ID

38428

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01909752

Keywords

  1. 17/10/19 17/10/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

17 ottobre 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Carcinoma, Non-Small-Cell Lung NCT01909752

Eligibility Carcinoma, Non-Small-Cell Lung NCT01909752

Inclusion Criteria
Descrizione

Inclusion Criteria

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

Non-Small Cell Lung Carcinoma TNM clinical staging

Tipo di dati

boolean

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

Definitive Treatment Completed

Tipo di dati

boolean

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

Enrollment | Elapsed Time Definitive Treatment Completion

Tipo di dati

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
Descrizione

Toxicity Due to Definitive Treatment | Resolution CTCAE Grades

Tipo di dati

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
Descrizione

ECOG performance status

Tipo di dati

boolean

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

Childbearing Potential Pregnancy test negative

Tipo di dati

boolean

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

Agreement Preventing Pregnancy | Agreement Preventing Reproduction

Tipo di dati

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
Descrizione

Informed Consent | Protocol Compliance

Tipo di dati

boolean

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

Life Expectancy Minimum

Tipo di dati

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
Descrizione

Prior Therapy Completed Investigational New Drugs

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Availability of Tumor tissue sample

Tipo di dati

boolean

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

Exclusion Criteria

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

Autoimmune Diseases | Exception Vitiligo | Exception Hypothyroidism

Tipo di dati

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
Descrizione

Cancer Other

Tipo di dati

boolean

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

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Tipo di dati

boolean

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

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

Tipo di dati

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
Descrizione

Chemotherapy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0392920

Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01909752

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial