Eligibility Breast Cancer NCT01996267

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StudyEvent: Eligibility
1. Eligibility Breast Cancer NCT01996267

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Invasive carcinoma of breast

Item

histologically confirmed infiltrating breast cancer

boolean

C0853879 (UMLS CUI [1])

Disease TNM Breast tumor staging | Lymph nodal status Ultrasonography | Lymph nodal status Fine needle aspiration biopsy | Lymph nodal status Sentinel Lymph Node Biopsy | Lymph nodal status FDG-PET Scanning

Item

stage ii or stage iii disease. nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or fdg-pet scan.

boolean

C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0449927 (UMLS CUI [2,1])
C0041618 (UMLS CUI [2,2])
C0449927 (UMLS CUI [3,1])
C1510483 (UMLS CUI [3,2])
C0449927 (UMLS CUI [4,1])
C0796693 (UMLS CUI [4,2])
C0449927 (UMLS CUI [5,1])
C3899175 (UMLS CUI [5,2])

HER2 Overexpression | HER2 gene amplification | Component Invasive Core needle biopsy

Item

overexpression and/or amplification of her2 in an invasive component of the core biopsy, according to one of the following definitions:

boolean

C0069515 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2])
C1705248 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
C1318309 (UMLS CUI [3,3])

Neoplastic Cell Invasive Percentage | Tissue membrane Circumferential Complete Staining | Score

Item

•>30% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)

boolean

C0597032 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0025255 (UMLS CUI [2,1])
C0205113 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C1704680 (UMLS CUI [2,4])
C0449820 (UMLS CUI [3])

HER2 gene amplification | Gene copy number In Situ Hybridization

Item

•her2 gene amplification defined as >6 her2 gene copies per nucleus by in situ hybridization.

boolean

C1512127 (UMLS CUI [1])
C0178655 (UMLS CUI [2,1])
C0162788 (UMLS CUI [2,2])

Age

Item

age ≥18

boolean

C0001779 (UMLS CUI [1])

ECOG performance status

Item

eastern cooperative oncology group performance status ≤1

boolean

C1520224 (UMLS CUI [1])

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Item

adequate bone marrow function (anc >1.5 x 109/l, platelets >100 x 109/l)

boolean

C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])

Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement

Item

adequate hepatic function (alat, asat and bilirubin <2.5 times upper limit of normal)

boolean

C0232741 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C1278039 (UMLS CUI [4])

Renal function | Creatinine measurement, serum

Item

adequate renal function (creatinine clearance >50 ml/min)

boolean

C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan

Item

lvef ≥50% measured by echocardiography or muga

boolean

C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])

Absence Mental condition Interferes with Protocol Compliance | Absence Factor Familial Interferes with Protocol Compliance | Absence Sociological Factors Interfere with Protocol Compliance | Absence Geographic Factors Interfere with Protocol Compliance | Absence Mental condition Interferes with Follow-up | Absence Factor Familial Interferes with Follow-up | Absence Sociological Factors Interfere with Follow-up | Absence Geographic Factors Interfere with Follow-up

Item

absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

boolean

C0332197 (UMLS CUI [1,1])
C3840291 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C1521761 (UMLS CUI [2,2])
C0241888 (UMLS CUI [2,3])
C0521102 (UMLS CUI [2,4])
C0525058 (UMLS CUI [2,5])
C0332197 (UMLS CUI [3,1])
C3850138 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C0017444 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
C0332197 (UMLS CUI [5,1])
C3840291 (UMLS CUI [5,2])
C0521102 (UMLS CUI [5,3])
C3274571 (UMLS CUI [5,4])
C0332197 (UMLS CUI [6,1])
C1521761 (UMLS CUI [6,2])
C0241888 (UMLS CUI [6,3])
C0521102 (UMLS CUI [6,4])
C3274571 (UMLS CUI [6,5])
C0332197 (UMLS CUI [7,1])
C3850138 (UMLS CUI [7,2])
C0521102 (UMLS CUI [7,3])
C3274571 (UMLS CUI [7,4])
C0332197 (UMLS CUI [8,1])
C0017444 (UMLS CUI [8,2])
C0521102 (UMLS CUI [8,3])
C3274571 (UMLS CUI [8,4])

Absence Medical condition Patient At risk

Item

absence of any medical condition that would place the patient at unusual risk.

boolean

C0332197 (UMLS CUI [1,1])
C3843040 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])

Informed Consent

Item

signed written informed consent

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Prior radiation therapy | Prior Chemotherapy

Item

previous radiation therapy or chemotherapy

boolean

C0279134 (UMLS CUI [1])
C1514457 (UMLS CUI [2])

Cancer Other | Exception Carcinoma in Situ | Exception Curative treatment Cancer Other | Chemotherapy Absent | Therapeutic radiology procedure Absent

Item

other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.

boolean

C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007099 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C1707251 (UMLS CUI [3,3])
C0392920 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1522449 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

Item

current pregnancy or breastfeeding. women of childbearing potential must use adequate contraceptive protection

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])

Distant metastasis Chest X-ray | Distant metastasis Ultrasonography of liver | Distant metastasis Radioisotope scan of bone | Distant metastasis CT of chest and abdomen | Distant metastasis FDG-PET Scanning

Item

evidence of distant metastases. evaluation of the presence of distant metastases may include chest x-ray, liver ultrasound, isotope bone-scan, ct-scan of chest and abdomen and/or fdg-pet scan, according to local procedures.

boolean

C1269798 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C1269798 (UMLS CUI [2,1])
C0412534 (UMLS CUI [2,2])
C1269798 (UMLS CUI [3,1])
C0203668 (UMLS CUI [3,2])
C1269798 (UMLS CUI [4,1])
C1630402 (UMLS CUI [4,2])
C1269798 (UMLS CUI [5,1])
C3899175 (UMLS CUI [5,2])

Invasive carcinoma of breast Bilateral Mammography | Invasive carcinoma of breast Bilateral Mammary Ultrasonography | Invasive carcinoma of breast Bilateral MRI of breast

Item

evidence of bilateral infiltrating breast cancer. evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or mri breast.

boolean

C0853879 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0024671 (UMLS CUI [1,3])
C0853879 (UMLS CUI [2,1])
C0238767 (UMLS CUI [2,2])
C0080264 (UMLS CUI [2,3])
C0853879 (UMLS CUI [3,1])
C0238767 (UMLS CUI [3,2])
C0344104 (UMLS CUI [3,3])

Cancer treatment | Investigational New Drugs

Item

concurrent anti-cancer treatment or another investigational drug.

boolean

C0920425 (UMLS CUI [1])
C0013230 (UMLS CUI [2])

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Eligibility Breast Cancer NCT01996267