Eligibility Breast Cancer NCT01514565

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StudyEvent: Eligibility
1. Eligibility Breast Cancer NCT01514565

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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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Eligibility Breast Cancer NCT01514565