ID

27410

Beskrivning

VATS Lobectomy for Clinical Stage IB or II Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00425022

Länk

https://clinicaltrials.gov/show/NCT00425022

Nyckelord

Versioner (1)
  1. 2017-11-13 2017-11-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 november 2017

DOI

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Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00425022

Engelsk

Eligibility Carcinoma, Non-Small-Cell Lung NCT00425022

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologic or cytologic diagnosis of non-small cell lung cancer.
Beskrivning

Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
2. clinical stage ib or ii, according to the american joint committee on cancer (ajcc).
Beskrivning

TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1]
C3258246
3. tumor ≤ 6 cm in size amenable to surgical resection.
Beskrivning

Tumor size Amenable Excision

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0728940
4. including clinical ib or ii nsclc after neoadjuvant therapy
Beskrivning

Neoadjuvant Therapy | Non-Small Cell Lung Carcinoma TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1]
C0600558
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C3258246
5. performance status of 0-1 on ecog scale.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
6. at least 18 years old.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
7. patient compliance that allows adequate follow-up.
Beskrivning

Compliance behavior Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
8. medical fitness of patients adequate for radical nsclc surgery.
Beskrivning

Physical Fitness | Operative Surgical Procedures Radical Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0031812
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0439807
UMLS CUI [2,3]
C0007131
9. adequate organ function including the following:adequate hematologic function: wbc count ³ 4,000/ul, absolute neutrophil count (anc) ³ 1,500/ul, platelet count ³
Beskrivning

Organ function | Hematologic function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0221130
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0032181
100,000/ul, and hemoglobin ³ 10 gm/dl.adequate hepatic function: bilirubin £ 1.5 x unl, alt or ast £ 2.5 x unl.adequate renal function: creatinine £ 1.5mg/dl.
Beskrivning

Hemoglobin measurement | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0232741
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0232804
UMLS CUI [7]
C0201976
10. signed informed consent from patient or legal representative.
Beskrivning

Informed Consent | Informed Consent Patient Representatives

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
11. patients with reproductive potential must use an approved contraceptive method during and for 3 months after the study. females with childbearing potential must have a negative urine hcg test within 7 days prior to study enrollment.
Beskrivning

Reproductive potential Contraceptive methods | Childbearing Potential Urine human chorionic gonadotropin negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C1112196
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. metastatic disease in workup
Beskrivning

Neoplasm Metastasis | Work up

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2]
C0750430
2. any t3, t4 lesion or n2, n3 lesion
Beskrivning

Lesion TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C3258246
3. concurrent administration of other tumor therapy, including radiotherapy, immunotherapy except chemotherapy.
Beskrivning

Cancer treatment | Therapeutic radiology procedure | Immunotherapy | Exception Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0392920
4. active uncontrolled infection.
Beskrivning

Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
5. serious concomitant disorders that would compromise the safety of patient or compromise the patient’s ability to tolerate therapy.
Beskrivning

Comorbidity Serious compromises Patient safety | Comorbidity Serious compromises Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C0087111
6. significant neurological or mental disorder.
Beskrivning

Nervous system disorder | Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
7. previous history of malignancy in any organ
Beskrivning

Malignant Neoplasm Organ Any

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C1552551
8. pregnant or nursing.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

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

Eligibility Carcinoma, Non-Small-Cell Lung NCT00425022

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
1. histologic or cytologic diagnosis of non-small cell lung cancer.
boolean
C0007131 (UMLS CUI [1])
TNM clinical staging
Item
2. clinical stage ib or ii, according to the american joint committee on cancer (ajcc).
boolean
C3258246 (UMLS CUI [1])
Tumor size Amenable Excision
Item
3. tumor ≤ 6 cm in size amenable to surgical resection.
boolean
C0475440 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
Neoadjuvant Therapy | Non-Small Cell Lung Carcinoma TNM clinical staging
Item
4. including clinical ib or ii nsclc after neoadjuvant therapy
boolean
C0600558 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
ECOG performance status
Item
5. performance status of 0-1 on ecog scale.
boolean
C1520224 (UMLS CUI [1])
Age
Item
6. at least 18 years old.
boolean
C0001779 (UMLS CUI [1])
Compliance behavior Follow-up
Item
7. patient compliance that allows adequate follow-up.
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
Physical Fitness | Operative Surgical Procedures Radical Non-Small Cell Lung Carcinoma
Item
8. medical fitness of patients adequate for radical nsclc surgery.
boolean
C0031812 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0439807 (UMLS CUI [2,2])
C0007131 (UMLS CUI [2,3])
Organ function | Hematologic function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement
Item
9. adequate organ function including the following:adequate hematologic function: wbc count ³ 4,000/ul, absolute neutrophil count (anc) ³ 1,500/ul, platelet count ³
boolean
C0678852 (UMLS CUI [1])
C0221130 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
Hemoglobin measurement | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
100,000/ul, and hemoglobin ³ 10 gm/dl.adequate hepatic function: bilirubin £ 1.5 x unl, alt or ast £ 2.5 x unl.adequate renal function: creatinine £ 1.5mg/dl.
boolean
C0518015 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0232804 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
Informed Consent | Informed Consent Patient Representatives
Item
10. signed informed consent from patient or legal representative.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Reproductive potential Contraceptive methods | Childbearing Potential Urine human chorionic gonadotropin negative
Item
11. patients with reproductive potential must use an approved contraceptive method during and for 3 months after the study. females with childbearing potential must have a negative urine hcg test within 7 days prior to study enrollment.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C1112196 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis | Work up
Item
1. metastatic disease in workup
boolean
C0027627 (UMLS CUI [1])
C0750430 (UMLS CUI [2])
Lesion TNM clinical staging
Item
2. any t3, t4 lesion or n2, n3 lesion
boolean
C0221198 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Cancer treatment | Therapeutic radiology procedure | Immunotherapy | Exception Chemotherapy
Item
3. concurrent administration of other tumor therapy, including radiotherapy, immunotherapy except chemotherapy.
boolean
C0920425 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
Communicable Disease Uncontrolled
Item
4. active uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Comorbidity Serious compromises Patient safety | Comorbidity Serious compromises Therapeutic procedure
Item
5. serious concomitant disorders that would compromise the safety of patient or compromise the patient’s ability to tolerate therapy.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
Nervous system disorder | Mental disorders
Item
6. significant neurological or mental disorder.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Malignant Neoplasm Organ Any
Item
7. previous history of malignancy in any organ
boolean
C0006826 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
8. pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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