ID

26855

Descrição

Assessment of Quality of Life, Bone Density and Safety in Postmenopausal Breast Cancer Patients With Letrozole Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00913016

Link

https://clinicaltrials.gov/show/NCT00913016

Palavras-chave

Versões (1)
  1. 26/10/2017 26/10/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

26 de outubro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00913016

Inglês

Eligibility Breast Cancer NCT00913016

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients have undergone surgery of the breast cancer and proven histologically to be breast cancer with postmenopausal women older than 45 years. postmenopausal state was defined the following conditions, at least one of a, b, c.
Descrição

Operative Surgical Procedures Breast Carcinoma | Postmenopausal state | Age

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0001779
1. serum fsh ≥ 30 miu/ml
Descrição

Serum follicle stimulating hormone measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0455276
2. amenorrhea ≥ 1 year
Descrição

Amenorrhea Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0002453
UMLS CUI [1,2]
C0449238
3. oophorectomy
Descrição

Ovariectomy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029936
2. patients with estrogen receptor(+) and/or progesterone receptor(+)
Descrição

Estrogen receptor positive | Progesterone receptor positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0279759
3. who(ecog) performance status 0-2
Descrição

WHO performance status scale | ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2]
C1520224
4. adequate haematological function, renal function, hepatologic function.
Descrição

Hematologic function | Renal function | Liver function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
5. no evidence of metastasis.
Descrição

Neoplasm Metastasis Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient with hormone receptor negative.
Descrição

Hormone Receptor Negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1513916
2. patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell / squamous cell carcinoma of the skin.
Descrição

Malignant Neoplasms | Exception Breast Carcinoma | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0553723
UMLS CUI [5,3]
C1522326
3. other hormone therapy given within the previous 4 weeks.
Descrição

Hormone Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0279025
4. patients with other aromatase inhibitor and chemotherapy
Descrição

Aromatase Inhibitors | Chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0593802
UMLS CUI [2]
C0392920
5. uncontrolled infection, medically uncontrollable heart disease
Descrição

Communicable Disease Uncontrolled | Heart Disease Control Unsuccessful

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0243148
UMLS CUI [2,3]
C1272705
6. other serious medical illness or prior malignancies
Descrição

Illness Serious | Malignant Neoplasms

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0006826
7. patients with bmd t-score ≤-2.5
Descrição

Bone Mineral Density T score

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005938
UMLS CUI [1,2]
C3854607
8. patients who were treated with bisphosphonate
Descrição

Diphosphonates

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0012544
9. patients with postmenopausal state induced chemotherapy
Descrição

Postmenopausal state | Chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0392920
10. estimated life expectancy of <12 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Breast Cancer NCT00913016

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Operative Surgical Procedures Breast Carcinoma | Postmenopausal state | Age
Item
1. patients have undergone surgery of the breast cancer and proven histologically to be breast cancer with postmenopausal women older than 45 years. postmenopausal state was defined the following conditions, at least one of a, b, c.
boolean
C0543467 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Serum follicle stimulating hormone measurement
Item
1. serum fsh ≥ 30 miu/ml
boolean
C0455276 (UMLS CUI [1])
Amenorrhea Duration
Item
2. amenorrhea ≥ 1 year
boolean
C0002453 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Ovariectomy
Item
3. oophorectomy
boolean
C0029936 (UMLS CUI [1])
Estrogen receptor positive | Progesterone receptor positive
Item
2. patients with estrogen receptor(+) and/or progesterone receptor(+)
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
WHO performance status scale | ECOG performance status
Item
3. who(ecog) performance status 0-2
boolean
C1298650 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Hematologic function | Renal function | Liver function
Item
4. adequate haematological function, renal function, hepatologic function.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Neoplasm Metastasis Absent
Item
5. no evidence of metastasis.
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hormone Receptor Negative
Item
1. patient with hormone receptor negative.
boolean
C0019929 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Breast Carcinoma | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
2. patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell / squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
Hormone Therapy
Item
3. other hormone therapy given within the previous 4 weeks.
boolean
C0279025 (UMLS CUI [1])
Aromatase Inhibitors | Chemotherapy
Item
4. patients with other aromatase inhibitor and chemotherapy
boolean
C0593802 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Communicable Disease Uncontrolled | Heart Disease Control Unsuccessful
Item
5. uncontrolled infection, medically uncontrollable heart disease
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0243148 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
Illness Serious | Malignant Neoplasms
Item
6. other serious medical illness or prior malignancies
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
Bone Mineral Density T score
Item
7. patients with bmd t-score ≤-2.5
boolean
C0005938 (UMLS CUI [1,1])
C3854607 (UMLS CUI [1,2])
Diphosphonates
Item
8. patients who were treated with bisphosphonate
boolean
C0012544 (UMLS CUI [1])
Postmenopausal state | Chemotherapy
Item
9. patients with postmenopausal state induced chemotherapy
boolean
C0232970 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Life Expectancy
Item
10. estimated life expectancy of <12 months
boolean
C0023671 (UMLS CUI [1])
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