0 Evaluaciones

ID

14812

Descripción

Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Carboplatin in Triple Negative Breast Cancer (TNBC); ODM derived from: https://clinicaltrials.gov/show/NCT02341911

Link

https://clinicaltrials.gov/show/NCT02341911

Palabras clave

  1. 29/4/16 29/4/16 -
Subido en

29 de abril de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :


    Sin comentarios

    Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

    Eligibility Breast Cancer NCT02341911

    Eligibility Breast Cancer NCT02341911

    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. histological proven unresectable recurrent or advanced breast cancer, including de novo stage iv disease.
    Descripción

    Breast Carcinoma unresectable | Carcinoma breast stage IV de novo

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222
    UMLS CUI [1,2]
    C1519810
    UMLS CUI [2,1]
    C0278488
    UMLS CUI [2,2]
    C1515568
    2. triple-negative for estrogen receptor (er), progestogen receptor (pr), and human epithelial receptor-2 (her2) by immunohistochemistry (er <1%, pr <1% and her2 negative). a negative her2 gene amplification should be verified by fish test for those patients with her2 (2+). for those with her2 (1+), fish test might be considered by the investigator.
    Descripción

    Triple-Negative Breast Cancer Finding | Status of estrogen receptors of neoplasm | Status of progesterone receptors of neoplasm | erbB-2 Receptor | Immunohistochemistry | Human epidermal growth factor 2 negative carcinoma of breast | Human epidermal growth factor 2 gene amplification negative | Fluorescent in Situ Hybridization

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2348819
    UMLS CUI [2]
    C2919271
    UMLS CUI [3]
    C2919590
    UMLS CUI [4]
    C0069515
    UMLS CUI [5]
    C0021044
    UMLS CUI [6]
    C2316304
    UMLS CUI [7]
    C3874302
    UMLS CUI [8]
    C0162789
    3. no prior chemotherapy for metastatic breast cancer is permitted. prior administration of chemotherapy in the adjuvant/neoadjuvant setting is acceptable if completed 6 months before the enrollment.
    Descripción

    Prior Chemotherapy Carcinoma breast stage IV | Adjuvant therapy | Neoadjuvant Therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C0278488
    UMLS CUI [2]
    C0677850
    UMLS CUI [3]
    C0600558
    4. at least one measurable disease according to the response evaluation criteria in solid tumor (recist 1.1)
    Descripción

    Measurable Disease Response Evaluation Criteria in Solid Tumors

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1709926
    5. performance status no more than 1
    Descripción

    ECOG performance status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    6. all patients enrolled are required to have adequate hematologic, hepatic, and renal function
    Descripción

    Hematologic function | Liver function | Renal function

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0221130
    UMLS CUI [2]
    C0232741
    UMLS CUI [3]
    C0232804
    7. life expectancy longer than 12 weeks
    Descripción

    Life Expectancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    8. no serious medical history of heart, lung, liver and kidney
    Descripción

    Heart Diseases | Lung diseases | Liver diseases | Kidney Diseases

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0018799
    UMLS CUI [2]
    C0024115
    UMLS CUI [3]
    C0023895
    UMLS CUI [4]
    C0022658
    9. be able to understand the study procedures and sign informed consent.
    Descripción

    Comprehension Study Protocol Informed Consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0162340
    UMLS CUI [1,2]
    C2348563
    UMLS CUI [1,3]
    C0021430
    10. patients with good compliance
    Descripción

    Compliance behavior Good

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0205170
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound)
    Descripción

    Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative Ultrasonics (sound)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0430061
    UMLS CUI [3,3]
    C1456803
    2. women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
    Descripción

    Childbearing Potential | Unwilling Contraceptive methods

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3831118
    UMLS CUI [2,1]
    C0558080
    UMLS CUI [2,2]
    C0700589
    3. treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy
    Descripción

    Therapeutic radiology procedure Entire axial skeleton | Toxic effect Prior radiation therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C1321508
    UMLS CUI [2,1]
    C0600688
    UMLS CUI [2,2]
    C0279134
    4. treatment with an investigational product within 4 weeks before the first treatment
    Descripción

    Therapeutic procedure Investigational New Drugs

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0013230
    5. patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. radiotherapy should be completed within 4 weeks prior to the registration
    Descripción

    CNS metastases | Metastatic malignant neoplasm to brain | Cranial Irradiation | Measurable Disease | Therapeutic radiology procedure

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0686377
    UMLS CUI [2]
    C0220650
    UMLS CUI [3]
    C0079172
    UMLS CUI [4]
    C1513041
    UMLS CUI [5]
    C1522449
    6. other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
    Descripción

    Malignant Neoplasms | Hematologic Neoplasms | Skin carcinoma | Cervical Intraepithelial Neoplasia

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0376545
    UMLS CUI [3]
    C0699893
    UMLS CUI [4]
    C0206708
    7. patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
    Descripción

    Cardiovascular Diseases | Liver diseases | Respiration Disorders | Kidney Diseases | Abnormality of blood and blood-forming tissues | Abnormality of the endocrine system | nervous system disorder | Mental disorders

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0007222
    UMLS CUI [2]
    C0023895
    UMLS CUI [3]
    C0035204
    UMLS CUI [4]
    C0022658
    UMLS CUI [5]
    C0850715
    UMLS CUI [6]
    C4025823
    UMLS CUI [7]
    C0027765
    UMLS CUI [8]
    C0004936
    8. uncontrolled serious infection
    Descripción

