ID

38168

Description

A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna Gene Signature Assay; ODM derived from: https://clinicaltrials.gov/show/NCT01899079

Link

https://clinicaltrials.gov/show/NCT01899079

Keywords

Versions (1)
  1. 9/24/19 9/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 24, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01899079

English

Eligibility Breast Cancer NCT01899079

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
resected node-negative, estrogen-receptor-positive, her2-negative early- stage invasive breast cancer (t1-t2, n0, pn0 (i+), pn0 (mol+), m0)
Description

Invasive carcinoma of breast Early stage TNM Breast tumor staging | Invasive carcinoma of breast Resected Negative Lymph Node | Invasive carcinoma of breast Estrogen receptor positive HER2 Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C2363430
UMLS CUI [1,3]
C0474926
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C1521996
UMLS CUI [2,3]
C0678034
UMLS CUI [3,1]
C0853879
UMLS CUI [3,2]
C0279754
UMLS CUI [3,3]
C2348908
1. estrogen receptor status will be evaluated by immunohistochemistry (ihc)and more than 1% of stained tumor cells will be considered positive.
Description

Estrogen Receptor Status Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C1516974
UMLS CUI [1,2]
C0021044
2. her2 status will be evaluated by (ihc; 0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization.
Description

HER2 Status Immunohistochemistry | HER2 Status Fluorescent in Situ Hybridization

Data type

boolean

Alias
UMLS CUI [1,1]
C1512413
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C1512413
UMLS CUI [2,2]
C0162789
postmenopausal females, which is defined as:
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
1. natural amenorrhea > 12 months, regardless of age
Description

Amenorrhea Natural Duration | Independent of Age

Data type

boolean

Alias
UMLS CUI [1,1]
C0002453
UMLS CUI [1,2]
C0205296
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C0001779
2. bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
Description

Bilateral oophorectomy | Independent of Age

Data type

boolean

Alias
UMLS CUI [1]
C0278321
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C0001779
3. radiological castration with amenorrhea > 3 months, regardless of age
Description

Castration Radiologic | Amenorrhea Duration | Independent of Age

Data type

boolean

Alias
UMLS CUI [1,1]
C0007344
UMLS CUI [1,2]
C0205483
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0332291
UMLS CUI [3,2]
C0001779
4. hysterectomy and postmenopausal blood levels
Description

Hysterectomy | Blood Level Postmenopausal

Data type

boolean

Alias
UMLS CUI [1]
C0020699
UMLS CUI [2,1]
C0005767
UMLS CUI [2,2]
C0441889
UMLS CUI [2,3]
C0232970
able to give consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
eligible for treatment of breast cancer with adjuvant chemotherapy
Description

Eligibility Adjuvant Chemotherapy Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0085533
UMLS CUI [1,3]
C0678222
ecog performance status of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
tumor size t3-t4
Description

Tumor size TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0474926
non-invasive breast cancer (e.g., paget's disease, dcis)
Description

Breast Carcinoma Non-invasive | Paget Disease | DCIS

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205303
UMLS CUI [2]
C1368019
UMLS CUI [3]
C0007124
tumors with nodes that are not n0, pn0 (i+), or pn0 (mol+)
Description

Cancer of lymph node TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0948627
UMLS CUI [1,2]
C3258246
tumors that are estrogen-receptor negative or her2 positive
Description

Neoplasms Estrogen receptor negative | Neoplasms HER2 positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0279756
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C2348909
have metastatic disease
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
unable to give informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
unable to complete patient reported outcome surveys
Description

Outcome Surveys Completion Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0038951
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C1299582
have contraindications for adjuvant chemotherapy
Description

Medical contraindication Adjuvant Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0085533
age, performance status, significant comorbidities
Description

Age | Performance status | Comorbidity Significant

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1518965
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0750502
ecog performance status > 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
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Similar models

