ID

26855

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00913016

Nyckelord

Versioner (1)
  1. 2017-10-26 2017-10-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 oktober 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00913016

Engelsk

Eligibility Breast Cancer NCT00913016

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

Operative Surgical Procedures Breast Carcinoma | Postmenopausal state | Age

Datatyp

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
Beskrivning

Serum follicle stimulating hormone measurement

Datatyp

boolean

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

Amenorrhea Duration

Datatyp

boolean

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

Ovariectomy

Datatyp

boolean

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

Estrogen receptor positive | Progesterone receptor positive

Datatyp

boolean

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

WHO performance status scale | ECOG performance status

Datatyp

boolean

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

Hematologic function | Renal function | Liver function

Datatyp

boolean

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

Neoplasm Metastasis Absent

Datatyp

boolean

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

Exclusion Criteria

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

Hormone Receptor Negative

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Hormone Therapy

Datatyp

boolean

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

Aromatase Inhibitors | Chemotherapy

Datatyp

boolean

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

Communicable Disease Uncontrolled | Heart Disease Control Unsuccessful

Datatyp

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
Beskrivning

Illness Serious | Malignant Neoplasms

Datatyp

boolean

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

Bone Mineral Density T score

Datatyp

boolean

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

Diphosphonates

Datatyp

boolean

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

Postmenopausal state | Chemotherapy

Datatyp

boolean

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

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Breast Cancer NCT00913016

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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