ID

44298

Beskrivning

Individualized Therapy Based of Tumoral mRNA Levels of ERCC1, RRM1 and BRCA1 in Advanced Non-Small-Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00705549

Länk

https://clinicaltrials.gov/show/NCT00705549

Nyckelord

Versioner (2)
  1. 2018-07-28 2018-07-28 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-Small-Cell Lung Cancer NCT00705549

Engelsk

Eligibility Non-Small-Cell Lung Cancer NCT00705549

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically proven stage iv and stage iii (with malignant pleural or pericardial effusion) squamous or adenocarcinoma carcinomas of the lung
Beskrivning

Squamous cell carcinoma of lung TNM clinical staging | Adenocarcinoma of lung TNM clinical staging | Pleural Effusion, Malignant | Malignant pericardial effusion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149782
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0152013
UMLS CUI [2,2]
C3258246
UMLS CUI [3]
C0080032
UMLS CUI [4]
C0220655
adequate formalin fixed paraffin embedded tumor sample provided for molecular analysis
Beskrivning

Tumor tissue sample Formalin-fixed paraffin-embedded Molecular Analysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C2711483
UMLS CUI [1,3]
C1513380
no previous anticancer treatment for metastatic/advanced disease. patients who received prior adjuvant chemotherapy are eligible if they have remained free of disease for at least 6 months after the completion of adjuvant therapy.
Beskrivning

Cancer treatment Absent Neoplasm Metastasis | Cancer treatment Absent Advanced disease | Adjuvant Chemotherapy Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0027627
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0679246
UMLS CUI [3,1]
C0085533
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
age above 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
performance status (ecog) 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy >= 3 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
effective contraception for both male and female subjects if the risk of conception exists
Beskrivning

Risk Conception Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0009637
UMLS CUI [1,3]
C0700589
adequate hematologic parameters (absolute neutrophil count >= 1.5x109/l and platelets >= 100x109/l), creatinine (gfr>= 60ml/min) and total bilirubin < 1.5 times the upper limit of normal; aspartate and alanine aminotransferase < 2,5 times the upper limit of normal
Beskrivning

Parameters Hematologic | Absolute neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Glomerular Filtration Rate | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449381
UMLS CUI [1,2]
C0205488
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0017654
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0201899
UMLS CUI [8]
C0201836
all patients will have to sign written informed consent in order to participate in the study
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with non-squamous tumors who have no contradiction for administration of bevacizumab
Beskrivning

Non-Squamous Non-Small Cell Lung Carcinoma | Medical contraindication Absent bevacizumab

Datatyp

boolean

Alias
UMLS CUI [1]
C4324656
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0796392
active infection or malnutrition (loss of more than 20% of the body weight)
Beskrivning

Communicable Disease | Malnutrition | Weight decreased Percentage

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0162429
UMLS CUI [3,1]
C1262477
UMLS CUI [3,2]
C0439165
known hypersensitivity reaction to any of the component of the treatment
Beskrivning

Allergic Reaction Component Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0087111
concurrent or previous chronic systemic immune therapy
Beskrivning

Immunotherapy Systemic chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0205191
pregnancy (absence to be confirmed by ß-hcg test) or lactation period
Beskrivning

Pregnancy | Breast Feeding | Pregnancy Absent Serum Beta-HCG Test

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C1255526
known alcohol/drug abuse
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
legal incapacity or limited legal capacity
Beskrivning

Legal capacity Lacking | Legal capacity Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0439801
medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
Beskrivning

Medical condition Preventing Patient Completion of clinical trial | Mental condition Preventing Patient Completion of clinical trial | Medical condition Preventing Informed Consent | Mental condition Preventing Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0030705
UMLS CUI [1,4]
C2732579
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0030705
UMLS CUI [2,4]
C2732579
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0021430
a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma
Beskrivning

Primary tumor second | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0205436
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
previous radiotherapy to the target lesions. patients treated with palliative radiotherapy had to have measurable metastatic disease outside the irradiation fields
Beskrivning

Prior radiation therapy Target Lesion | Palliative course of radiotherapy | Neoplasm Metastasis Measurable outside Radiation Field

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C2986546
UMLS CUI [2]
C0475092
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C1513040
UMLS CUI [3,3]
C0205101
UMLS CUI [3,4]
C1882536
patients with severe cardiac dysfunction, unstable angina petrosis, or high risk of uncontrolled arrhythmia
Beskrivning

