ID

41163

Beschrijving

Comparative Study of Neoadjuvant Chemotherapy With and Without Zometa for Management of Locally Advanced Breast Cancers; ODM derived from: https://clinicaltrials.gov/show/NCT01367288

Link

https://clinicaltrials.gov/show/NCT01367288

Trefwoorden

Versies (1)
  1. 03-07-20 03-07-20 -
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See clinicaltrials.gov

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3 juli 2020

DOI

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Licentie

Creative Commons BY-NC 4.0
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Eligibility Locally Advanced Breast Cancer NCT01367288

Engels

Eligibility Locally Advanced Breast Cancer NCT01367288

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
women 18 years of age or older
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
absence of contraindication to treatment with zometa: creatinine clearance greater than 30 ml/min (with cockroft or mdrd method).
Beschrijving

Medical contraindication Absent Zometa | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement MDRD

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0939788
UMLS CUI [2]
C2711451
UMLS CUI [3,1]
C0373595
UMLS CUI [3,2]
C3839656
breast cancer (tnm iia, iib, iiia) larger than 2cm in maximal diameter able to benefit from neoadjuvant chemotherapy
Beschrijving

Breast Carcinoma TNM Breast tumor staging | Diameter Maximal | Benefit Due to Neoadjuvant Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C1301886
UMLS CUI [2,2]
C0205289
UMLS CUI [3,1]
C0814225
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0600558
UMLS CUI [3,4]
C3665472
ductal or lobular histological type of the breast tumor
Beschrijving

Ductal Breast Carcinoma | Breast cancer, lobular

Datatype

boolean

Alias
UMLS CUI [1]
C1527349
UMLS CUI [2]
C3549742
who performance status 0-2
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
patient who understands the french language
Beschrijving

Comprehension French language

Datatype

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376246
covered by, or having the right to social security
Beschrijving

Social Security coverage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0037435
UMLS CUI [1,2]
C1551362
signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
breast cancers of rare histological type (other than ductal and lobular)
Beschrijving

Breast Carcinoma Histologic type Rare | Exception Ductal Breast Carcinoma | Exception Lobular breast cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0449574
UMLS CUI [1,3]
C0522498
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1527349
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3549742
noninvasive cancer
Beschrijving

Malignant Neoplasm Noninvasive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C2986496
multifocal tumor (more than 2 tumoral lesions or 2 tumoral lesions distant more than 2cm each other)
Beschrijving

Multifocal tumor

Datatype

boolean

Alias
UMLS CUI [1]
C1302461
t4 breast tumor
Beschrijving

Breast Carcinoma TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
presence of organ, bone, or skin metastases (in the initial staging workup)
Beschrijving

Organ Neoplasm Metastasis | Secondary malignant neoplasm of bone | Secondary malignant neoplasm of skin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0027627
UMLS CUI [2]
C0153690
UMLS CUI [3]
C0153687
patient with a history of breast cancer
Beschrijving

History of Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0678222
other cancer currently in treatment (except carcinoma in situ).
Beschrijving

Therapeutic procedure Cancer Other | Exception Carcinoma in Situ

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007099
severe systemic disease potentially interfering with follow-up.
Beschrijving

Systemic disease Severe Interferes with Follow-up

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C3274571
contraindication to injected products: known allergy to bisphosphonates, zoledronic acid or excipients, severe renal failure (creatinine clearance < 30 ml/min with cockroft or mdrd method).
Beschrijving

Medical contraindication Injectables | Allergy to bisphosphonate | Allergy to zoledronic acid | Hypersensitivity Diphosphonates Excipient | Hypersensitivity Zoledronic acid Excipient | Kidney Failure Severe | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement MDRD

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0086466
UMLS CUI [2]
C0571738
UMLS CUI [3]
C4544924
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0012544
UMLS CUI [4,3]
C0015237
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0257685
UMLS CUI [5,3]
C0015237
UMLS CUI [6,1]
C0035078
UMLS CUI [6,2]
C0205082
UMLS CUI [7]
C2711451
UMLS CUI [8,1]
C0373595
UMLS CUI [8,2]
C3839656
women who are pregnant (positive pregnancy test) or breast-feeding, or absence of contraception in a woman who is able to become pregnant.
Beschrijving

Pregnancy | Pregnancy test positive | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0240802
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
patient with evolutionary dental problems, including dental infection or infection of the jaw,intrabuccal exposure of jawbone, and history or current diagnosis of osteonecrosis of the jaw,requiring a fast chirurgical care.
Beschrijving

Tooth problem | Tooth Infection | Infection jaw | Exposure Buccal Jaw | Osteonecrosis of Jaw Requirement Operative Surgical Procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0576962
UMLS CUI [2]
C0877046
UMLS CUI [3]
C1400570
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C0442010
UMLS CUI [4,3]
C0022359
UMLS CUI [5,1]
C2711248
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0543467
prior treatment with bisphosphonates (either iv or oral).
Beschrijving

Intravenous bisphosphonates | Diphosphonates Oral

Datatype

boolean

Alias
UMLS CUI [1]
C1955566
UMLS CUI [2,1]
C0012544
UMLS CUI [2,2]
C1527415
history of severe bone disease (severe osteoporosis with multiple skeletal-related events).
Beschrijving

