ID

35073

Beschrijving

Evaluation of the Relationship of TOP2α Expression and Effect of Non Dose-dense Chemotherapy for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02506361

Link

https://clinicaltrials.gov/show/NCT02506361

Trefwoorden

Versies (1)
  1. 13-02-19 13-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

13 februari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02506361

Engels

Eligibility Breast Cancer NCT02506361

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
for inclusion in the study, subjects must fulfil all of the following criteria:
Beschrijving

Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. . signed and dated informed consent indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
Beschrijving

Informed Consent | Informed Consent Patient Representative

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
2. . invasive breast cancer confirmed by histology or cytology with the tumor complete resection.
Beschrijving

Invasive carcinoma of breast | Complete excision Tumor

Datatype

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C0015250
UMLS CUI [2,2]
C0027651
3. . patients without remote organs metastasis.
Beschrijving

Absence Neoplasm Metastasis Organ Remote

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0178784
UMLS CUI [1,4]
C0205157
4. . the ages of patients ≥ 18 years and ≤70 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
5. . patients with positive axillary lymph nodes, or negative axillary lymph nodes plus one of these conditions: triple-negative breast cancer, her- 2(+),ki-67≥15%.
Beschrijving

Positive Axillary Lymph Node | Negative Axillary Lymph Node plus Triple Negative Breast Neoplasm | Negative Axillary Lymph Node plus HER2 Positive | Negative Axillary Lymph Node plus Ki67 Measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0677929
UMLS CUI [2,1]
C0279781
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C3539878
UMLS CUI [3,1]
C0279781
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C2348909
UMLS CUI [4,1]
C0279781
UMLS CUI [4,2]
C0332287
UMLS CUI [4,3]
C4049944
6. . the values of aspartate aminotransferase(ast),alanine aminotransferase(alt), alkaline phosphatase(alp), total bilirubin(tbil), urea, crea were less than 2 times of upper limits of normal at the beginning of aromatase inhibitors（ais） therapy.
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement | Urea measurement | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201850
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0523961
UMLS CUI [6]
C0201976
7. . top2α is available to be detected in the primary tumour tissue.
Beschrijving

TOP2 Detectable Primary tumor tissue

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012863
UMLS CUI [1,2]
C3830527
UMLS CUI [1,3]
C0677930
UMLS CUI [1,4]
C0040300
8. . patients received the regimens of anthracyclines followed taxanes or containing no taxanes non-dose dense chemotherapy suggested by the guidelines of national comprehensive cancer network （nccn) 2014.
Beschrijving

Anthracyclines | Taxanes

Datatype

boolean

Alias
UMLS CUI [1]
C0003234
UMLS CUI [2]
C0796419
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any of the following is regarded as a criterion for exclusion from the study:
Beschrijving

Exclusion Criteria Any

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1552551
1. . patients is in the period of pregnancy or lactation.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. . bilateral breast cancer, inflammatory breast cancer or carcinoma in situ.
Beschrijving

Bilateral breast cancer | Inflammatory Breast Carcinoma | Carcinoma in Situ

Datatype

boolean

Alias
UMLS CUI [1]
C0281267
UMLS CUI [2]
C0278601
UMLS CUI [3]
C0007099
3. . previous received neo-adjuvant therapy, including chemotherapy, radiotherapy or endocrinotherapy.
Beschrijving

Neoadjuvant Therapy | Chemotherapy | Therapeutic radiology procedure | Hormone Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0600558
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0279025
4. . presence of other life-threatening cancers.
Beschrijving

Cancer Other Life Threatening

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C2826244
5. . any severe concomitant condition: uncontrolled cardiac disease or uncontrolled diabetes mellitus. et al.
Beschrijving

Comorbidity Severe | Heart Disease Uncontrolled | Diabetic - poor control

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0421258
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Similar models

Eligibility Breast Cancer NCT02506361

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
for inclusion in the study, subjects must fulfil all of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Informed Consent | Informed Consent Patient Representative
Item
1. . signed and dated informed consent indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Invasive carcinoma of breast | Complete excision Tumor
Item
2. . invasive breast cancer confirmed by histology or cytology with the tumor complete resection.
boolean
C0853879 (UMLS CUI [1])
C0015250 (UMLS CUI [2,1])
C0027651 (UMLS CUI [2,2])
Absence Neoplasm Metastasis Organ Remote
Item
3. . patients without remote organs metastasis.
boolean
C0332197 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0178784 (UMLS CUI [1,3])
C0205157 (UMLS CUI [1,4])
Age
Item
4. . the ages of patients ≥ 18 years and ≤70 years.
boolean
C0001779 (UMLS CUI [1])
Positive Axillary Lymph Node | Negative Axillary Lymph Node plus Triple Negative Breast Neoplasm | Negative Axillary Lymph Node plus HER2 Positive | Negative Axillary Lymph Node plus Ki67 Measurement
Item
5. . patients with positive axillary lymph nodes, or negative axillary lymph nodes plus one of these conditions: triple-negative breast cancer, her- 2(+),ki-67≥15%.
boolean
C0677929 (UMLS CUI [1])
C0279781 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C3539878 (UMLS CUI [2,3])
C0279781 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C2348909 (UMLS CUI [3,3])
C0279781 (UMLS CUI [4,1])
C0332287 (UMLS CUI [4,2])
C4049944 (UMLS CUI [4,3])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement | Urea measurement | Creatinine measurement, serum
Item
6. . the values of aspartate aminotransferase(ast),alanine aminotransferase(alt), alkaline phosphatase(alp), total bilirubin(tbil), urea, crea were less than 2 times of upper limits of normal at the beginning of aromatase inhibitors（ais） therapy.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0523961 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
TOP2 Detectable Primary tumor tissue
Item
7. . top2α is available to be detected in the primary tumour tissue.
boolean
C0012863 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
C0040300 (UMLS CUI [1,4])
Anthracyclines | Taxanes
Item
8. . patients received the regimens of anthracyclines followed taxanes or containing no taxanes non-dose dense chemotherapy suggested by the guidelines of national comprehensive cancer network （nccn) 2014.
boolean
C0003234 (UMLS CUI [1])
C0796419 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Any
Item
any of the following is regarded as a criterion for exclusion from the study:
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
1. . patients is in the period of pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Bilateral breast cancer | Inflammatory Breast Carcinoma | Carcinoma in Situ
Item
2. . bilateral breast cancer, inflammatory breast cancer or carcinoma in situ.
boolean
C0281267 (UMLS CUI [1])
C0278601 (UMLS CUI [2])
C0007099 (UMLS CUI [3])
Neoadjuvant Therapy | Chemotherapy | Therapeutic radiology procedure | Hormone Therapy
Item
3. . previous received neo-adjuvant therapy, including chemotherapy, radiotherapy or endocrinotherapy.
boolean
C0600558 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
Cancer Other Life Threatening
Item
4. . presence of other life-threatening cancers.
boolean
C1707251 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Comorbidity Severe | Heart Disease Uncontrolled | Diabetic - poor control
Item
5. . any severe concomitant condition: uncontrolled cardiac disease or uncontrolled diabetes mellitus. et al.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0421258 (UMLS CUI [3])
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