    Communicable Diseases Uncontrolled

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205318

    Similar models

    Eligibility Breast Cancer NCT02341911

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Breast Carcinoma unresectable | Carcinoma breast stage IV de novo
    Item
    1. histological proven unresectable recurrent or advanced breast cancer, including de novo stage iv disease.
    boolean
    C0678222 (UMLS CUI [1,1])
    C1519810 (UMLS CUI [1,2])
    C0278488 (UMLS CUI [2,1])
    C1515568 (UMLS CUI [2,2])
    Triple-Negative Breast Cancer Finding | Status of estrogen receptors of neoplasm | Status of progesterone receptors of neoplasm | erbB-2 Receptor | Immunohistochemistry | Human epidermal growth factor 2 negative carcinoma of breast | Human epidermal growth factor 2 gene amplification negative | Fluorescent in Situ Hybridization
    Item
    2. triple-negative for estrogen receptor (er), progestogen receptor (pr), and human epithelial receptor-2 (her2) by immunohistochemistry (er <1%, pr <1% and her2 negative). a negative her2 gene amplification should be verified by fish test for those patients with her2 (2+). for those with her2 (1+), fish test might be considered by the investigator.
    boolean
    C2348819 (UMLS CUI [1])
    C2919271 (UMLS CUI [2])
    C2919590 (UMLS CUI [3])
    C0069515 (UMLS CUI [4])
    C0021044 (UMLS CUI [5])
    C2316304 (UMLS CUI [6])
    C3874302 (UMLS CUI [7])
    C0162789 (UMLS CUI [8])
    Prior Chemotherapy Carcinoma breast stage IV | Adjuvant therapy | Neoadjuvant Therapy
    Item
    3. no prior chemotherapy for metastatic breast cancer is permitted. prior administration of chemotherapy in the adjuvant/neoadjuvant setting is acceptable if completed 6 months before the enrollment.
    boolean
    C1514457 (UMLS CUI [1,1])
    C0278488 (UMLS CUI [1,2])
    C0677850 (UMLS CUI [2])
    C0600558 (UMLS CUI [3])
    Measurable Disease Response Evaluation Criteria in Solid Tumors
    Item
    4. at least one measurable disease according to the response evaluation criteria in solid tumor (recist 1.1)
    boolean
    C1513041 (UMLS CUI [1,1])
    C1709926 (UMLS CUI [1,2])
    ECOG performance status
    Item
    5. performance status no more than 1
    boolean
    C1520224 (UMLS CUI [1])
    Hematologic function | Liver function | Renal function
    Item
    6. all patients enrolled are required to have adequate hematologic, hepatic, and renal function
    boolean
    C0221130 (UMLS CUI [1])
    C0232741 (UMLS CUI [2])
    C0232804 (UMLS CUI [3])
    Life Expectancy
    Item
    7. life expectancy longer than 12 weeks
    boolean
    C0023671 (UMLS CUI [1])
    Heart Diseases | Lung diseases | Liver diseases | Kidney Diseases
    Item
    8. no serious medical history of heart, lung, liver and kidney
    boolean
    C0018799 (UMLS CUI [1])
    C0024115 (UMLS CUI [2])
    C0023895 (UMLS CUI [3])
    C0022658 (UMLS CUI [4])
    Comprehension Study Protocol Informed Consent
    Item
    9. be able to understand the study procedures and sign informed consent.
    boolean
    C0162340 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [1,3])
    Compliance behavior Good
    Item
    10. patients with good compliance
    boolean
    C1321605 (UMLS CUI [1,1])
    C0205170 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative Ultrasonics (sound)
    Item
    1. pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound)
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0430061 (UMLS CUI [3,2])
    C1456803 (UMLS CUI [3,3])
    Childbearing Potential | Unwilling Contraceptive methods
    Item
    2. women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
    boolean
    C3831118 (UMLS CUI [1])
    C0558080 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    Therapeutic radiology procedure Entire axial skeleton | Toxic effect Prior radiation therapy
    Item
    3. treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy
    boolean
    C1522449 (UMLS CUI [1,1])
    C1321508 (UMLS CUI [1,2])
    C0600688 (UMLS CUI [2,1])
    C0279134 (UMLS CUI [2,2])
    Therapeutic procedure Investigational New Drugs
    Item
    4. treatment with an investigational product within 4 weeks before the first treatment
    boolean
    C0087111 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    CNS metastases | Metastatic malignant neoplasm to brain | Cranial Irradiation | Measurable Disease | Therapeutic radiology procedure
    Item
    5. patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. radiotherapy should be completed within 4 weeks prior to the registration
    boolean
    C0686377 (UMLS CUI [1])
    C0220650 (UMLS CUI [2])
    C0079172 (UMLS CUI [3])
    C1513041 (UMLS CUI [4])
    C1522449 (UMLS CUI [5])
    Malignant Neoplasms | Hematologic Neoplasms | Skin carcinoma | Cervical Intraepithelial Neoplasia
    Item
    6. other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
    boolean
    C0006826 (UMLS CUI [1])
    C0376545 (UMLS CUI [2])
    C0699893 (UMLS CUI [3])
    C0206708 (UMLS CUI [4])
    Cardiovascular Diseases | Liver diseases | Respiration Disorders | Kidney Diseases | Abnormality of blood and blood-forming tissues | Abnormality of the endocrine system | nervous system disorder | Mental disorders
    Item
    7. patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
    boolean
    C0007222 (UMLS CUI [1])
    C0023895 (UMLS CUI [2])
    C0035204 (UMLS CUI [3])
    C0022658 (UMLS CUI [4])
    C0850715 (UMLS CUI [5])
    C4025823 (UMLS CUI [6])
    C0027765 (UMLS CUI [7])
    C0004936 (UMLS CUI [8])
    Communicable Diseases Uncontrolled
    Item
    8. uncontrolled serious infection
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial