ID

23475

Description

Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer (NSCLC) Stages IIIB/IV; ODM derived from: https://clinicaltrials.gov/show/NCT00516685

Lien

https://clinicaltrials.gov/show/NCT00516685

Mots-clés

  1. 06/07/2017 06/07/2017 -
Téléchargé le

6 juillet 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV NCT00516685

Eligibility Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV NCT00516685

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who have signed the informed consent form.
Description

ID.1

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
patients who are eighteen years of age or over with histologically or cytologically confirmed nsclc in advanced stages iiib or iv, not amenable to any attempt of curative chemo-radiotherapy and/or surgery.
Description

ID.2

Type de données

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0877373
patients with measurable lesions, defined as those measurable at least in one dimension (refered to higher diameter) and with a diameter equal or higher 20 mm using conventional techniques (pet, ct scan, mri, rx) or equal or higher 10 mm using ct scan.
Description

ID.3

Type de données

boolean

Alias
UMLS CUI [1]
C0221198
patients who have finished their last cycle of chemotherapy and/or radiotherapy not less than 4 weeks prior to randomization and not more than 8 weeks.
Description

ID.4

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1522449
female patients of reproductive potential must have negative pregnancy tests. those female volunteers admitted to the study must be using a reliable means of contraception such as tubal ligation, oral contraceptive or iud.
Description

ID.5

Type de données

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0009862
ecog status 0 to 2.
Description

ID.6

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
patients with normal organ and bone marrow function, as defined by the parameters in accordance to that provided by the normal lab reference range.
Description

ID.7

Type de données

boolean

Alias
UMLS CUI [1]
C0678852
patients with no evidence of objective disease progression, 1 month after finishing first line chemotherapy as per recist.
Description

ID.8

Type de données

boolean

Alias
UMLS CUI [1]
C0242656
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are candidates for combined modality treatment.
Description

ID.9

Type de données

boolean

Alias
UMLS CUI [1]
C0009429
patients who are receiving immunosuppressive therapy including corticosteroids.
Description

ID.10

Type de données

boolean

Alias
UMLS CUI [1]
C0021081
patients who have received immunotherapy within the previous 3 months.
Description

ID.11

Type de données

boolean

Alias
UMLS CUI [1]
C0021081
patients who have participated in a clinical study within the previous 30 days.
Description

ID.12

Type de données

boolean

Alias
UMLS CUI [1]
C0008976
patients who may be allergic to any component of the vaccine.
Description

ID.13

Type de données

boolean

Alias
UMLS CUI [1]
C0020517
medical reasons considered by the investigators as disqualification from the study such as significant uncontrolled co-morbid disease or potential non-compliance with the protocol.
Description

ID.14

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1321605
patients bearing brain metastasis from the primary lung tumor.
Description

ID.15

Type de données

boolean

Alias
UMLS CUI [1]
C0220650
patients bearing a second primary tumor.
Description

ID.16

Type de données

boolean

Alias
UMLS CUI [1]
C0677930
patients showing progressive disease after finishing first line chemotherapy.
Description

ID.17

Type de données

boolean

Alias
UMLS CUI [1]
C0677932

Similar models

Eligibility Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV NCT00516685

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
patients who have signed the informed consent form.
boolean
C0021430 (UMLS CUI [1])
ID.2
Item
patients who are eighteen years of age or over with histologically or cytologically confirmed nsclc in advanced stages iiib or iv, not amenable to any attempt of curative chemo-radiotherapy and/or surgery.
boolean
C0001779 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0877373 (UMLS CUI [1,3])
ID.3
Item
patients with measurable lesions, defined as those measurable at least in one dimension (refered to higher diameter) and with a diameter equal or higher 20 mm using conventional techniques (pet, ct scan, mri, rx) or equal or higher 10 mm using ct scan.
boolean
C0221198 (UMLS CUI [1])
ID.4
Item
patients who have finished their last cycle of chemotherapy and/or radiotherapy not less than 4 weeks prior to randomization and not more than 8 weeks.
boolean
C0392920 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
ID.5
Item
female patients of reproductive potential must have negative pregnancy tests. those female volunteers admitted to the study must be using a reliable means of contraception such as tubal ligation, oral contraceptive or iud.
boolean
C0032961 (UMLS CUI [1,1])
C0009862 (UMLS CUI [1,2])
ID.6
Item
ecog status 0 to 2.
boolean
C1520224 (UMLS CUI [1])
ID.7
Item
patients with normal organ and bone marrow function, as defined by the parameters in accordance to that provided by the normal lab reference range.
boolean
C0678852 (UMLS CUI [1])
ID.8
Item
patients with no evidence of objective disease progression, 1 month after finishing first line chemotherapy as per recist.
boolean
C0242656 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.9
Item
patients who are candidates for combined modality treatment.
boolean
C0009429 (UMLS CUI [1])
ID.10
Item
patients who are receiving immunosuppressive therapy including corticosteroids.
boolean
C0021081 (UMLS CUI [1])
ID.11
Item
patients who have received immunotherapy within the previous 3 months.
boolean
C0021081 (UMLS CUI [1])
ID.12
Item
patients who have participated in a clinical study within the previous 30 days.
boolean
C0008976 (UMLS CUI [1])
ID.13
Item
patients who may be allergic to any component of the vaccine.
boolean
C0020517 (UMLS CUI [1])
ID.14
Item
medical reasons considered by the investigators as disqualification from the study such as significant uncontrolled co-morbid disease or potential non-compliance with the protocol.
boolean
C0012634 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
ID.15
Item
patients bearing brain metastasis from the primary lung tumor.
boolean
C0220650 (UMLS CUI [1])
ID.16
Item
patients bearing a second primary tumor.
boolean
C0677930 (UMLS CUI [1])
ID.17
Item
patients showing progressive disease after finishing first line chemotherapy.
boolean
C0677932 (UMLS CUI [1])

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