Eligibility Breast Cancer NCT01899079

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Early stage TNM Breast tumor staging | Invasive carcinoma of breast Resected Negative Lymph Node | Invasive carcinoma of breast Estrogen receptor positive HER2 Negative
Item
resected node-negative, estrogen-receptor-positive, her2-negative early- stage invasive breast cancer (t1-t2, n0, pn0 (i+), pn0 (mol+), m0)
boolean
C0853879 (UMLS CUI [1,1])
C2363430 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0853879 (UMLS CUI [2,1])
C1521996 (UMLS CUI [2,2])
C0678034 (UMLS CUI [2,3])
C0853879 (UMLS CUI [3,1])
C0279754 (UMLS CUI [3,2])
C2348908 (UMLS CUI [3,3])
Estrogen Receptor Status Immunohistochemistry
Item
1. estrogen receptor status will be evaluated by immunohistochemistry (ihc)and more than 1% of stained tumor cells will be considered positive.
boolean
C1516974 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
HER2 Status Immunohistochemistry | HER2 Status Fluorescent in Situ Hybridization
Item
2. her2 status will be evaluated by (ihc; 0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization.
boolean
C1512413 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1512413 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
Postmenopausal state
Item
postmenopausal females, which is defined as:
boolean
C0232970 (UMLS CUI [1])
Amenorrhea Natural Duration | Independent of Age
Item
1. natural amenorrhea > 12 months, regardless of age
boolean
C0002453 (UMLS CUI [1,1])
C0205296 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0332291 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
Bilateral oophorectomy | Independent of Age
Item
2. bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
boolean
C0278321 (UMLS CUI [1])
C0332291 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
Castration Radiologic | Amenorrhea Duration | Independent of Age
Item
3. radiological castration with amenorrhea > 3 months, regardless of age
boolean
C0007344 (UMLS CUI [1,1])
C0205483 (UMLS CUI [1,2])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0332291 (UMLS CUI [3,1])
C0001779 (UMLS CUI [3,2])
Hysterectomy | Blood Level Postmenopausal
Item
4. hysterectomy and postmenopausal blood levels
boolean
C0020699 (UMLS CUI [1])
C0005767 (UMLS CUI [2,1])
C0441889 (UMLS CUI [2,2])
C0232970 (UMLS CUI [2,3])
Informed Consent
Item
able to give consent
boolean
C0021430 (UMLS CUI [1])
Eligibility Adjuvant Chemotherapy Breast Carcinoma
Item
eligible for treatment of breast cancer with adjuvant chemotherapy
boolean
C1548635 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Tumor size TNM Breast tumor staging
Item
tumor size t3-t4
boolean
C0475440 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Breast Carcinoma Non-invasive | Paget Disease | DCIS
Item
non-invasive breast cancer (e.g., paget's disease, dcis)
boolean
C0678222 (UMLS CUI [1,1])
C0205303 (UMLS CUI [1,2])
C1368019 (UMLS CUI [2])
C0007124 (UMLS CUI [3])
Cancer of lymph node TNM clinical staging
Item
tumors with nodes that are not n0, pn0 (i+), or pn0 (mol+)
boolean
C0948627 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Neoplasms Estrogen receptor negative | Neoplasms HER2 positive
Item
tumors that are estrogen-receptor negative or her2 positive
boolean
C0027651 (UMLS CUI [1,1])
C0279756 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
Neoplasm Metastasis
Item
have metastatic disease
boolean
C0027627 (UMLS CUI [1])
Informed Consent Unable
Item
unable to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Outcome Surveys Completion Unable
Item
unable to complete patient reported outcome surveys
boolean
C1274040 (UMLS CUI [1,1])
C0038951 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Medical contraindication Adjuvant Chemotherapy
Item
have contraindications for adjuvant chemotherapy
boolean
C1301624 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
Age | Performance status | Comorbidity Significant
Item
age, performance status, significant comorbidities
boolean
C0001779 (UMLS CUI [1])
C1518965 (UMLS CUI [2])
C0009488 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
ECOG performance status
Item
ecog performance status > 1
boolean
C1520224 (UMLS CUI [1])
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