ID

37912

Beschrijving

The Growth Factor Signature (GFS) as an Intermediate Biomarker of Response for Development of PI3K-Pathway Inhibitors in Patients With Breast Cancer (MK-8669-050); ODM derived from: https://clinicaltrials.gov/show/NCT01220570

Link

https://clinicaltrials.gov/show/NCT01220570

Trefwoorden

Versies (1)
  1. 30-08-19 30-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

30 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01220570

Engels

Eligibility Breast Cancer NCT01220570

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant has operable stage i-iiia invasive breast cancer of the following subtype: er-positive, her2-negative tumor with histologic grade 2 or 3 and ki67 ≥ 15%
Beschrijving

Invasive carcinoma of breast Operable TNM Breast tumor staging | Tumor Estrogen receptor positive | Tumor HER2 Negative | Tumor Histologic Grade | Tumor Ki67 Measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205188
UMLS CUI [1,3]
C0474926
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0279754
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C2348908
UMLS CUI [4,1]
C0027651
UMLS CUI [4,2]
C0919553
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C4049944
tumor is at least 2 cm in diameter as assessed by physical or radiographic exam
Beschrijving

Tumor Diameter Physical Examination | Tumor Diameter Diagnostic radiologic examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0031809
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0043299
participant consents to provide an existing tissue sample or to have a core needle biopsy before drug administration
Beschrijving

Availability of Tissue specimen | Core needle biopsy | Status pre- Administration of medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C1292533
UMLS CUI [2]
C1318309
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C3469597
participant consents to provide tissue samples following drug administration by a second core needle biopsy or from a surgical specimen
Beschrijving

Availability of Tissue specimen | Status post Administration of medication | Core needle biopsy second | Surgical specimen

Datatype

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C1292533
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C3469597
UMLS CUI [3,1]
C1318309
UMLS CUI [3,2]
C0205436
UMLS CUI [4]
C1647891
participant must have adequate organ function
Beschrijving

Organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant has received any prior chemotherapy, biological therapy or radiotherapy for breast cancer
Beschrijving

Prior Chemotherapy Breast Carcinoma | Biological treatment Breast Carcinoma | Prior radiation therapy Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0678222
participant has a known hypersensitivity to the components of study drugs or their analogs, including hypersensitivity to macrolide antibiotics (e.g. clarithromycin, erythromycin, azithromycin).
Beschrijving

Hypersensitivity Investigational New Drugs Component | Hypersensitivity Investigational New Drugs Analogs | Allergy to macrolide antibiotic | Clarithromycin allergy | Allergy to erythromycin | Azithromycin allergy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0243071
UMLS CUI [3]
C0571383
UMLS CUI [4]
C0571384
UMLS CUI [5]
C0014808
UMLS CUI [6]
C0571385
participant has poorly controlled diabetes mellitus, or requires insulin for glucose control.
Beschrijving

Poorly controlled diabetes mellitus | Insulin administration required for glucose control

Datatype

boolean

Alias
UMLS CUI [1]
C0554876
UMLS CUI [2]
C4227726
participant is unable to swallow capsules and/or absorb oral medications
Beschrijving

Lacking Able to swallow Capsules | Lacking Able to swallow Oral medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0006935
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2712086
UMLS CUI [2,3]
C0175795
participant is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study.
Beschrijving

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
participant is known to be human immunodeficiency virus (hiv)-positive
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
participant has known history of active hepatitis b or c.
Beschrijving

Hepatitis B | Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
participant is concurrently using growth hormone (gh) or growth hormone inhibitors
Beschrijving

Growth Hormone | Growth Hormone Receptor Antagonist

Datatype

boolean

Alias
UMLS CUI [1]
C0037663
UMLS CUI [2]
C1947982
participant has significant or uncontrolled cardiovascular disease, including heart failure, unstable angina, or a myocardial infarction within the last 6 months
Beschrijving

Cardiovascular Disease | Cardiovascular Disease Uncontrolled | Heart failure | Angina, Unstable | Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0027051
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Similar models

