ID

22065

Description

Study of NOV-002 in Combination With Chemotherapy to Treat Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00347412

Link

https://clinicaltrials.gov/show/NCT00347412

Keywords

Versions (1)
  1. 5/17/17 5/17/17 -
Uploaded on

May 17, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00347412

English

Eligibility Non Small Cell Lung Cancer NCT00347412

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of stage iiib with malignant pleural or pericardial effusion or stage iv (american joint committee on cancer [ajcc]) nsclc
Description

Non-Small Cell Lung Carcinoma TNM clinical staging | Pleural Effusion, Malignant | Malignant pericardial effusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0080032
UMLS CUI [3]
C0220655
ecog performance score of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, hepatic, and renal function
Description

Bone Marrow function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
new york heart association (nyha) score 1-2
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
life expectancy of at least 12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
women of child-bearing potential and men whose partners are of child-bearing potential must be willing to use an acceptable method of birth control during trial participation or are surgically sterile or women who are post-menopausal (defined as not having a menstrual cycle for greater than two years).
Description

Childbearing Potential Contraceptive methods | Gender Partner Childbearing Potential Contraceptive methods | Female Sterilization | Male sterilization | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C3831118
UMLS CUI [2,4]
C0700589
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0024559
UMLS CUI [5]
C0232970
the patient or patient's legal representative has the ability to understand the requirements of the trial, has provided written informed consent, and agrees to abide by the trial restrictions and to return for the required assessments.
Description

Informed Consent | Informed Consent Patient Representatives | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
UMLS CUI [3]
C0525058
the patient must be able to self administer daily subcutaneous injections or his/her caregiver must be able to administer daily subcutaneous injections.
Description

Subcutaneous Injections Daily Self Administration | Subcutaneous Injections Daily Administration Caregiver

Data type

boolean

Alias
UMLS CUI [1,1]
C0021499
UMLS CUI [1,2]
C0332173
UMLS CUI [1,3]
C0036589
UMLS CUI [2,1]
C0021499
UMLS CUI [2,2]
C0332173
UMLS CUI [2,3]
C1533734
UMLS CUI [2,4]
C0085537
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy for advanced nsclc or the patient has received prior neoadjuvant or adjuvant chemotherapy for nsclc in the year prior to the date of randomization
Description

Chemotherapy Non-Small Cell Lung Carcinoma Advanced | Neoadjuvant Chemotherapy Non-Small Cell Lung Carcinoma | Adjuvant Chemotherapy Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0205179
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0007131
UMLS CUI [3,1]
C0085533
UMLS CUI [3,2]
C0007131
patients with central nervous system (cns) metastases
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
any systemic disease precluding chemotherapy
Description

Systemic disease Excludes Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0392920
chronic use of systemic corticosteroids in pharmacological doses
Description

CORTICOSTEROIDS FOR SYSTEMIC USE Dose chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205191
known or history of hiv, hepatitis b virus (hbv) or hepatitis c virus (hcv) infection
Description

HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
contraindication to treatment with paclitaxel or carboplatin or any of the components of nov-002
Description

Medical contraindication Paclitaxel | Medical contraindication Carboplatin | Medical contraindication NOV 002 Component

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0144576
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0079083
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C1831919
UMLS CUI [3,3]
C1705248
any known preexisting medical condition, including substance abuse, that could interfere with the patient's participation in and completion of the protocol
Description

Medical condition Pre-existing Interferes with Study Subject Participation Status | Medical condition Pre-existing Interferes with Protocol Compliance | Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2347662
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0525058
UMLS CUI [3]
C0038586
have received any investigational drug, defined as a drug for which there is no food and drug administration (fda) approved indication, within the 30 days prior to randomization
Description

Investigational New Drugs Non-Prescription

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0013231
pregnant female or nursing mother
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Non Small Cell Lung Cancer NCT00347412

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Pleural Effusion, Malignant | Malignant pericardial effusion
Item
diagnosis of stage iiib with malignant pleural or pericardial effusion or stage iv (american joint committee on cancer [ajcc]) nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0080032 (UMLS CUI [2])
C0220655 (UMLS CUI [3])
ECOG performance status
Item
ecog performance score of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, hepatic, and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
New York Heart Association Classification
Item
new york heart association (nyha) score 1-2
boolean
C1275491 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Gender Partner Childbearing Potential Contraceptive methods | Female Sterilization | Male sterilization | Postmenopausal state
Item
women of child-bearing potential and men whose partners are of child-bearing potential must be willing to use an acceptable method of birth control during trial participation or are surgically sterile or women who are post-menopausal (defined as not having a menstrual cycle for greater than two years).
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0700589 (UMLS CUI [2,4])
C0015787 (UMLS CUI [3])
C0024559 (UMLS CUI [4])
C0232970 (UMLS CUI [5])
Informed Consent | Informed Consent Patient Representatives | Protocol Compliance
Item
the patient or patient's legal representative has the ability to understand the requirements of the trial, has provided written informed consent, and agrees to abide by the trial restrictions and to return for the required assessments.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3])
Subcutaneous Injections Daily Self Administration | Subcutaneous Injections Daily Administration Caregiver
Item
the patient must be able to self administer daily subcutaneous injections or his/her caregiver must be able to administer daily subcutaneous injections.
boolean
C0021499 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0036589 (UMLS CUI [1,3])
C0021499 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
C1533734 (UMLS CUI [2,3])
C0085537 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Non-Small Cell Lung Carcinoma Advanced | Neoadjuvant Chemotherapy Non-Small Cell Lung Carcinoma | Adjuvant Chemotherapy Non-Small Cell Lung Carcinoma
Item
prior chemotherapy for advanced nsclc or the patient has received prior neoadjuvant or adjuvant chemotherapy for nsclc in the year prior to the date of randomization
boolean
C0392920 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0007131 (UMLS CUI [2,3])
C0085533 (UMLS CUI [3,1])
C0007131 (UMLS CUI [3,2])
CNS metastases
Item
patients with central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
Systemic disease Excludes Chemotherapy
Item
any systemic disease precluding chemotherapy
boolean
C0442893 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
CORTICOSTEROIDS FOR SYSTEMIC USE Dose chronic
Item
chronic use of systemic corticosteroids in pharmacological doses
boolean
C3653708 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
HIV Infection | Hepatitis B | Hepatitis C
Item
known or history of hiv, hepatitis b virus (hbv) or hepatitis c virus (hcv) infection
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Medical contraindication Paclitaxel | Medical contraindication Carboplatin | Medical contraindication NOV 002 Component
Item
contraindication to treatment with paclitaxel or carboplatin or any of the components of nov-002
boolean
C1301624 (UMLS CUI [1,1])
C0144576 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0079083 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C1831919 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Medical condition Pre-existing Interferes with Study Subject Participation Status | Medical condition Pre-existing Interferes with Protocol Compliance | Substance Use Disorders
Item
any known preexisting medical condition, including substance abuse, that could interfere with the patient's participation in and completion of the protocol
boolean
C3843040 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C0038586 (UMLS CUI [3])
Investigational New Drugs Non-Prescription
Item
have received any investigational drug, defined as a drug for which there is no food and drug administration (fda) approved indication, within the 30 days prior to randomization
boolean
C0013230 (UMLS CUI [1,1])
C0013231 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant female or nursing mother
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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