ID

26907

Description

Study of Tumor and Blood Samples From Postmenopausal Women With Primary Breast Cancer Enrolled on Clinical Trial CAN-NCIC-MA27; ODM derived from: https://clinicaltrials.gov/show/NCT00968214

Link

https://clinicaltrials.gov/show/NCT00968214

Keywords

Versions (1)
  1. 10/28/17 10/28/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 28, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00968214

English

Eligibility Breast Cancer NCT00968214

1 forms  
Criteria
Description

Criteria

histologically or cytologically confirmed invasive breast cancer
Description

Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0853879
complete resection of primary tumor
Description

Complete excision Primary tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C0015250
UMLS CUI [1,2]
C0677930
stage i-iii (t1-3, n0-3, m0) disease
Description

Disease TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
enrolled in clinical trial can-ncic-ma27.
Description

Study Subject Participation Status | Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
no locally recurrent or metastatic breast cancer
Description

Exclusion Criteria | Breast cancer recurrent Local | Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0278493
UMLS CUI [2,2]
C0205276
UMLS CUI [3]
C0346993
hormone receptor status:
Description

Hormone Receptor Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
estrogen receptor- or progesterone receptor-positive disease
Description

Disease Estrogen receptor positive | Disease Progesterone receptor positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0279754
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0279759
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
postmenopausal status, defined as one of the following:
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
at least 60 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
age 45-59 years with spontaneous cessation of menses for > 12 months prior to chemotherapy or study randomization
Description

Age | Amenorrhea Spontaneous Duration | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0205359
UMLS CUI [2,3]
C0449238
UMLS CUI [3]
C0392920
age 45-59 years with cessation of menses for < 12 months or secondary to hysterectomy and a follicle-stimulating hormone (fsh) level in the postmenopausal range (or > 34.4 iu/l)
Description

Age | Amenorrhea Duration | Amenorrhea Secondary to Hysterectomy | FSH measurement Postmenopausal state | FSH measurement

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0002453
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C0020699
UMLS CUI [4,1]
C0202022
UMLS CUI [4,2]
C0232970
UMLS CUI [5]
C0202022
age 45-59 years on hormone replacement therapy (hrt) and discontinued hrt at diagnosis of breast cancer and fsh level in the postmenopausal range (or > 34.4 iu/l)
Description

Age | Hormone replacement therapy | Breast Carcinoma Diagnosis | Hormone replacement therapy Discontinued | FSH measurement Postmenopausal state | FSH measurement

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0282402
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C1704338
UMLS CUI [4,1]
C0282402
UMLS CUI [4,2]
C1444662
UMLS CUI [5,1]
C0202022
UMLS CUI [5,2]
C0232970
UMLS CUI [6]
C0202022
bilateral oophorectomy
Description

Bilateral oophorectomy

Data type

boolean

Alias
UMLS CUI [1]
C0278321
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

ID.16

Data type

boolean

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Similar models

Eligibility Breast Cancer NCT00968214

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Invasive carcinoma of breast
Item
histologically or cytologically confirmed invasive breast cancer
boolean
C0853879 (UMLS CUI [1])
Complete excision Primary tumor
Item
complete resection of primary tumor
boolean
C0015250 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
Disease TNM Breast tumor staging
Item
stage i-iii (t1-3, n0-3, m0) disease
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Study Subject Participation Status | Clinical Trial Specified
Item
enrolled in clinical trial can-ncic-ma27.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Exclusion Criteria | Breast cancer recurrent Local | Secondary malignant neoplasm of female breast
Item
no locally recurrent or metastatic breast cancer
boolean
C0680251 (UMLS CUI [1])
C0278493 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C0346993 (UMLS CUI [3])
Hormone Receptor Status
Item
hormone receptor status:
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Disease Estrogen receptor positive | Disease Progesterone receptor positive
Item
estrogen receptor- or progesterone receptor-positive disease
boolean
C0012634 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal status, defined as one of the following:
boolean
C0232970 (UMLS CUI [1])
Age
Item
at least 60 years old
boolean
C0001779 (UMLS CUI [1])
Age | Amenorrhea Spontaneous Duration | Chemotherapy
Item
age 45-59 years with spontaneous cessation of menses for > 12 months prior to chemotherapy or study randomization
boolean
C0001779 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0205359 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3])
Age | Amenorrhea Duration | Amenorrhea Secondary to Hysterectomy | FSH measurement Postmenopausal state | FSH measurement
Item
age 45-59 years with cessation of menses for < 12 months or secondary to hysterectomy and a follicle-stimulating hormone (fsh) level in the postmenopausal range (or > 34.4 iu/l)
boolean
C0001779 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0002453 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0020699 (UMLS CUI [3,3])
C0202022 (UMLS CUI [4,1])
C0232970 (UMLS CUI [4,2])
C0202022 (UMLS CUI [5])
Age | Hormone replacement therapy | Breast Carcinoma Diagnosis | Hormone replacement therapy Discontinued | FSH measurement Postmenopausal state | FSH measurement
Item
age 45-59 years on hormone replacement therapy (hrt) and discontinued hrt at diagnosis of breast cancer and fsh level in the postmenopausal range (or > 34.4 iu/l)
boolean
C0001779 (UMLS CUI [1])
C0282402 (UMLS CUI [2])
C0678222 (UMLS CUI [3,1])
C1704338 (UMLS CUI [3,2])
C0282402 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C0202022 (UMLS CUI [5,1])
C0232970 (UMLS CUI [5,2])
C0202022 (UMLS CUI [6])
Bilateral oophorectomy
Item
bilateral oophorectomy
boolean
C0278321 (UMLS CUI [1])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.16
Item
see disease characteristics
boolean
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