ID

37899

Description

Lung Inflammation and Lung Metastases From Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01182519

Link

https://clinicaltrials.gov/show/NCT01182519

Keywords

Versions (1)
  1. 8/29/19 8/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 29, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01182519

English

Eligibility Breast Cancer NCT01182519

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
registered patient at mskcc
Description

Patient Enrollment

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1516879
histologically proven breast cancer. it is not necessary that pathology be reviewed at mskcc
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
age ≥18 years group 1 (a and b)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with metastatic breast cancer on biopsy or imaging study.
Description

Secondary malignant neoplasm of female breast Biopsy | Secondary malignant neoplasm of female breast Imaging study

Data type

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C1881134
patients will be considered to have lung metastases, and will be assigned to group 1a if any of the following criteria are met, otherwise patients will be assigned to group 1b "no known lung metastases," biopsy-proven lung metastasis.
Description

Secondary malignant neoplasm of lung | Secondary malignant neoplasm of lung not known

Data type

boolean

Alias
UMLS CUI [1]
C0153676
UMLS CUI [2,1]
C0153676
UMLS CUI [2,2]
C0439673
pleural effusion with cytologic evidence of malignancy.
Description

Pleural effusion | Malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0032227
UMLS CUI [2]
C0006826
pleural effusion, exudative in character, without alternative explanation and attributed, in the opinion of the clinician to metastatic disease.
Description

Pleural effusion Exudative | Attribution Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C0311438
UMLS CUI [2,1]
C0596130
UMLS CUI [2,2]
C0027627
symptoms attributable to lung metastases and a radiological pattern interpreted by a radiologist as suspicious for metastatic disease.
Description

Symptoms Secondary malignant neoplasm of lung | Pattern Radiologic | Suspicion Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0153676
UMLS CUI [2,1]
C0449774
UMLS CUI [2,2]
C0205483
UMLS CUI [3,1]
C0242114
UMLS CUI [3,2]
C0027627
any pulmonary nodule on chest radiograph, ct scan, pet-ct or mri, which is interpreted by the clinician and radiologist to be metastatic in etiology, whether or not a biopsy was performed, and regardless of symptoms.
Description

Lung nodule Chest radiography | Lung nodule CT scan | Lung nodule PET scan | Lung nodule MRI | Etiology metastatic | Independent of Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0034079
UMLS CUI [1,2]
C0039985
UMLS CUI [2,1]
C0034079
UMLS CUI [2,2]
C0040405
UMLS CUI [3,1]
C0034079
UMLS CUI [3,2]
C0032743
UMLS CUI [4,1]
C0034079
UMLS CUI [4,2]
C0024485
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C1522484
UMLS CUI [6,1]
C0332291
UMLS CUI [6,2]
C1457887
a radiographic pattern interpreted by a radiologist as consistent with lymphangitic carcinomatosis.
Description

Pattern Radiographic | Consistent with Lymphangitis carcinomatosa

Data type

boolean

Alias
UMLS CUI [1,1]
C0449774
UMLS CUI [1,2]
C0444708
UMLS CUI [2,1]
C0332290
UMLS CUI [2,2]
C0238258
group 2 (controls)
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
history of early breast cancer and currently no evidence of disease
Description

Early-Stage Breast Carcinoma | Disease Free of

Data type

boolean

Alias
UMLS CUI [1]
C2986665
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to provide written informed consent.
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
inability to complete smoking and nsaid questionnaire.
Description

Smoking Questionnaire Completion Unable | NSAID Questionnaire Completion Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0037369
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0034394
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C1299582
steroid use within the previous 4 weeks.
Description

Steroid use

Data type

boolean

Alias
UMLS CUI [1]
C0281991
radiotherapy to the breast, chest wall or axilla within the previous 3 months.
Description

Radiotherapy to breast | Radiotherapy to chest wall | Radiotherapy to axilla

Data type

boolean

Alias
UMLS CUI [1]
C0948310
UMLS CUI [2]
C1998066
UMLS CUI [3]
C1997064
men with breast cancer.
Description