Bone Disease Severe | Severe osteoporosis | Events Skeletal Multiple

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005940
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1859443
UMLS CUI [3,1]
C0441471
UMLS CUI [3,2]
C0521324
UMLS CUI [3,3]
C0439064
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Similar models

Eligibility Locally Advanced Breast Cancer NCT01367288

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women 18 years of age or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Medical contraindication Absent Zometa | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement MDRD
Item
absence of contraindication to treatment with zometa: creatinine clearance greater than 30 ml/min (with cockroft or mdrd method).
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0939788 (UMLS CUI [1,3])
C2711451 (UMLS CUI [2])
C0373595 (UMLS CUI [3,1])
C3839656 (UMLS CUI [3,2])
Breast Carcinoma TNM Breast tumor staging | Diameter Maximal | Benefit Due to Neoadjuvant Chemotherapy
Item
breast cancer (tnm iia, iib, iiia) larger than 2cm in maximal diameter able to benefit from neoadjuvant chemotherapy
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2,1])
C0205289 (UMLS CUI [2,2])
C0814225 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0600558 (UMLS CUI [3,3])
C3665472 (UMLS CUI [3,4])
Ductal Breast Carcinoma | Breast cancer, lobular
Item
ductal or lobular histological type of the breast tumor
boolean
C1527349 (UMLS CUI [1])
C3549742 (UMLS CUI [2])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
Comprehension French language
Item
patient who understands the french language
boolean
C0233733 (UMLS CUI [1,1])
C0376246 (UMLS CUI [1,2])
Social Security coverage
Item
covered by, or having the right to social security
boolean
C0037435 (UMLS CUI [1,1])
C1551362 (UMLS CUI [1,2])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Breast Carcinoma Histologic type Rare | Exception Ductal Breast Carcinoma | Exception Lobular breast cancer
Item
breast cancers of rare histological type (other than ductal and lobular)
boolean
C0678222 (UMLS CUI [1,1])
C0449574 (UMLS CUI [1,2])
C0522498 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1527349 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C3549742 (UMLS CUI [3,2])
Malignant Neoplasm Noninvasive
Item
noninvasive cancer
boolean
C0006826 (UMLS CUI [1,1])
C2986496 (UMLS CUI [1,2])
Multifocal tumor
Item
multifocal tumor (more than 2 tumoral lesions or 2 tumoral lesions distant more than 2cm each other)
boolean
C1302461 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging
Item
t4 breast tumor
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Organ Neoplasm Metastasis | Secondary malignant neoplasm of bone | Secondary malignant neoplasm of skin
Item
presence of organ, bone, or skin metastases (in the initial staging workup)
boolean
C0178784 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2])
C0153687 (UMLS CUI [3])
History of Breast Carcinoma
Item
patient with a history of breast cancer
boolean
C0262926 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Therapeutic procedure Cancer Other | Exception Carcinoma in Situ
Item
other cancer currently in treatment (except carcinoma in situ).
boolean
C0087111 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007099 (UMLS CUI [2,2])
Systemic disease Severe Interferes with Follow-up
Item
severe systemic disease potentially interfering with follow-up.
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C3274571 (UMLS CUI [1,4])
Medical contraindication Injectables | Allergy to bisphosphonate | Allergy to zoledronic acid | Hypersensitivity Diphosphonates Excipient | Hypersensitivity Zoledronic acid Excipient | Kidney Failure Severe | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement MDRD
Item
contraindication to injected products: known allergy to bisphosphonates, zoledronic acid or excipients, severe renal failure (creatinine clearance < 30 ml/min with cockroft or mdrd method).
boolean
C1301624 (UMLS CUI [1,1])
C0086466 (UMLS CUI [1,2])
C0571738 (UMLS CUI [2])
C4544924 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0012544 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0257685 (UMLS CUI [5,2])
C0015237 (UMLS CUI [5,3])
C0035078 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C2711451 (UMLS CUI [7])
C0373595 (UMLS CUI [8,1])
C3839656 (UMLS CUI [8,2])
Pregnancy | Pregnancy test positive | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
women who are pregnant (positive pregnancy test) or breast-feeding, or absence of contraception in a woman who is able to become pregnant.
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Tooth problem | Tooth Infection | Infection jaw | Exposure Buccal Jaw | Osteonecrosis of Jaw Requirement Operative Surgical Procedure
Item
patient with evolutionary dental problems, including dental infection or infection of the jaw,intrabuccal exposure of jawbone, and history or current diagnosis of osteonecrosis of the jaw,requiring a fast chirurgical care.
boolean
C0576962 (UMLS CUI [1])
C0877046 (UMLS CUI [2])
C1400570 (UMLS CUI [3])
C0332157 (UMLS CUI [4,1])
C0442010 (UMLS CUI [4,2])
C0022359 (UMLS CUI [4,3])
C2711248 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0543467 (UMLS CUI [5,3])
Intravenous bisphosphonates | Diphosphonates Oral
Item
prior treatment with bisphosphonates (either iv or oral).
boolean
C1955566 (UMLS CUI [1])
C0012544 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
Bone Disease Severe | Severe osteoporosis | Events Skeletal Multiple
Item
history of severe bone disease (severe osteoporosis with multiple skeletal-related events).
boolean
C0005940 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1859443 (UMLS CUI [2])
C0441471 (UMLS CUI [3,1])
C0521324 (UMLS CUI [3,2])
C0439064 (UMLS CUI [3,3])
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