ID

38037

Beskrivning

Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01514565

Länk

https://clinicaltrials.gov/show/NCT01514565

Nyckelord

Versioner (1)
  1. 2019-09-10 2019-09-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01514565

Engelsk

Eligibility Breast Cancer NCT01514565

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically-confirmed triple negative invasive breast carcinoma
Beskrivning

Triple Negative Breast Neoplasm Invasive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3539878
UMLS CUI [1,2]
C0205281
any type of ductal or lobular invasive carcinoma
Beskrivning

Invasive Ductal Breast Carcinoma Type Any | Invasive Lobular Breast Carcinoma Type Any

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1134719
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C0279565
UMLS CUI [2,2]
C0332307
UMLS CUI [2,3]
C1552551
patients with or without brca-1 and brca-2 mutations are eligible to participate
Beskrivning

BRCA1 gene mutation | BRCA2 gene mutation | BRCA1 gene mutation Absent | BRCA2 gene mutation Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C1511022
UMLS CUI [2]
C1511024
UMLS CUI [3,1]
C1511022
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1511024
UMLS CUI [4,2]
C0332197
life expectancy > 6 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
pre-, peri- or postmenopausal
Beskrivning

Premenopausal state | Perimenopausal state | Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2]
C3839366
UMLS CUI [3]
C0232970
clinical stage t2-4, n0-3, m0 (stage ii-iii)
Beskrivning

TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1]
C0474926
patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial
Beskrivning

Informed Consent | Informed Consent Patient Representatives

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
adequate hematologic, renal, and liver function and functional status that permit chemotherapy administration. however, these parameters will be evaluated by the treating physician, and decisions regarding eligibility for chemotherapy or surgery will be made on a case by case scenario.
Beskrivning

Hematologic function | Renal function | Liver function | Functional Status allowing Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4,1]
C0598463
UMLS CUI [4,2]
C0683607
UMLS CUI [4,3]
C0392920
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior history of and/or active therapy for invasive breast cancer (includes chemotherapy, radiation, hormonal therapy including ais, tamoxifen, raloxifene, fulvestrant or any other antiestrogen/serm)
Beskrivning

Invasive carcinoma of breast Previous | Therapeutic procedure Invasive carcinoma of breast | Chemotherapy | Therapeutic radiology procedure | Hormone Therapy | Aromatase Inhibitors | Tamoxifen | Raloxifene | fulvestrant | Estrogen Antagonists | Selective Estrogen Receptor Modulators

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0853879
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0279025
UMLS CUI [6]
C0593802
UMLS CUI [7]
C0039286
UMLS CUI [8]
C0244404
UMLS CUI [9]
C0935916
UMLS CUI [10]
C0014930
UMLS CUI [11]
C0732611
patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered. patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered to be at less than 30% risk for relapse (by their physician).
Beskrivning

Second Primary Cancers | Exception Skin carcinoma | Exception Treatment completed Malignant Neoplasm | Exception Low Risk Relapse

Datatyp

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0580352
UMLS CUI [3,3]
C0006826
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3538919
UMLS CUI [4,3]
C0035020
only ductal/lobular carcinoma in situ but not invasive component
Beskrivning

Ductal carcinoma in situ only | Lobular carcinoma in situ only | Component In situ Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007124
UMLS CUI [1,2]
C0205171
UMLS CUI [2,1]
C0334381
UMLS CUI [2,2]
C0205171
UMLS CUI [3,1]
C1705248
UMLS CUI [3,2]
C0444498
UMLS CUI [3,3]
C0332197
any sort of confirmed metastatic disease (ajcc stage iv at diagnosis)
Beskrivning

Neoplasm Metastasis Type Any TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
UMLS CUI [1,4]
C3258246
any sort of active local radiation therapy (to the breast or the axilla), before the neoadjuvant chemotherapy
Beskrivning

Radiotherapy to breast Locally | Radiotherapy to axilla Locally | Status pre- Neoadjuvant Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948310
UMLS CUI [1,2]
C1517927
UMLS CUI [2,1]
C1997064
UMLS CUI [2,2]
C1517927
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0600558
UMLS CUI [3,3]
C3665472
pregnant or lactating, in case this precludes the subject to receive chemotherapy.
Beskrivning

Pregnancy Excludes Chemotherapy | Breast Feeding Excludes Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0392920
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0392920
impossibility to receive neoadjuvant chemotherapy due to significant medical comorbidities, allergies or performance status. this will be exclusively decided by the treating oncologists.
Beskrivning

