ID

19666

Beschreibung

A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS); ODM derived from: https://clinicaltrials.gov/show/NCT00183963

Link

https://clinicaltrials.gov/show/NCT00183963

Stichworte

Versionen (1)
  1. 20.01.17 20.01.17 -
Hochgeladen am

20. Januar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Carcinoma NCT00183963

Englisch

Eligibility Breast Carcinoma NCT00183963

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal women with newly diagnosed dcis. women will be considered to be in menopause if they fall into one of the following groups:
Beschreibung

Gender Postmenopausal state | Noninfiltrating Intraductal Carcinoma | Menopause criteria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0232970
UMLS CUI [2]
C0007124
UMLS CUI [3,1]
C0025320
UMLS CUI [3,2]
C0243161
age > 60
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
age > 45 with amenorrhea > 1 year with intact uterus
Beschreibung

Age | Amenorrhea disease length | Uterus Intact

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0872146
UMLS CUI [3,1]
C0042149
UMLS CUI [3,2]
C0205266
status post bilateral oophorectomies
Beschreibung

Bilateral oophorectomy Status post

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0278321
UMLS CUI [1,2]
C0231290
fsh/estradiol levels in postmenopausal range for the institution
Beschreibung

Follicle stimulating hormone measurement Range Postmenopausal | Estradiol measurement Range Postmenopausal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0202022
UMLS CUI [1,2]
C1514721
UMLS CUI [1,3]
C0232970
UMLS CUI [2,1]
C0337434
UMLS CUI [2,2]
C1514721
UMLS CUI [2,3]
C0232970
dcis must have been diagnosed with a minimally invasive biopsy technique, such as a vacuum-assisted large core tool (mammotome) or an equivalent method.
Beschreibung

Noninfiltrating Intraductal Carcinoma Method of biopsy Minimally invasive | Vacuum-Assisted Biopsy | Mammotome

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007124
UMLS CUI [1,2]
C0449327
UMLS CUI [1,3]
C2711297
UMLS CUI [2]
C1710607
UMLS CUI [3]
C3273259
there must be available tissue from the diagnostic biopsy to perform molecular markers.
Beschreibung

Biopsy Tissue specimen Available | Biological Markers performance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1292533
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C0005516
UMLS CUI [2,2]
C1882330
baseline mammogram within 8 weeks of study entry.
Beschreibung

Mammography

Datentyp

boolean

Alias
UMLS CUI [1]
C0024671
serum creatinine less than or equal to 2.0 mg/dl.
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
total bilirubin less than or equal to 2.0 upper limit of normal (uln), transaminases (sgot and/or sgpt) and alkaline phosphatase may be up to 2.5 x institutional upper limit of normal (uln), agc greater than or equal to 1500, platelets greater than or equal to 100,000, hemoglobin greater than or equal to 8.0 g/dl
Beschreibung

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
UMLS CUI [5]
C0948762
UMLS CUI [6]
C0032181
UMLS CUI [7]
C0518015
peripheral neuropathy grade 0-1.
Beschreibung

Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
no prior therapy for dcis.
Beschreibung

Therapeutic procedure Noninfiltrating Intraductal Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0007124
swog performance status of less than or equal to 1
Beschreibung

performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1518965
all patients must provide informed written consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior hormonal therapy (antiestrogens, estrogen, serm's, progestins, or aromatase inhibitors) within 6 months of study entry.
Beschreibung

Hormone Therapy | Estrogen Antagonists | Estrogens | Selective Estrogen Receptor Modulators | Progestins | Aromatase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0014930
UMLS CUI [3]
C0014939
UMLS CUI [4]
C0732611
UMLS CUI [5]
C0033306
UMLS CUI [6]
C0593802
underlying medical, psychiatric or social conditions that would preclude patient from receiving treatment.
Beschreibung

Medical condition Excludes Therapeutic procedure | Mental condition Excludes Therapeutic procedure | Social Condition Excludes Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C0037403
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0087111
history of dvt or pulmonary embolism
Beschreibung