Gender | Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
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Similar models

Eligibility Breast Cancer NCT01182519

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patient Enrollment
Item
registered patient at mskcc
boolean
C0030705 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
Breast Carcinoma
Item
histologically proven breast cancer. it is not necessary that pathology be reviewed at mskcc
boolean
C0678222 (UMLS CUI [1])
Age
Item
age ≥18 years group 1 (a and b)
boolean
C0001779 (UMLS CUI [1])
Secondary malignant neoplasm of female breast Biopsy | Secondary malignant neoplasm of female breast Imaging study
Item
diagnosed with metastatic breast cancer on biopsy or imaging study.
boolean
C0346993 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2,1])
C1881134 (UMLS CUI [2,2])
Secondary malignant neoplasm of lung | Secondary malignant neoplasm of lung not known
Item
patients will be considered to have lung metastases, and will be assigned to group 1a if any of the following criteria are met, otherwise patients will be assigned to group 1b "no known lung metastases," biopsy-proven lung metastasis.
boolean
C0153676 (UMLS CUI [1])
C0153676 (UMLS CUI [2,1])
C0439673 (UMLS CUI [2,2])
Pleural effusion | Malignancy
Item
pleural effusion with cytologic evidence of malignancy.
boolean
C0032227 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Pleural effusion Exudative | Attribution Neoplasm Metastasis
Item
pleural effusion, exudative in character, without alternative explanation and attributed, in the opinion of the clinician to metastatic disease.
boolean
C0032227 (UMLS CUI [1,1])
C0311438 (UMLS CUI [1,2])
C0596130 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Symptoms Secondary malignant neoplasm of lung | Pattern Radiologic | Suspicion Neoplasm Metastasis
Item
symptoms attributable to lung metastases and a radiological pattern interpreted by a radiologist as suspicious for metastatic disease.
boolean
C1457887 (UMLS CUI [1,1])
C0153676 (UMLS CUI [1,2])
C0449774 (UMLS CUI [2,1])
C0205483 (UMLS CUI [2,2])
C0242114 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
Lung nodule Chest radiography | Lung nodule CT scan | Lung nodule PET scan | Lung nodule MRI | Etiology metastatic | Independent of Symptoms
Item
any pulmonary nodule on chest radiograph, ct scan, pet-ct or mri, which is interpreted by the clinician and radiologist to be metastatic in etiology, whether or not a biopsy was performed, and regardless of symptoms.
boolean
C0034079 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0034079 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0034079 (UMLS CUI [3,1])
C0032743 (UMLS CUI [3,2])
C0034079 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C1522484 (UMLS CUI [5,2])
C0332291 (UMLS CUI [6,1])
C1457887 (UMLS CUI [6,2])
Pattern Radiographic | Consistent with Lymphangitis carcinomatosa
Item
a radiographic pattern interpreted by a radiologist as consistent with lymphangitic carcinomatosis.
boolean
C0449774 (UMLS CUI [1,1])
C0444708 (UMLS CUI [1,2])
C0332290 (UMLS CUI [2,1])
C0238258 (UMLS CUI [2,2])
Control Group
Item
group 2 (controls)
boolean
C0009932 (UMLS CUI [1])
Early-Stage Breast Carcinoma | Disease Free of
Item
history of early breast cancer and currently no evidence of disease
boolean
C2986665 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
inability to provide written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Smoking Questionnaire Completion Unable | NSAID Questionnaire Completion Unable
Item
inability to complete smoking and nsaid questionnaire.
boolean
C0037369 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0003211 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
Steroid use
Item
steroid use within the previous 4 weeks.
boolean
C0281991 (UMLS CUI [1])
Radiotherapy to breast | Radiotherapy to chest wall | Radiotherapy to axilla
Item
radiotherapy to the breast, chest wall or axilla within the previous 3 months.
boolean
C0948310 (UMLS CUI [1])
C1998066 (UMLS CUI [2])
C1997064 (UMLS CUI [3])
Gender | Breast Carcinoma
Item
men with breast cancer.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
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