ID

19646

Description

S8814A Biomarkers in Predicting Outcome in Postmenopausal Women With Hormone Receptor-Positive, Node-Positive Breast Cancer Treated With Tamoxifen With or Without Cyclophosphamide, Doxorubicin, and Fluorouracil; ODM derived from: https://clinicaltrials.gov/show/NCT00897091

Link

https://clinicaltrials.gov/show/NCT00897091

Keywords

Versions (1)
  1. 1/18/17 1/18/17 -
Uploaded on

January 18, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00897091

English

Eligibility Breast Cancer NCT00897091

1 forms  
Criteria
Description

Criteria

histologically confirmed breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
node-positive disease (pt1-3a, pn1-2 [clinical n0-1], m0)
Description

Disease lymph node positive TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0746319
UMLS CUI [1,3]
C3258246
previously enrolled in swog-8814, a treatment clinical trial, and in swog-9445, a companion tissue banking study
Description

Study Subject Participation Status | Therapeutic procedure Clinical Trial | Tissue Banking Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0008976
UMLS CUI [3,1]
C0087095
UMLS CUI [3,2]
C0008976
tumor block or unstained sections available from initial diagnosis in the swog archive
Description

Tumor Paraffin Block at initial diagnosis Available | Unstained Specimen at initial diagnosis Available

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1519524
UMLS CUI [1,3]
C4071762
UMLS CUI [1,4]
C0470187
UMLS CUI [2,1]
C1883469
UMLS CUI [2,2]
C4071762
UMLS CUI [2,3]
C0470187
sufficient tumor in block or unstained sections
Description

Tumor Sufficient Paraffin Block | Tumor Sufficient Unstained Specimen

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0205410
UMLS CUI [1,3]
C1519524
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C0205410
UMLS CUI [2,3]
C1883469
patients for whom only unstained slides are available must have acceptable reverse-transcriptase-polymerase chain reaction (rt-pcr) profiles
Description

Unstained Specimen Alone Available | Reverse Transcriptase Polymerase Chain Reaction Profile Acceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C1883469
UMLS CUI [1,2]
C0205171
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C0599161
UMLS CUI [2,2]
C1979963
UMLS CUI [2,3]
C1879533
sufficient rna (≥ 300 ng) for rt-pcr analysis with the oncotype dx 21 gene assay
Description

RNA Sufficient Reverse Transcriptase Polymerase Chain Reaction Analysis | Oncotype DX Breast Cancer Assay

Data type

boolean

Alias
UMLS CUI [1,1]
C0035668
UMLS CUI [1,2]
C0205410
UMLS CUI [1,3]
C0599161
UMLS CUI [1,4]
C0002778
UMLS CUI [2]
C1709318
average normalized cycle threshold for the 5 reference genes ≤ 35
Description

Cycle Threshold Average Normalized | Genes Quantity Reference

Data type

boolean

Alias
UMLS CUI [1,1]
C1511572
UMLS CUI [1,2]
C0449864
UMLS CUI [1,3]
C1510992
UMLS CUI [1,4]
C1882115
UMLS CUI [2,1]
C0017337
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1706462
follow-up data from the swog-8814 clinical trial obtained from the patient
Description

Clinical Study Follow-up Data

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1511726
hormone receptor status:
Description

Hormone Receptor Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
estrogen and/or progesterone receptor positive tumor
Description

Estrogen receptor positive tumor | Progesterone receptor positive tumor

Data type

boolean

Alias
UMLS CUI [1]
C1562312
UMLS CUI [2]
C1562928
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
postmenopausal
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

disease characteristic

Data type

boolean

Alias
UMLS CUI [1]
C0599878
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Similar models

Eligibility Breast Cancer NCT00897091

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breast Carcinoma
Item
histologically confirmed breast cancer
boolean
C0678222 (UMLS CUI [1])
Disease lymph node positive TNM clinical staging
Item
node-positive disease (pt1-3a, pn1-2 [clinical n0-1], m0)
boolean
C0012634 (UMLS CUI [1,1])
C0746319 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Study Subject Participation Status | Therapeutic procedure Clinical Trial | Tissue Banking Clinical Trial
Item
previously enrolled in swog-8814, a treatment clinical trial, and in swog-9445, a companion tissue banking study
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0087095 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
Tumor Paraffin Block at initial diagnosis Available | Unstained Specimen at initial diagnosis Available
Item
tumor block or unstained sections available from initial diagnosis in the swog archive
boolean
C0475358 (UMLS CUI [1,1])
C1519524 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,4])
C1883469 (UMLS CUI [2,1])
C4071762 (UMLS CUI [2,2])
C0470187 (UMLS CUI [2,3])
Tumor Sufficient Paraffin Block | Tumor Sufficient Unstained Specimen
Item
sufficient tumor in block or unstained sections
boolean
C0475358 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C1519524 (UMLS CUI [1,3])
C0475358 (UMLS CUI [2,1])
C0205410 (UMLS CUI [2,2])
C1883469 (UMLS CUI [2,3])
Unstained Specimen Alone Available | Reverse Transcriptase Polymerase Chain Reaction Profile Acceptable
Item
patients for whom only unstained slides are available must have acceptable reverse-transcriptase-polymerase chain reaction (rt-pcr) profiles
boolean
C1883469 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0599161 (UMLS CUI [2,1])
C1979963 (UMLS CUI [2,2])
C1879533 (UMLS CUI [2,3])
RNA Sufficient Reverse Transcriptase Polymerase Chain Reaction Analysis | Oncotype DX Breast Cancer Assay
Item
sufficient rna (≥ 300 ng) for rt-pcr analysis with the oncotype dx 21 gene assay
boolean
C0035668 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0599161 (UMLS CUI [1,3])
C0002778 (UMLS CUI [1,4])
C1709318 (UMLS CUI [2])
Cycle Threshold Average Normalized | Genes Quantity Reference
Item
average normalized cycle threshold for the 5 reference genes ≤ 35
boolean
C1511572 (UMLS CUI [1,1])
C0449864 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C1882115 (UMLS CUI [1,4])
C0017337 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1706462 (UMLS CUI [2,3])
Clinical Study Follow-up Data
Item
follow-up data from the swog-8814 clinical trial obtained from the patient
boolean
C3274571 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
Hormone Receptor Status
Item
hormone receptor status:
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Estrogen receptor positive tumor | Progesterone receptor positive tumor
Item
estrogen and/or progesterone receptor positive tumor
boolean
C1562312 (UMLS CUI [1])
C1562928 (UMLS CUI [2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal
boolean
C0232970 (UMLS CUI [1])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
disease characteristic
Item
see disease characteristics
boolean
C0599878 (UMLS CUI [1])
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