Deep Vein Thrombosis | Pulmonary Embolism

Datentyp

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2]
C0034065
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Ähnliche Modelle

Eligibility Breast Carcinoma NCT00183963

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender Postmenopausal state | Noninfiltrating Intraductal Carcinoma | Menopause criteria
Item
postmenopausal women with newly diagnosed dcis. women will be considered to be in menopause if they fall into one of the following groups:
boolean
C0079399 (UMLS CUI [1,1])
C0232970 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2])
C0025320 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
Age
Item
age > 60
boolean
C0001779 (UMLS CUI [1])
Age | Amenorrhea disease length | Uterus Intact
Item
age > 45 with amenorrhea > 1 year with intact uterus
boolean
C0001779 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0042149 (UMLS CUI [3,1])
C0205266 (UMLS CUI [3,2])
Bilateral oophorectomy Status post
Item
status post bilateral oophorectomies
boolean
C0278321 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
Follicle stimulating hormone measurement Range Postmenopausal | Estradiol measurement Range Postmenopausal
Item
fsh/estradiol levels in postmenopausal range for the institution
boolean
C0202022 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
C0232970 (UMLS CUI [1,3])
C0337434 (UMLS CUI [2,1])
C1514721 (UMLS CUI [2,2])
C0232970 (UMLS CUI [2,3])
Noninfiltrating Intraductal Carcinoma Method of biopsy Minimally invasive | Vacuum-Assisted Biopsy | Mammotome
Item
dcis must have been diagnosed with a minimally invasive biopsy technique, such as a vacuum-assisted large core tool (mammotome) or an equivalent method.
boolean
C0007124 (UMLS CUI [1,1])
C0449327 (UMLS CUI [1,2])
C2711297 (UMLS CUI [1,3])
C1710607 (UMLS CUI [2])
C3273259 (UMLS CUI [3])
Biopsy Tissue specimen Available | Biological Markers performance
Item
there must be available tissue from the diagnostic biopsy to perform molecular markers.
boolean
C0005558 (UMLS CUI [1,1])
C1292533 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0005516 (UMLS CUI [2,1])
C1882330 (UMLS CUI [2,2])
Mammography
Item
baseline mammogram within 8 weeks of study entry.
boolean
C0024671 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine less than or equal to 2.0 mg/dl.
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
total bilirubin less than or equal to 2.0 upper limit of normal (uln), transaminases (sgot and/or sgpt) and alkaline phosphatase may be up to 2.5 x institutional upper limit of normal (uln), agc greater than or equal to 1500, platelets greater than or equal to 100,000, hemoglobin greater than or equal to 8.0 g/dl
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0948762 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0518015 (UMLS CUI [7])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy grade 0-1.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Therapeutic procedure Noninfiltrating Intraductal Carcinoma
Item
no prior therapy for dcis.
boolean
C0087111 (UMLS CUI [1,1])
C0007124 (UMLS CUI [1,2])
performance status
Item
swog performance status of less than or equal to 1
boolean
C1518965 (UMLS CUI [1])
Informed Consent
Item
all patients must provide informed written consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy | Estrogen Antagonists | Estrogens | Selective Estrogen Receptor Modulators | Progestins | Aromatase Inhibitors
Item
prior hormonal therapy (antiestrogens, estrogen, serm's, progestins, or aromatase inhibitors) within 6 months of study entry.
boolean
C0279025 (UMLS CUI [1])
C0014930 (UMLS CUI [2])
C0014939 (UMLS CUI [3])
C0732611 (UMLS CUI [4])
C0033306 (UMLS CUI [5])
C0593802 (UMLS CUI [6])
Medical condition Excludes Therapeutic procedure | Mental condition Excludes Therapeutic procedure | Social Condition Excludes Therapeutic procedure
Item
underlying medical, psychiatric or social conditions that would preclude patient from receiving treatment.
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0037403 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
Deep Vein Thrombosis | Pulmonary Embolism
Item
history of dvt or pulmonary embolism
boolean
C0149871 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
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