital.
Beschreibung

Nasopharyngeal carcinoma WHO tumor classification | Epstein-Barr Virus Associated | EBER Present In Situ Hybridization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C1301142
UMLS CUI [2,1]
C0014644
UMLS CUI [2,2]
C0332281
UMLS CUI [3,1]
C3830308
UMLS CUI [3,2]
C0150312
UMLS CUI [3,3]
C0162788
incurable npc as defined by: relapsed or progressive disease after initial treatment with no potentially curative option; npc with metastasis
Beschreibung

Nasopharyngeal carcinoma incurable | Recurrent disease | Progressive Disease | Therapeutic procedure Initial | Curative treatment Lacking | Metastatic malignant neoplasm to nasopharynx

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C0175969
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1335499
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0205265
UMLS CUI [5,1]
C1273390
UMLS CUI [5,2]
C0332268
UMLS CUI [6]
C1334731
recovery from toxicity from any prior npc therapy to grade 1 or better (ctcace v.3.0)
Beschreibung

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

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 [2,1]
C0600688
UMLS CUI [2,2]
C1516728
UMLS CUI [3]
C1115804
18 years of age or older
Beschreibung

Age

Datentyp

boolean

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

Evaluable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1516986
ecog performance status of 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, liver and renal function
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
acute hepatitis, known hiv, or other condition that requires immunosuppressive therapy, including current use of systemic corticosteroids
Beschreibung

Hepatitis | HIV Infections | Condition Requirement Therapeutic immunosuppression | CORTICOSTEROIDS FOR SYSTEMIC USE

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]
C3653708
autoimmune disease that is active and requires current therapy
Beschreibung

Autoimmune Disease Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0332121
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
incomplete healing from previous major surgery
Beschreibung

Healing Incomplete | Etiology Major surgery Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0043240
UMLS CUI [1,2]
C0205257
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0679637
UMLS CUI [2,3]
C0205156
significant history of uncontrolled cardiac disease
Beschreibung

Heart Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
women who have a positive b-hcg test or are breastfeeding
Beschreibung

Serum pregnancy test (B-HCG) Positive | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430060
UMLS CUI [1,2]
C1514241
UMLS CUI [2]
C0006147
any concurrent chemotherapy or other concurrent investigational agent not part of this study
Beschreibung

Chemotherapy Except for Study Protocol | Investigational New Drugs Except for Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C2348563
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C2348563
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Ähnliche Modelle

Eligibility Nasopharyngeal Carcinoma NCT00431210

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Nasopharyngeal carcinoma WHO tumor classification | Epstein-Barr Virus Associated | EBER Present In Situ Hybridization
Item
histologically or cytologically proven npc of any who grade, associated with ebv documented by the presence of eber by in situ hybridization in the tumor. this must be confirmed by pathology review at brigham and women's hospital.
boolean
C2931822 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
C0014644 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C3830308 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
C0162788 (UMLS CUI [3,3])
Nasopharyngeal carcinoma incurable | Recurrent disease | Progressive Disease | Therapeutic procedure Initial | Curative treatment Lacking | Metastatic malignant neoplasm to nasopharynx
Item
incurable npc as defined by: relapsed or progressive disease after initial treatment with no potentially curative option; npc with metastasis
boolean
C2931822 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
C1335499 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0205265 (UMLS CUI [4,2])
C1273390 (UMLS CUI [5,1])
C0332268 (UMLS CUI [5,2])
C1334731 (UMLS CUI [6])
Toxicity Due to Prior Therapy Nasopharyngeal carcinoma | Toxicity CTCAE Grades | Patient recovered
Item
recovery from toxicity from any prior npc therapy to grade 1 or better (ctcace v.3.0)
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C2931822 (UMLS CUI [1,4])
C0600688 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C1115804 (UMLS CUI [3])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Evaluable Disease
Item
evaluable disease, according to recist
boolean
C1516986 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver and renal function
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 Infections | Condition Requirement Therapeutic immunosuppression | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
acute hepatitis, known hiv, or other condition that requires immunosuppressive therapy, including current use of 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])
Autoimmune Disease Treatment required for
Item
autoimmune disease that is active and requires current therapy
boolean
C0004364 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
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])
Healing Incomplete | Etiology Major surgery Previous
Item
incomplete healing from previous major surgery
boolean
C0043240 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0679637 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
Heart Disease Uncontrolled
Item
significant history of uncontrolled cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Serum pregnancy test (B-HCG) Positive | Breast Feeding
Item
women who have a positive b-hcg test or are breastfeeding
boolean
C0430060 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
Chemotherapy Except for Study Protocol | Investigational New Drugs Except for Study Protocol
Item
any concurrent chemotherapy or other concurrent investigational agent not part of this study
boolean
C0392920 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
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