ID

38428

Beschreibung

Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01909752

Link

https://clinicaltrials.gov/show/NCT01909752

Stichworte

Versionen (1)
  1. 17.10.19 17.10.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

17. Oktober 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT01909752

Englisch

Eligibility Carcinoma, Non-Small-Cell Lung NCT01909752

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage iiia or iiib histologically proven non-small cell lung cancer
Beschreibung

Non-Small Cell Lung Carcinoma TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
completion of definitive therapy
Beschreibung

Definitive Treatment Completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986592
UMLS CUI [1,2]
C0205197
enrollment from 28 days to 12 weeks from completion of definitive therapy
Beschreibung

Enrollment | Elapsed Time Definitive Treatment Completion

Datentyp

boolean

Alias
UMLS CUI [1]
C1516879
UMLS CUI [2,1]
C2826303
UMLS CUI [2,2]
C2986592
UMLS CUI [2,3]
C0205197
toxicities from definitive therapy resolved to less than grade 1
Beschreibung

Toxicity Due to Definitive Treatment | Resolution CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C2986592
UMLS CUI [2,1]
C1514893
UMLS CUI [2,2]
C1516728
ecog performance status 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
negative pregnancy test in women of childbearing potential
Beschreibung

Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
agree to avoid pregnancy or fathering a child while on study treatment
Beschreibung

Agreement Preventing Pregnancy | Agreement Preventing Reproduction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0032961
UMLS CUI [2,1]
C0680240
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0035150
ability to give informed consent and comply with protocol
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
anticipated survival minimum of 6 months
Beschreibung

Life Expectancy Minimum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C1524031
prior therapy with investigational agents must be completed at least 3 weeks prior to study enrollment
Beschreibung

Prior Therapy Completed Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0013230
normal organ and marrow function as defined by specific lab tests
Beschreibung

Organ function Determined by Laboratory Procedures | Bone Marrow function Determined by Laboratory Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0521095
UMLS CUI [1,3]
C0022885
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [2,3]
C0521095
UMLS CUI [2,4]
C0022885
archived tumor tissue available
Beschreibung

Availability of Tumor tissue sample

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
active autoimmune disease except for vitilogo or hypothyroidism
Beschreibung

Autoimmune Diseases | Exception Vitiligo | Exception Hypothyroidism

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0042900
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0020676
active other malignancy
Beschreibung

Cancer Other

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
known hiv+ and/or hepatitis b or c positive
Beschreibung

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
medical or psychiatric conditions that would preclude safe participation
Beschreibung

Medical condition Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
ongoing chemotherapy
Beschreibung

Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
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Ähnliche Modelle

Eligibility Carcinoma, Non-Small-Cell Lung NCT01909752

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
stage iiia or iiib histologically proven non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Definitive Treatment Completed
Item
completion of definitive therapy
boolean
C2986592 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Enrollment | Elapsed Time Definitive Treatment Completion
Item
enrollment from 28 days to 12 weeks from completion of definitive therapy
boolean
C1516879 (UMLS CUI [1])
C2826303 (UMLS CUI [2,1])
C2986592 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Toxicity Due to Definitive Treatment | Resolution CTCAE Grades
Item
toxicities from definitive therapy resolved to less than grade 1
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C2986592 (UMLS CUI [1,3])
C1514893 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
negative pregnancy test in women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Agreement Preventing Pregnancy | Agreement Preventing Reproduction
Item
agree to avoid pregnancy or fathering a child while on study treatment
boolean
C0680240 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0680240 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0035150 (UMLS CUI [2,3])
Informed Consent | Protocol Compliance
Item
ability to give informed consent and comply with protocol
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Life Expectancy Minimum
Item
anticipated survival minimum of 6 months
boolean
C0023671 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Prior Therapy Completed Investigational New Drugs
Item
prior therapy with investigational agents must be completed at least 3 weeks prior to study enrollment
boolean
C1514463 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Organ function Determined by Laboratory Procedures | Bone Marrow function Determined by Laboratory Procedures
Item
normal organ and marrow function as defined by specific lab tests
boolean
C0678852 (UMLS CUI [1,1])
C0521095 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0521095 (UMLS CUI [2,3])
C0022885 (UMLS CUI [2,4])
Availability of Tumor tissue sample
Item
archived tumor tissue available
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Autoimmune Diseases | Exception Vitiligo | Exception Hypothyroidism
Item
active autoimmune disease except for vitilogo or hypothyroidism
boolean
C0004364 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0042900 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0020676 (UMLS CUI [3,2])
Cancer Other
Item
active other malignancy
boolean
C1707251 (UMLS CUI [1])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
known hiv+ and/or hepatitis b or c positive
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Medical condition Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded
Item
medical or psychiatric conditions that would preclude safe participation
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Chemotherapy
Item
ongoing chemotherapy
boolean
C0392920 (UMLS CUI [1])
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