ID

37835

Beskrivning

Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01112826

Länk

https://clinicaltrials.gov/show/NCT01112826

Nyckelord

Versioner (1)
  1. 2019-08-26 2019-08-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01112826

Engelsk

Eligibility Breast Cancer NCT01112826

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be >=18 years of age;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
the patients must be operable primary invasive breast cancer;
Beskrivning

Invasive carcinoma of breast Operable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205188
definitive loco-regional surgery must be completed;
Beskrivning

Operative Surgical Procedure Local-Regional Completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1947913
UMLS CUI [1,3]
C0205197
primary tumor centrally confirmed as triple negative;
Beskrivning

Triple Negative Breast Neoplasm

Datatyp

boolean

Alias
UMLS CUI [1]
C3539878
operable node-positive (or node-negative with tumor diameter ≥ 0.5cm);
Beskrivning

Node-positive breast cancer Operable | Node-negative breast cancer Diameter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3160887
UMLS CUI [1,2]
C0205188
UMLS CUI [2,1]
C3160889
UMLS CUI [2,2]
C1301886
chest, abdominal, bone imaging performed with 3 months prior to randomization must not reveal the presence of distant spread;
Beskrivning

Distant metastasis Absent Chest imaging | Distant metastasis Absent Abdominal imaging | Distant metastasis Absent Bone imaging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1531652
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C4481095
UMLS CUI [3,1]
C1269798
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0203668
there are normal organ function, including bone marrow function, renal function, liver function, and cardiac function;
Beskrivning

Organ function | Bone Marrow function | Renal function | Liver function | Cardiac function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0232741
UMLS CUI [5]
C0232164
all patients must have signed and dated an informed consent form.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with bilateral breast cancer, inflammatory carcinomas;
Beskrivning

Bilateral breast cancer | Inflammatory carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0281267
UMLS CUI [2]
C0334385
patients with positive supraclavicular or internal mammary lymph node;
Beskrivning

Supraclavicular lymph node Positive | Internal Mammary Lymph Node Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0229730
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0229755
UMLS CUI [2,2]
C1514241
previous breast cancer history;
Beskrivning

Medical History Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0678222
any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin;
Beskrivning

Malignant Neoplasms Previous | Exception Cervix carcinoma | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0302592
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
pregnant or breast-feeding women;
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women who are unwilling to agree to use an effective non-hormonal method of contraception during the treatment period of xeloda;
Beskrivning

Gender Contraceptive methods Unwilling | Exception Hormonal contraception | Time period Xeloda Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2985296
UMLS CUI [3,1]
C1948053
UMLS CUI [3,2]
C0724419
UMLS CUI [3,3]
C0087111
any sex hormonal therapy;
Beskrivning

Gonadal Steroid Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036884
UMLS CUI [1,2]
C0087111
malabsorption syndrome.
Beskrivning

Malabsorption Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0024523
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Similar models

Eligibility Breast Cancer NCT01112826

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients must be >=18 years of age;
boolean
C0001779 (UMLS CUI [1])
Invasive carcinoma of breast Operable
Item
the patients must be operable primary invasive breast cancer;
boolean
C0853879 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
Operative Surgical Procedure Local-Regional Completed
Item
definitive loco-regional surgery must be completed;
boolean
C0543467 (UMLS CUI [1,1])
C1947913 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Triple Negative Breast Neoplasm
Item
primary tumor centrally confirmed as triple negative;
boolean
C3539878 (UMLS CUI [1])
Node-positive breast cancer Operable | Node-negative breast cancer Diameter
Item
operable node-positive (or node-negative with tumor diameter ≥ 0.5cm);
boolean
C3160887 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
C3160889 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
Distant metastasis Absent Chest imaging | Distant metastasis Absent Abdominal imaging | Distant metastasis Absent Bone imaging
Item
chest, abdominal, bone imaging performed with 3 months prior to randomization must not reveal the presence of distant spread;
boolean
C1269798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1531652 (UMLS CUI [1,3])
C1269798 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C4481095 (UMLS CUI [2,3])
C1269798 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0203668 (UMLS CUI [3,3])
Organ function | Bone Marrow function | Renal function | Liver function | Cardiac function
Item
there are normal organ function, including bone marrow function, renal function, liver function, and cardiac function;
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C0232164 (UMLS CUI [5])
Informed Consent
Item
all patients must have signed and dated an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bilateral breast cancer | Inflammatory carcinoma
Item
patients with bilateral breast cancer, inflammatory carcinomas;
boolean
C0281267 (UMLS CUI [1])
C0334385 (UMLS CUI [2])
Supraclavicular lymph node Positive | Internal Mammary Lymph Node Positive
Item
patients with positive supraclavicular or internal mammary lymph node;
boolean
C0229730 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0229755 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Medical History Breast Carcinoma
Item
previous breast cancer history;
boolean
C0262926 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Malignant Neoplasms Previous | Exception Cervix carcinoma | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma
Item
any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin;
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0302592 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Contraceptive methods Unwilling | Exception Hormonal contraception | Time period Xeloda Therapy
Item
women who are unwilling to agree to use an effective non-hormonal method of contraception during the treatment period of xeloda;
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C2985296 (UMLS CUI [2,2])
C1948053 (UMLS CUI [3,1])
C0724419 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
Gonadal Steroid Hormone Therapy
Item
any sex hormonal therapy;
boolean
C0036884 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Malabsorption Syndrome
Item
malabsorption syndrome.
boolean
C0024523 (UMLS CUI [1])
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