Eligibility Breast Cancer NCT01220570

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Operable TNM Breast tumor staging | Tumor Estrogen receptor positive | Tumor HER2 Negative | Tumor Histologic Grade | Tumor Ki67 Measurement
Item
participant has operable stage i-iiia invasive breast cancer of the following subtype: er-positive, her2-negative tumor with histologic grade 2 or 3 and ki67 ≥ 15%
boolean
C0853879 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0279754 (UMLS CUI [2,2])
C0027651 (UMLS CUI [3,1])
C2348908 (UMLS CUI [3,2])
C0027651 (UMLS CUI [4,1])
C0919553 (UMLS CUI [4,2])
C0027651 (UMLS CUI [5,1])
C4049944 (UMLS CUI [5,2])
Tumor Diameter Physical Examination | Tumor Diameter Diagnostic radiologic examination
Item
tumor is at least 2 cm in diameter as assessed by physical or radiographic exam
boolean
C0027651 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0043299 (UMLS CUI [2,3])
Availability of Tissue specimen | Core needle biopsy | Status pre- Administration of medication
Item
participant consents to provide an existing tissue sample or to have a core needle biopsy before drug administration
boolean
C0470187 (UMLS CUI [1,1])
C1292533 (UMLS CUI [1,2])
C1318309 (UMLS CUI [2])
C0332152 (UMLS CUI [3,1])
C3469597 (UMLS CUI [3,2])
Availability of Tissue specimen | Status post Administration of medication | Core needle biopsy second | Surgical specimen
Item
participant consents to provide tissue samples following drug administration by a second core needle biopsy or from a surgical specimen
boolean
C0470187 (UMLS CUI [1,1])
C1292533 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C3469597 (UMLS CUI [2,2])
C1318309 (UMLS CUI [3,1])
C0205436 (UMLS CUI [3,2])
C1647891 (UMLS CUI [4])
Organ function
Item
participant must have adequate organ function
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Breast Carcinoma | Biological treatment Breast Carcinoma | Prior radiation therapy Breast Carcinoma
Item
participant has received any prior chemotherapy, biological therapy or radiotherapy for breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
Hypersensitivity Investigational New Drugs Component | Hypersensitivity Investigational New Drugs Analogs | Allergy to macrolide antibiotic | Clarithromycin allergy | Allergy to erythromycin | Azithromycin allergy
Item
participant has a known hypersensitivity to the components of study drugs or their analogs, including hypersensitivity to macrolide antibiotics (e.g. clarithromycin, erythromycin, azithromycin).
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0243071 (UMLS CUI [2,3])
C0571383 (UMLS CUI [3])
C0571384 (UMLS CUI [4])
C0014808 (UMLS CUI [5])
C0571385 (UMLS CUI [6])
Poorly controlled diabetes mellitus | Insulin administration required for glucose control
Item
participant has poorly controlled diabetes mellitus, or requires insulin for glucose control.
boolean
C0554876 (UMLS CUI [1])
C4227726 (UMLS CUI [2])
Lacking Able to swallow Capsules | Lacking Able to swallow Oral medication
Item
participant is unable to swallow capsules and/or absorb oral medications
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C2712086 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
participant is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
HIV Seropositivity
Item
participant is known to be human immunodeficiency virus (hiv)-positive
boolean
C0019699 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
participant has known history of active hepatitis b or c.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Growth Hormone | Growth Hormone Receptor Antagonist
Item
participant is concurrently using growth hormone (gh) or growth hormone inhibitors
boolean
C0037663 (UMLS CUI [1])
C1947982 (UMLS CUI [2])
Cardiovascular Disease | Cardiovascular Disease Uncontrolled | Heart failure | Angina, Unstable | Myocardial Infarction
Item
participant has significant or uncontrolled cardiovascular disease, including heart failure, unstable angina, or a myocardial infarction within the last 6 months
boolean
C0007222 (UMLS CUI [1])
C0007222 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018801 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
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