ID

37777

Beschrijving

Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women; ODM derived from: https://clinicaltrials.gov/show/NCT01069211

Link

https://clinicaltrials.gov/show/NCT01069211

Trefwoorden

Versies (2)
  1. 23-08-19 23-08-19 -
  2. 27-09-21 27-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01069211

Engels

Eligibility Breast Cancer NCT01069211

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with estrogen receptor(+) and/or progesterone receptor(+)
Beschrijving

Estrogen receptor positive | Progesterone receptor positive

Datatype

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0279759
2. postmenopausal state was defined the following conditions, at least one of a, b
Beschrijving

Postmenopausal state

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
1. serum fsh ≥ 30 miu/ml and amenorrhea ≥ 1 year for below 55 years, over than 55 years
Beschrijving

Serum follicle stimulating hormone measurement | Amenorrhea Duration | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0455276
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3]
C0001779
2. bilateral oophorectomy
Beschrijving

Bilateral oophorectomy

Datatype

boolean

Alias
UMLS CUI [1]
C0278321
3. patients have undergone surgery of the breast cancer within 12 weeks and terminated chemotherapy after surgery within 4 weeks.
Beschrijving

Operative Surgical Procedure Breast Carcinoma | Chemotherapy Completed | Status post Operative Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0543467
4. who(ecog) performance status 0-2
Beschrijving

WHO performance status scale | ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2]
C1520224
5. adequate haematological function, renal function, hepatic function.
Beschrijving

Hematologic function | Renal function | Liver function

Datatype

boolean

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

Neoplasm Metastasis Absent

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. metachronous bilateral breast cancer.
Beschrijving

Bilateral breast cancer Metachronous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0281267
UMLS CUI [1,2]
C1334703
2. metastatic breast cancer (stage iv)
Beschrijving

Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1]
C0346993
3. other hormone therapy and hormonal replacement therapy given within the previous 4 weeks, except for estring, vagifem, estrogen cream.
Beschrijving

Hormone Therapy | Hormone replacement therapy | Exception Estring | Exception Vagifem | Exception Estrogen Cream

Datatype

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0282402
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0591465
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0592238
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0014939
UMLS CUI [5,3]
C1378128
4. patients with child-pugh grade c, serum creatinine>2xunl
Beschrijving

Child-Pugh Classification | Serum creatinine raised

Datatype

boolean

Alias
UMLS CUI [1]
C2347612
UMLS CUI [2]
C0700225
5. patients with gastrectomy, small bowel resection, malabsorption syndrome and dysphagia.
Beschrijving

Gastrectomy | Small intestine excision | Malabsorption Syndrome | Deglutition Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0017118
UMLS CUI [2]
C0192601
UMLS CUI [3]
C0024523
UMLS CUI [4]
C0011168
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Similar models

Eligibility Breast Cancer NCT01069211

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Estrogen receptor positive | Progesterone receptor positive
Item
1. patients with estrogen receptor(+) and/or progesterone receptor(+)
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
Postmenopausal state
Item
2. postmenopausal state was defined the following conditions, at least one of a, b
boolean
C0232970 (UMLS CUI [1])
Serum follicle stimulating hormone measurement | Amenorrhea Duration | Age
Item
1. serum fsh ≥ 30 miu/ml and amenorrhea ≥ 1 year for below 55 years, over than 55 years
boolean
C0455276 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
Bilateral oophorectomy
Item
2. bilateral oophorectomy
boolean
C0278321 (UMLS CUI [1])
Operative Surgical Procedure Breast Carcinoma | Chemotherapy Completed | Status post Operative Surgical Procedures
Item
3. patients have undergone surgery of the breast cancer within 12 weeks and terminated chemotherapy after surgery within 4 weeks.
boolean
C0543467 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
WHO performance status scale | ECOG performance status
Item
4. who(ecog) performance status 0-2
boolean
C1298650 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Hematologic function | Renal function | Liver function
Item
5. adequate haematological function, renal function, hepatic function.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Neoplasm Metastasis Absent
Item
6. no evidence of metastasis.
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Bilateral breast cancer Metachronous
Item
1. metachronous bilateral breast cancer.
boolean
C0281267 (UMLS CUI [1,1])
C1334703 (UMLS CUI [1,2])
Secondary malignant neoplasm of female breast
Item
2. metastatic breast cancer (stage iv)
boolean
C0346993 (UMLS CUI [1])
Hormone Therapy | Hormone replacement therapy | Exception Estring | Exception Vagifem | Exception Estrogen Cream
Item
3. other hormone therapy and hormonal replacement therapy given within the previous 4 weeks, except for estring, vagifem, estrogen cream.
boolean
C0279025 (UMLS CUI [1])
C0282402 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0591465 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0592238 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0014939 (UMLS CUI [5,2])
C1378128 (UMLS CUI [5,3])
Child-Pugh Classification | Serum creatinine raised
Item
4. patients with child-pugh grade c, serum creatinine>2xunl
boolean
C2347612 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Gastrectomy | Small intestine excision | Malabsorption Syndrome | Deglutition Disorders
Item
5. patients with gastrectomy, small bowel resection, malabsorption syndrome and dysphagia.
boolean
C0017118 (UMLS CUI [1])
C0192601 (UMLS CUI [2])
C0024523 (UMLS CUI [3])
C0011168 (UMLS CUI [4])
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