Neoadjuvant Chemotherapy Receive Unsuccessful | Etiology Comorbidity Significant | Etiology Hypersensitivity | Etiology Performance status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C1514756
UMLS CUI [1,4]
C1272705
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0009488
UMLS CUI [2,3]
C0750502
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0020517
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C1518965
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Similar models

Eligibility Breast Cancer NCT01514565

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 18 years old
boolean
C0001779 (UMLS CUI [1])
Triple Negative Breast Neoplasm Invasive
Item
histologically-confirmed triple negative invasive breast carcinoma
boolean
C3539878 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
Invasive Ductal Breast Carcinoma Type Any | Invasive Lobular Breast Carcinoma Type Any
Item
any type of ductal or lobular invasive carcinoma
boolean
C1134719 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0279565 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
BRCA1 gene mutation | BRCA2 gene mutation | BRCA1 gene mutation Absent | BRCA2 gene mutation Absent
Item
patients with or without brca-1 and brca-2 mutations are eligible to participate
boolean
C1511022 (UMLS CUI [1])
C1511024 (UMLS CUI [2])
C1511022 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1511024 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Life Expectancy
Item
life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Premenopausal state | Perimenopausal state | Postmenopausal state
Item
pre-, peri- or postmenopausal
boolean
C0232969 (UMLS CUI [1])
C3839366 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
TNM Breast tumor staging
Item
clinical stage t2-4, n0-3, m0 (stage ii-iii)
boolean
C0474926 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representatives
Item
patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Hematologic function | Renal function | Liver function | Functional Status allowing Chemotherapy
Item
adequate hematologic, renal, and liver function and functional status that permit chemotherapy administration. however, these parameters will be evaluated by the treating physician, and decisions regarding eligibility for chemotherapy or surgery will be made on a case by case scenario.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0598463 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0392920 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Invasive carcinoma of breast Previous | Therapeutic procedure Invasive carcinoma of breast | Chemotherapy | Therapeutic radiology procedure | Hormone Therapy | Aromatase Inhibitors | Tamoxifen | Raloxifene | fulvestrant | Estrogen Antagonists | Selective Estrogen Receptor Modulators
Item
prior history of and/or active therapy for invasive breast cancer (includes chemotherapy, radiation, hormonal therapy including ais, tamoxifen, raloxifene, fulvestrant or any other antiestrogen/serm)
boolean
C0853879 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0853879 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
C0593802 (UMLS CUI [6])
C0039286 (UMLS CUI [7])
C0244404 (UMLS CUI [8])
C0935916 (UMLS CUI [9])
C0014930 (UMLS CUI [10])
C0732611 (UMLS CUI [11])
Second Primary Cancers | Exception Skin carcinoma | Exception Treatment completed Malignant Neoplasm | Exception Low Risk Relapse
Item
patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered. patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered to be at less than 30% risk for relapse (by their physician).
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0580352 (UMLS CUI [3,2])
C0006826 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C3538919 (UMLS CUI [4,2])
C0035020 (UMLS CUI [4,3])
Ductal carcinoma in situ only | Lobular carcinoma in situ only | Component In situ Absent
Item
only ductal/lobular carcinoma in situ but not invasive component
boolean
C0007124 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0334381 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C1705248 (UMLS CUI [3,1])
C0444498 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Neoplasm Metastasis Type Any TNM clinical staging
Item
any sort of confirmed metastatic disease (ajcc stage iv at diagnosis)
boolean
C0027627 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
Radiotherapy to breast Locally | Radiotherapy to axilla Locally | Status pre- Neoadjuvant Chemotherapy
Item
any sort of active local radiation therapy (to the breast or the axilla), before the neoadjuvant chemotherapy
boolean
C0948310 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C1997064 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C3665472 (UMLS CUI [3,3])
Pregnancy Excludes Chemotherapy | Breast Feeding Excludes Chemotherapy
Item
pregnant or lactating, in case this precludes the subject to receive chemotherapy.
boolean
C0032961 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0006147 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
Neoadjuvant Chemotherapy Receive Unsuccessful | Etiology Comorbidity Significant | Etiology Hypersensitivity | Etiology Performance status
Item
impossibility to receive neoadjuvant chemotherapy due to significant medical comorbidities, allergies or performance status. this will be exclusively decided by the treating oncologists.
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C1272705 (UMLS CUI [1,4])
C0015127 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C1518965 (UMLS CUI [4,2])
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