Cardiac dysfunction Severe | Angina, Unstable | High risk of Cardiac Arrhythmia Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3277906
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0002965
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0003811
UMLS CUI [3,3]
C0205318
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Similar models

Eligibility Non-Small-Cell Lung Cancer NCT00705549

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of lung TNM clinical staging | Adenocarcinoma of lung TNM clinical staging | Pleural Effusion, Malignant | Malignant pericardial effusion
Item
patients with histologically proven stage iv and stage iii (with malignant pleural or pericardial effusion) squamous or adenocarcinoma carcinomas of the lung
boolean
C0149782 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0152013 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0080032 (UMLS CUI [3])
C0220655 (UMLS CUI [4])
Tumor tissue sample Formalin-fixed paraffin-embedded Molecular Analysis
Item
adequate formalin fixed paraffin embedded tumor sample provided for molecular analysis
boolean
C0475358 (UMLS CUI [1,1])
C2711483 (UMLS CUI [1,2])
C1513380 (UMLS CUI [1,3])
Cancer treatment Absent Neoplasm Metastasis | Cancer treatment Absent Advanced disease | Adjuvant Chemotherapy Disease Free of
Item
no previous anticancer treatment for metastatic/advanced disease. patients who received prior adjuvant chemotherapy are eligible if they have remained free of disease for at least 6 months after the completion of adjuvant therapy.
boolean
C0920425 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0920425 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0679246 (UMLS CUI [2,3])
C0085533 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
Age
Item
age above 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
performance status (ecog) 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy >= 3 months
boolean
C0023671 (UMLS CUI [1])
Risk Conception Contraceptive methods
Item
effective contraception for both male and female subjects if the risk of conception exists
boolean
C0035647 (UMLS CUI [1,1])
C0009637 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Parameters Hematologic | Absolute neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Glomerular Filtration Rate | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
adequate hematologic parameters (absolute neutrophil count >= 1.5x109/l and platelets >= 100x109/l), creatinine (gfr>= 60ml/min) and total bilirubin < 1.5 times the upper limit of normal; aspartate and alanine aminotransferase < 2,5 times the upper limit of normal
boolean
C0449381 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0017654 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
Informed Consent
Item
all patients will have to sign written informed consent in order to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Non-Squamous Non-Small Cell Lung Carcinoma | Medical contraindication Absent bevacizumab
Item
patients with non-squamous tumors who have no contradiction for administration of bevacizumab
boolean
C4324656 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0796392 (UMLS CUI [2,3])
Communicable Disease | Malnutrition | Weight decreased Percentage
Item
active infection or malnutrition (loss of more than 20% of the body weight)
boolean
C0009450 (UMLS CUI [1])
C0162429 (UMLS CUI [2])
C1262477 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Allergic Reaction Component Therapeutic procedure
Item
known hypersensitivity reaction to any of the component of the treatment
boolean
C1527304 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Immunotherapy Systemic chronic
Item
concurrent or previous chronic systemic immune therapy
boolean
C0021083 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy Absent Serum Beta-HCG Test
Item
pregnancy (absence to be confirmed by ß-hcg test) or lactation period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1255526 (UMLS CUI [3,3])
Substance Use Disorders
Item
known alcohol/drug abuse
boolean
C0038586 (UMLS CUI [1])
Legal capacity Lacking | Legal capacity Limited
Item
legal incapacity or limited legal capacity
boolean
C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Medical condition Preventing Patient Completion of clinical trial | Mental condition Preventing Patient Completion of clinical trial | Medical condition Preventing Informed Consent | Mental condition Preventing Informed Consent
Item
medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C2732579 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
Primary tumor second | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma
boolean
C0677930 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Prior radiation therapy Target Lesion | Palliative course of radiotherapy | Neoplasm Metastasis Measurable outside Radiation Field
Item
previous radiotherapy to the target lesions. patients treated with palliative radiotherapy had to have measurable metastatic disease outside the irradiation fields
boolean
C0279134 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0475092 (UMLS CUI [2])
C0027627 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0205101 (UMLS CUI [3,3])
C1882536 (UMLS CUI [3,4])
Cardiac dysfunction Severe | Angina, Unstable | High risk of Cardiac Arrhythmia Uncontrolled
Item
patients with severe cardiac dysfunction, unstable angina petrosis, or high risk of uncontrolled arrhythmia
boolean
C3277906 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0332167 (UMLS CUI [3,1])
C0003811 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
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