ID

43044

Beschreibung

Trial of E10A in Head and Neck Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00634595

Link

https://clinicaltrials.gov/show/NCT00634595

Stichworte

Versionen (2)
  1. 24.03.18 24.03.18 -
  2. 17.09.21 17.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

17. September 2021

DOI

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Eligibility Head and Neck Squamous Carcinoma NCT00634595

Englisch

Eligibility Head and Neck Squamous Carcinoma NCT00634595

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed recurrent or metastatic head and neck squamous carcinoma or nasopharyngeal carcinoma
Beschreibung

HEAD NECK CANCER SQUAMOUS CELL RECURRENT | HEAD NECK CANCER SQUAMOUS CELL METASTATIC | Nasopharyngeal carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C4524839
UMLS CUI [2]
C0744620
UMLS CUI [3]
C2931822
the tumor was amenable to direct injection and measurement ( > 2 cm)
Beschreibung

Neoplasm Amenable Injection | Neoplasm Amenable Measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C1533685
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C0242485
an eastern cooperative oncology group (ecog) performance status of 0 to 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
a life expectancy over three months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
the absence of serious medical or psychiatric disorders
Beschreibung

Disease Serious Absent | Mental disorders Serious Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0332197
serum creatinine < 1.5 mg/dl; wbc count >3,000/mm3, platelet count > 80,000/mm3, hemoglobin > 8 g/dl; total bilirubin value < 1.5 times the upper limit of normal [uln], alt level < 2.5 times uln, ast < 2.5 times uln.
Beschreibung

Creatinine measurement, serum | White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201899
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
a history of brain metastases or a primary brain tumor
Beschreibung

Metastatic malignant neoplasm to brain | Brain Tumor, Primary

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0750974
a history of hemorrhagic diathesis
Beschreibung

Bleeding tendency

Datentyp

boolean

Alias
UMLS CUI [1]
C1458140
a history of corticosteroids or immunosuppressives use within four weeks of study entry
Beschreibung

Adrenal Cortex Hormones | Immunosuppressive Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0021081
a history of immune deficiency disorder or organ transplant
Beschreibung

Immunologic Deficiency Syndromes | Organ Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C0029216
has evidence of active adenovirus infection or uncontrolled infection
Beschreibung

Adenovirus Infection | Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C0001486
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
received any chemotherapy or radiotherapy within four weeks of study entry
Beschreibung

Chemotherapy | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
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Ähnliche Modelle

Eligibility Head and Neck Squamous Carcinoma NCT00634595

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
HEAD NECK CANCER SQUAMOUS CELL RECURRENT | HEAD NECK CANCER SQUAMOUS CELL METASTATIC | Nasopharyngeal carcinoma
Item
histologically or cytologically confirmed recurrent or metastatic head and neck squamous carcinoma or nasopharyngeal carcinoma
boolean
C4524839 (UMLS CUI [1])
C0744620 (UMLS CUI [2])
C2931822 (UMLS CUI [3])
Neoplasm Amenable Injection | Neoplasm Amenable Measurement
Item
the tumor was amenable to direct injection and measurement ( > 2 cm)
boolean
C0027651 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C1533685 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])
ECOG performance status
Item
an eastern cooperative oncology group (ecog) performance status of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
a life expectancy over three months
boolean
C0023671 (UMLS CUI [1])
Disease Serious Absent | Mental disorders Serious Absent
Item
the absence of serious medical or psychiatric disorders
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Creatinine measurement, serum | White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
serum creatinine < 1.5 mg/dl; wbc count >3,000/mm3, platelet count > 80,000/mm3, hemoglobin > 8 g/dl; total bilirubin value < 1.5 times the upper limit of normal [uln], alt level < 2.5 times uln, ast < 2.5 times uln.
boolean
C0201976 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Metastatic malignant neoplasm to brain | Brain Tumor, Primary
Item
a history of brain metastases or a primary brain tumor
boolean
C0220650 (UMLS CUI [1])
C0750974 (UMLS CUI [2])
Bleeding tendency
Item
a history of hemorrhagic diathesis
boolean
C1458140 (UMLS CUI [1])
Adrenal Cortex Hormones | Immunosuppressive Agents
Item
a history of corticosteroids or immunosuppressives use within four weeks of study entry
boolean
C0001617 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
Immunologic Deficiency Syndromes | Organ Transplantation
Item
a history of immune deficiency disorder or organ transplant
boolean
C0021051 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
Adenovirus Infection | Communicable Disease Uncontrolled
Item
has evidence of active adenovirus infection or uncontrolled infection
boolean
C0001486 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Chemotherapy | Therapeutic radiology procedure
Item
received any chemotherapy or radiotherapy within four weeks of study entry
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
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